Good documentation practices in pharmaceutical industry pdf

Good documentation practices in pharmaceutical industry pdf
Good documentation practices are expected to assure they are accurate, legible and traceable to name a few. The lack of such good documentation practices are routinely cited in FDA 483 observations. This webinar will cover the basics of what good documentation practices include, along with examples of practices not acceptable to auditors. This webinar will help attendees review their …
The purposes of Good Documentation (as set out in the WHO Good Manufacturing Practices guidelines for Pharmaceutical products) are: To define the specifications and procedures for all materials and methods of manufacture and control
Good Documentation Practices (GDP) is a critical and essential part of a regulated environment (pharmaceutical and medical device manufacturing, R&D, laboratories and clinical trials). Compliance with GDP ensures an auditable account of work. It ensures integrity and control of documents and is a key requirement for a developed quality system.
Why Documentation There is a saying in the pharmaceutical industry: ‘if it hasn’t been documented, then it hasn’t happened!’ Good documentation practice constitutes an essential part of the QA system. Documentation system must be proactive vehicle of communication. Your documentation is an advertisement for your work .
Cleaning validation in the pharmaceutical industry has been a topic of ever-increasing interest and scrutiny in recent Food and Drug Administration (FDA) inspections.The validation of procedures used to clean the equipment employed during the various steps of a manufacturing process is a clear requirement of current Good Manufacturing Practice (cGMP). As such, FDA inspectors now expect …
Good Documentation Practices 4.7 Handwritten entries should be made in clear, legible, indelible way. 4.8 Records should be made or completed at the time each action is taken and in such a
Good Documentation Practices Do’s and Don’ts cGMP requirements for changing and controlling entries into documents Archiving of records Current industry practices for GDP Interactive Q&A Session. Who will Benefit: Quality Assurance Professionals Quality Control Professionals Regulatory Professionals Pharma/Medical Devices/OTC Cosmetic Manufacturing Teams Pharma/Medical …
application to laboratory activities, manufacturing good manufacturing practices in pharmaceutical industry ppt and support functions, as well as demonstrate the need for thorough and comprehensive GMP training and documentation.
Procedure for good documentation practices is essential Options for training: read and understand, instructor led training (ILT) and ILT with check for understanding Data Integrity: Praxis example of implementation of the requirements at a pharma site based on Quality Risk Management principles
necessary controls for good documentation practices for electronic data are in place and that the probability of the occurrence of errors in the data is minimized ; • training of personnel who use computerized systems and review electronic data in
Good Engineering Practices (GEPs) consist of proven and accepted engineering methods, procedures, and practices that provide appropriate, cost-effective, and well-documented solutions to meet user-requirements and compliance with applicable regulations. GEP underpins activities in the day-to-day operations and forward planning of a pharmaceutical business. The adoption of this methodology
In Pharma and Biotech, Weightage of the Documentation is around 70 % because as per FDA “If you do not have Document, You dint have do it.” So Good Documentation Practice is of tremendous importance for the Industry to comply any regulation like FDA, GMP or ISO.
WHO good manufacturing practices for pharmaceutical products: main principles1 Introduction 79 General considerations 80 Glossary 81 Quality management in the medicines industry: philosophy and essential elements 85 1. Pharmaceutical quality system 85 Quality risk management 88 Product quality review 88 2. Good manufacturing practices for pharmaceutical products 90 3. Sanitation and …

Improving Document Review Practices in Pharmaceutical

Documentation PPTauthorSTREAM
260 Introduction to Pharma Current Good Manufacturing Practice (cGMP) is an overview course that examines the basics of current good manufacturing practice (cGMP) in the pharmaceutical industry.
Documentation Is Created And Maintained In The Pharmaceutical Industry. Although The U.S. Food And Drug Although The U.S. Food And Drug Administration (FDA) Set Some GDP Standards, Others Fall Under The Current Good Manufacturing Practice
Good Documentation Practices should be everyone’s concern. Foundation of a sound documentation system begins with the engineering documents as well as their management. Engineering is the provider Production is the customer QA is the gatekeeper. Validation is the …
n overview of good documentation practices applicable to those working in the pharmaceutical and healthcare sectors is presented.
Logistics Good Distribution Practices (GDP) Certification for Pharmaceutical Industry Maintaining product safety and quality during distribution is of utmost importance in the pharmaceutical industry.
Document review practices in the research and development functions of many pharmaceutical companies can be frustrating and inefficient, at least in part because these practices are poorly managed. Although the literature on review practice is fairly robust, there is a disjuncture between what researchers know and how reviewers work. The author
down in The IPEC Good Distribution Practice Guide for Pharmaceutical Excipients, 2006. Purpose of the Document This document was written by experts from the European Industry (CEFIC APIC).
However, since pharmaceuticals is an industry and the bottom line is money, some pharmaceutical companies try to bend the rule so that their products can be declared fit for the public while the products’ effectiveness and side-effects are not fully known for everyone.

Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries.
Purpose of Laboratory Documentation To provide the basic guide for good document practices with regard to creation, approval, review, maintenance, correction or errors, verification and archiving etc Ensures documented evidence, traceability, provide records and audit trails for investigation Ensures availability of data for validation, review
Requirements for Good Documentation Practice (GDP) Ankur Choudhary Print Question Forum 1 comment Good documentation practice GDP is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of any document.
Due to the importance given to documentation in pharma “good documentation practices” is required. Good documentation is a systematic procedure of preparation, checking, verifying, issuing, storing and reviewing of any documents. Batch record is an important document kept along with reserve sample until one year of expiry of the product, and final products are release only after proper
Good Manufacturing Practices (GMP) Guidelines for Active Pharmaceutical Ingredients (GUI-0104) Consultation Notice to Stakeholders – Invitation to Participate in a Survey for Canadian Active Pharmaceutical Ingredients (API) Stakeholders [2011-03-25]
The Pharmaceutical Quality Group (PQG) was formed in 1977 to promote development of a consistent approach to pharmaceutical quality and good manufacturing practices.

PDF On Mar 8, 2017, Krishan Kumar and others published Good Documentation Practices (GDPs) in Pharmaceutical Industry
An overview of good documentation practices applicable to those working in the pharmaceutical and healthcare sectors is presented. Discover the world’s research 15+ million members
GOOD DOCUMENTATION PRACTICES (GDP) PRESENTED BY: SATYAVAN SINGH GENERAL MANAGER QUALITY INTAS PHARMACEUTICALS LIMITED SIKKIM General Principle of Documentations Design (correct, complete, current & traceable) Prepared Reviewed Proper Distribution Why …
GUEST COLUMN Documentation and Record Maintenance: A Need for Good Manufacturing Practices (GMP) Compliance in Pharma & Healthcare Industry -Zbstract
•Lack of training including hygiene practices, gowning Lack of awareness on current guideline in TRS 957 – WHO good manufacturing practices for pharmaceutical
Documentation is a key area for companies in the pharmaceutical industry. The United States Food and Drug Administration (FDA )- the governmental agency, that is responsible for overseeing the industry, requires extensive documentation for every manufacturing and packaging lot of all pharmaceutical products. The FDA mandates documentation for the sake of accountability and …
Strict documentation from project management up to test execution is obligatory here to satisfy the regulatory requirements of the pharmaceutical industry. “Good Practice” is an essential part of validation, where suitability for the intended purpose is to be proven.
Current Good Manufacturing Practices Checklist For Pharmaceutical Manufacturers Current Good Manufacturing Practices (“cGMPs” or “GMPs”) for pharmaceutical manufacturers provide the methods and controls used for the manufacturing, processing, packaging or holding of a pharmaceutical to assure that the pharmaceutical meets the minimum safety requirements of the Federal Food, Drug …
• Sustaining Good Documentation Practices. Who Will Be the Next Poster Child Source: Washington Post, Sept 26,2015 3. Background •Data Integrity is “The degree to which a collection of data is complete, consistent, and accurate” Source: FDA Glossary of Computer Systems Software Development Terminology (8/95) •Two main areas of concern regarding data integrity in CGMP …
SOP on Good Documentation Practices Pharmaceutical Guidance
Objective :To lay down the procedure for Good Documentation Practices in facility. Scope:This standard operating procedure is applicable to all departments involved in documentation activities throughout the facility of Pharmaceutical Company (Name). – good example of positive feedback mechanism would be

ALCOA in Pharmaceuticals A necessary tool for Quality

Cleaning Validation in the Pharmaceutical Industry

Good Documentation Practices Quality Assurance

People Aspects Ensuring Training Resources and

Good Documentation Guideline US Pharmacopeia General

Documentation and Record Maintanance- A Need of Good

Good documentation practice SlideShare

https://en.m.wikipedia.org/wiki/Corrective_and_preventive_action
Documentation in GMP (Good Manufacturing Practices
good food and travel guide – GOOD DOCUMENTATION PRACTICE IN PHARMACEUTICALS
Current Good Manufacturing Practices Checklist For

Good Documentation Practices – Webinar Compliance

Good Documentation Practices – Compliance Trainings

Good Documentation Practices – Compliance Trainings
Current Good Manufacturing Practices Checklist For

Good Manufacturing Practices (GMP) Guidelines for Active Pharmaceutical Ingredients (GUI-0104) Consultation Notice to Stakeholders – Invitation to Participate in a Survey for Canadian Active Pharmaceutical Ingredients (API) Stakeholders [2011-03-25]
• Sustaining Good Documentation Practices. Who Will Be the Next Poster Child Source: Washington Post, Sept 26,2015 3. Background •Data Integrity is “The degree to which a collection of data is complete, consistent, and accurate” Source: FDA Glossary of Computer Systems Software Development Terminology (8/95) •Two main areas of concern regarding data integrity in CGMP …
Good Documentation Practices Do’s and Don’ts cGMP requirements for changing and controlling entries into documents Archiving of records Current industry practices for GDP Interactive Q&A Session. Who will Benefit: Quality Assurance Professionals Quality Control Professionals Regulatory Professionals Pharma/Medical Devices/OTC Cosmetic Manufacturing Teams Pharma/Medical …
Good Documentation Practices (GDP) is a critical and essential part of a regulated environment (pharmaceutical and medical device manufacturing, R&D, laboratories and clinical trials). Compliance with GDP ensures an auditable account of work. It ensures integrity and control of documents and is a key requirement for a developed quality system.
Logistics Good Distribution Practices (GDP) Certification for Pharmaceutical Industry Maintaining product safety and quality during distribution is of utmost importance in the pharmaceutical industry.
Good Documentation Practices 4.7 Handwritten entries should be made in clear, legible, indelible way. 4.8 Records should be made or completed at the time each action is taken and in such a
Objective :To lay down the procedure for Good Documentation Practices in facility. Scope:This standard operating procedure is applicable to all departments involved in documentation activities throughout the facility of Pharmaceutical Company (Name).
The purposes of Good Documentation (as set out in the WHO Good Manufacturing Practices guidelines for Pharmaceutical products) are: To define the specifications and procedures for all materials and methods of manufacture and control
Purpose of Laboratory Documentation To provide the basic guide for good document practices with regard to creation, approval, review, maintenance, correction or errors, verification and archiving etc Ensures documented evidence, traceability, provide records and audit trails for investigation Ensures availability of data for validation, review
An overview of good documentation practices applicable to those working in the pharmaceutical and healthcare sectors is presented. Discover the world’s research 15 million members
Cleaning validation in the pharmaceutical industry has been a topic of ever-increasing interest and scrutiny in recent Food and Drug Administration (FDA) inspections.The validation of procedures used to clean the equipment employed during the various steps of a manufacturing process is a clear requirement of current Good Manufacturing Practice (cGMP). As such, FDA inspectors now expect …

Current Good Manufacturing Practices Checklist For
Data Integrity and Good Documentation Practice ECA Academy

Good Engineering Practices (GEPs) consist of proven and accepted engineering methods, procedures, and practices that provide appropriate, cost-effective, and well-documented solutions to meet user-requirements and compliance with applicable regulations. GEP underpins activities in the day-to-day operations and forward planning of a pharmaceutical business. The adoption of this methodology
Cleaning validation in the pharmaceutical industry has been a topic of ever-increasing interest and scrutiny in recent Food and Drug Administration (FDA) inspections.The validation of procedures used to clean the equipment employed during the various steps of a manufacturing process is a clear requirement of current Good Manufacturing Practice (cGMP). As such, FDA inspectors now expect …
260 Introduction to Pharma Current Good Manufacturing Practice (cGMP) is an overview course that examines the basics of current good manufacturing practice (cGMP) in the pharmaceutical industry.
•Lack of training including hygiene practices, gowning Lack of awareness on current guideline in TRS 957 – WHO good manufacturing practices for pharmaceutical
An overview of good documentation practices applicable to those working in the pharmaceutical and healthcare sectors is presented. Discover the world’s research 15 million members
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries.
However, since pharmaceuticals is an industry and the bottom line is money, some pharmaceutical companies try to bend the rule so that their products can be declared fit for the public while the products’ effectiveness and side-effects are not fully known for everyone.
Current Good Manufacturing Practices Checklist For Pharmaceutical Manufacturers Current Good Manufacturing Practices (“cGMPs” or “GMPs”) for pharmaceutical manufacturers provide the methods and controls used for the manufacturing, processing, packaging or holding of a pharmaceutical to assure that the pharmaceutical meets the minimum safety requirements of the Federal Food, Drug …
Due to the importance given to documentation in pharma “good documentation practices” is required. Good documentation is a systematic procedure of preparation, checking, verifying, issuing, storing and reviewing of any documents. Batch record is an important document kept along with reserve sample until one year of expiry of the product, and final products are release only after proper
WHO good manufacturing practices for pharmaceutical products: main principles1 Introduction 79 General considerations 80 Glossary 81 Quality management in the medicines industry: philosophy and essential elements 85 1. Pharmaceutical quality system 85 Quality risk management 88 Product quality review 88 2. Good manufacturing practices for pharmaceutical products 90 3. Sanitation and …

Requirements for Good Documentation Practice (GDP
Good Documentation Practices – Compliance Trainings

GUEST COLUMN Documentation and Record Maintenance: A Need for Good Manufacturing Practices (GMP) Compliance in Pharma & Healthcare Industry -Zbstract
n overview of good documentation practices applicable to those working in the pharmaceutical and healthcare sectors is presented.
application to laboratory activities, manufacturing good manufacturing practices in pharmaceutical industry ppt and support functions, as well as demonstrate the need for thorough and comprehensive GMP training and documentation.
Procedure for good documentation practices is essential Options for training: read and understand, instructor led training (ILT) and ILT with check for understanding Data Integrity: Praxis example of implementation of the requirements at a pharma site based on Quality Risk Management principles
However, since pharmaceuticals is an industry and the bottom line is money, some pharmaceutical companies try to bend the rule so that their products can be declared fit for the public while the products’ effectiveness and side-effects are not fully known for everyone.
Objective :To lay down the procedure for Good Documentation Practices in facility. Scope:This standard operating procedure is applicable to all departments involved in documentation activities throughout the facility of Pharmaceutical Company (Name).
• Sustaining Good Documentation Practices. Who Will Be the Next Poster Child Source: Washington Post, Sept 26,2015 3. Background •Data Integrity is “The degree to which a collection of data is complete, consistent, and accurate” Source: FDA Glossary of Computer Systems Software Development Terminology (8/95) •Two main areas of concern regarding data integrity in CGMP …

ALCOA in Pharmaceuticals A necessary tool for Quality
Good Documentation Guideline US Pharmacopeia General

down in The IPEC Good Distribution Practice Guide for Pharmaceutical Excipients, 2006. Purpose of the Document This document was written by experts from the European Industry (CEFIC APIC).
• Sustaining Good Documentation Practices. Who Will Be the Next Poster Child Source: Washington Post, Sept 26,2015 3. Background •Data Integrity is “The degree to which a collection of data is complete, consistent, and accurate” Source: FDA Glossary of Computer Systems Software Development Terminology (8/95) •Two main areas of concern regarding data integrity in CGMP …
Procedure for good documentation practices is essential Options for training: read and understand, instructor led training (ILT) and ILT with check for understanding Data Integrity: Praxis example of implementation of the requirements at a pharma site based on Quality Risk Management principles
Cleaning validation in the pharmaceutical industry has been a topic of ever-increasing interest and scrutiny in recent Food and Drug Administration (FDA) inspections.The validation of procedures used to clean the equipment employed during the various steps of a manufacturing process is a clear requirement of current Good Manufacturing Practice (cGMP). As such, FDA inspectors now expect …
Good Engineering Practices (GEPs) consist of proven and accepted engineering methods, procedures, and practices that provide appropriate, cost-effective, and well-documented solutions to meet user-requirements and compliance with applicable regulations. GEP underpins activities in the day-to-day operations and forward planning of a pharmaceutical business. The adoption of this methodology
Good Documentation Practices 4.7 Handwritten entries should be made in clear, legible, indelible way. 4.8 Records should be made or completed at the time each action is taken and in such a
Documentation Is Created And Maintained In The Pharmaceutical Industry. Although The U.S. Food And Drug Although The U.S. Food And Drug Administration (FDA) Set Some GDP Standards, Others Fall Under The Current Good Manufacturing Practice
An overview of good documentation practices applicable to those working in the pharmaceutical and healthcare sectors is presented. Discover the world’s research 15 million members
However, since pharmaceuticals is an industry and the bottom line is money, some pharmaceutical companies try to bend the rule so that their products can be declared fit for the public while the products’ effectiveness and side-effects are not fully known for everyone.
Objective :To lay down the procedure for Good Documentation Practices in facility. Scope:This standard operating procedure is applicable to all departments involved in documentation activities throughout the facility of Pharmaceutical Company (Name).
•Lack of training including hygiene practices, gowning Lack of awareness on current guideline in TRS 957 – WHO good manufacturing practices for pharmaceutical

Documentation PPTauthorSTREAM
Good documentation practice SlideShare

Good documentation practices are expected to assure they are accurate, legible and traceable to name a few. The lack of such good documentation practices are routinely cited in FDA 483 observations. This webinar will cover the basics of what good documentation practices include, along with examples of practices not acceptable to auditors. This webinar will help attendees review their …
application to laboratory activities, manufacturing good manufacturing practices in pharmaceutical industry ppt and support functions, as well as demonstrate the need for thorough and comprehensive GMP training and documentation.
Objective :To lay down the procedure for Good Documentation Practices in facility. Scope:This standard operating procedure is applicable to all departments involved in documentation activities throughout the facility of Pharmaceutical Company (Name).
n overview of good documentation practices applicable to those working in the pharmaceutical and healthcare sectors is presented.
Cleaning validation in the pharmaceutical industry has been a topic of ever-increasing interest and scrutiny in recent Food and Drug Administration (FDA) inspections.The validation of procedures used to clean the equipment employed during the various steps of a manufacturing process is a clear requirement of current Good Manufacturing Practice (cGMP). As such, FDA inspectors now expect …
Logistics Good Distribution Practices (GDP) Certification for Pharmaceutical Industry Maintaining product safety and quality during distribution is of utmost importance in the pharmaceutical industry.
Document review practices in the research and development functions of many pharmaceutical companies can be frustrating and inefficient, at least in part because these practices are poorly managed. Although the literature on review practice is fairly robust, there is a disjuncture between what researchers know and how reviewers work. The author
Good Documentation Practices Do’s and Don’ts cGMP requirements for changing and controlling entries into documents Archiving of records Current industry practices for GDP Interactive Q&A Session. Who will Benefit: Quality Assurance Professionals Quality Control Professionals Regulatory Professionals Pharma/Medical Devices/OTC Cosmetic Manufacturing Teams Pharma/Medical …
Strict documentation from project management up to test execution is obligatory here to satisfy the regulatory requirements of the pharmaceutical industry. “Good Practice” is an essential part of validation, where suitability for the intended purpose is to be proven.
Good Engineering Practices (GEPs) consist of proven and accepted engineering methods, procedures, and practices that provide appropriate, cost-effective, and well-documented solutions to meet user-requirements and compliance with applicable regulations. GEP underpins activities in the day-to-day operations and forward planning of a pharmaceutical business. The adoption of this methodology
Requirements for Good Documentation Practice (GDP) Ankur Choudhary Print Question Forum 1 comment Good documentation practice GDP is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of any document.
In Pharma and Biotech, Weightage of the Documentation is around 70 % because as per FDA “If you do not have Document, You dint have do it.” So Good Documentation Practice is of tremendous importance for the Industry to comply any regulation like FDA, GMP or ISO.
down in The IPEC Good Distribution Practice Guide for Pharmaceutical Excipients, 2006. Purpose of the Document This document was written by experts from the European Industry (CEFIC APIC).
necessary controls for good documentation practices for electronic data are in place and that the probability of the occurrence of errors in the data is minimized ; • training of personnel who use computerized systems and review electronic data in
WHO good manufacturing practices for pharmaceutical products: main principles1 Introduction 79 General considerations 80 Glossary 81 Quality management in the medicines industry: philosophy and essential elements 85 1. Pharmaceutical quality system 85 Quality risk management 88 Product quality review 88 2. Good manufacturing practices for pharmaceutical products 90 3. Sanitation and …

Good documentation practice SlideShare
Documentation and Record Maintanance- A Need of Good

The purposes of Good Documentation (as set out in the WHO Good Manufacturing Practices guidelines for Pharmaceutical products) are: To define the specifications and procedures for all materials and methods of manufacture and control
necessary controls for good documentation practices for electronic data are in place and that the probability of the occurrence of errors in the data is minimized ; • training of personnel who use computerized systems and review electronic data in
Good Engineering Practices (GEPs) consist of proven and accepted engineering methods, procedures, and practices that provide appropriate, cost-effective, and well-documented solutions to meet user-requirements and compliance with applicable regulations. GEP underpins activities in the day-to-day operations and forward planning of a pharmaceutical business. The adoption of this methodology
However, since pharmaceuticals is an industry and the bottom line is money, some pharmaceutical companies try to bend the rule so that their products can be declared fit for the public while the products’ effectiveness and side-effects are not fully known for everyone.
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries.
Purpose of Laboratory Documentation To provide the basic guide for good document practices with regard to creation, approval, review, maintenance, correction or errors, verification and archiving etc Ensures documented evidence, traceability, provide records and audit trails for investigation Ensures availability of data for validation, review

Requirements for Good Documentation Practice (GDP
SOP on Good Documentation Practices Pharmaceutical Guidance

Good Documentation Practices 4.7 Handwritten entries should be made in clear, legible, indelible way. 4.8 Records should be made or completed at the time each action is taken and in such a
Documentation Is Created And Maintained In The Pharmaceutical Industry. Although The U.S. Food And Drug Although The U.S. Food And Drug Administration (FDA) Set Some GDP Standards, Others Fall Under The Current Good Manufacturing Practice
Procedure for good documentation practices is essential Options for training: read and understand, instructor led training (ILT) and ILT with check for understanding Data Integrity: Praxis example of implementation of the requirements at a pharma site based on Quality Risk Management principles
Why Documentation There is a saying in the pharmaceutical industry: ‘if it hasn’t been documented, then it hasn’t happened!’ Good documentation practice constitutes an essential part of the QA system. Documentation system must be proactive vehicle of communication. Your documentation is an advertisement for your work .
•Lack of training including hygiene practices, gowning Lack of awareness on current guideline in TRS 957 – WHO good manufacturing practices for pharmaceutical
necessary controls for good documentation practices for electronic data are in place and that the probability of the occurrence of errors in the data is minimized ; • training of personnel who use computerized systems and review electronic data in
260 Introduction to Pharma Current Good Manufacturing Practice (cGMP) is an overview course that examines the basics of current good manufacturing practice (cGMP) in the pharmaceutical industry.
Documentation is a key area for companies in the pharmaceutical industry. The United States Food and Drug Administration (FDA )- the governmental agency, that is responsible for overseeing the industry, requires extensive documentation for every manufacturing and packaging lot of all pharmaceutical products. The FDA mandates documentation for the sake of accountability and …
However, since pharmaceuticals is an industry and the bottom line is money, some pharmaceutical companies try to bend the rule so that their products can be declared fit for the public while the products’ effectiveness and side-effects are not fully known for everyone.

Documentation and Record Maintanance- A Need of Good
Pharmaceutical Documentation SlideShare

Good documentation practices are expected to assure they are accurate, legible and traceable to name a few. The lack of such good documentation practices are routinely cited in FDA 483 observations. This webinar will cover the basics of what good documentation practices include, along with examples of practices not acceptable to auditors. This webinar will help attendees review their …
Cleaning validation in the pharmaceutical industry has been a topic of ever-increasing interest and scrutiny in recent Food and Drug Administration (FDA) inspections.The validation of procedures used to clean the equipment employed during the various steps of a manufacturing process is a clear requirement of current Good Manufacturing Practice (cGMP). As such, FDA inspectors now expect …
Document review practices in the research and development functions of many pharmaceutical companies can be frustrating and inefficient, at least in part because these practices are poorly managed. Although the literature on review practice is fairly robust, there is a disjuncture between what researchers know and how reviewers work. The author
In Pharma and Biotech, Weightage of the Documentation is around 70 % because as per FDA “If you do not have Document, You dint have do it.” So Good Documentation Practice is of tremendous importance for the Industry to comply any regulation like FDA, GMP or ISO.
Good Documentation Practices 4.7 Handwritten entries should be made in clear, legible, indelible way. 4.8 Records should be made or completed at the time each action is taken and in such a
PDF On Mar 8, 2017, Krishan Kumar and others published Good Documentation Practices (GDPs) in Pharmaceutical Industry
Objective :To lay down the procedure for Good Documentation Practices in facility. Scope:This standard operating procedure is applicable to all departments involved in documentation activities throughout the facility of Pharmaceutical Company (Name).
Good Documentation Practices Do’s and Don’ts cGMP requirements for changing and controlling entries into documents Archiving of records Current industry practices for GDP Interactive Q&A Session. Who will Benefit: Quality Assurance Professionals Quality Control Professionals Regulatory Professionals Pharma/Medical Devices/OTC Cosmetic Manufacturing Teams Pharma/Medical …
Good Engineering Practices (GEPs) consist of proven and accepted engineering methods, procedures, and practices that provide appropriate, cost-effective, and well-documented solutions to meet user-requirements and compliance with applicable regulations. GEP underpins activities in the day-to-day operations and forward planning of a pharmaceutical business. The adoption of this methodology

Good Documentation Practices – Compliance Trainings
GOOD DOCUMENTATION PRACTICE Assocham India

Why Documentation There is a saying in the pharmaceutical industry: ‘if it hasn’t been documented, then it hasn’t happened!’ Good documentation practice constitutes an essential part of the QA system. Documentation system must be proactive vehicle of communication. Your documentation is an advertisement for your work .
The purposes of Good Documentation (as set out in the WHO Good Manufacturing Practices guidelines for Pharmaceutical products) are: To define the specifications and procedures for all materials and methods of manufacture and control
GOOD DOCUMENTATION PRACTICES (GDP) PRESENTED BY: SATYAVAN SINGH GENERAL MANAGER QUALITY INTAS PHARMACEUTICALS LIMITED SIKKIM General Principle of Documentations Design (correct, complete, current & traceable) Prepared Reviewed Proper Distribution Why …
Document review practices in the research and development functions of many pharmaceutical companies can be frustrating and inefficient, at least in part because these practices are poorly managed. Although the literature on review practice is fairly robust, there is a disjuncture between what researchers know and how reviewers work. The author

Good Documentation Practices – Webinar Compliance
Good Documentation Guideline US Pharmacopeia General

Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries.
Logistics Good Distribution Practices (GDP) Certification for Pharmaceutical Industry Maintaining product safety and quality during distribution is of utmost importance in the pharmaceutical industry.
The purposes of Good Documentation (as set out in the WHO Good Manufacturing Practices guidelines for Pharmaceutical products) are: To define the specifications and procedures for all materials and methods of manufacture and control
•Lack of training including hygiene practices, gowning Lack of awareness on current guideline in TRS 957 – WHO good manufacturing practices for pharmaceutical
Good Documentation Practices Do’s and Don’ts cGMP requirements for changing and controlling entries into documents Archiving of records Current industry practices for GDP Interactive Q&A Session. Who will Benefit: Quality Assurance Professionals Quality Control Professionals Regulatory Professionals Pharma/Medical Devices/OTC Cosmetic Manufacturing Teams Pharma/Medical …
application to laboratory activities, manufacturing good manufacturing practices in pharmaceutical industry ppt and support functions, as well as demonstrate the need for thorough and comprehensive GMP training and documentation.
PDF On Mar 8, 2017, Krishan Kumar and others published Good Documentation Practices (GDPs) in Pharmaceutical Industry
An overview of good documentation practices applicable to those working in the pharmaceutical and healthcare sectors is presented. Discover the world’s research 15 million members
Strict documentation from project management up to test execution is obligatory here to satisfy the regulatory requirements of the pharmaceutical industry. “Good Practice” is an essential part of validation, where suitability for the intended purpose is to be proven.
Good Documentation Practices 4.7 Handwritten entries should be made in clear, legible, indelible way. 4.8 Records should be made or completed at the time each action is taken and in such a
The Pharmaceutical Quality Group (PQG) was formed in 1977 to promote development of a consistent approach to pharmaceutical quality and good manufacturing practices.
However, since pharmaceuticals is an industry and the bottom line is money, some pharmaceutical companies try to bend the rule so that their products can be declared fit for the public while the products’ effectiveness and side-effects are not fully known for everyone.

GOOD DOCUMENTATION PRACTICE Assocham India
Improving Document Review Practices in Pharmaceutical

Good Documentation Practices Do’s and Don’ts cGMP requirements for changing and controlling entries into documents Archiving of records Current industry practices for GDP Interactive Q&A Session. Who will Benefit: Quality Assurance Professionals Quality Control Professionals Regulatory Professionals Pharma/Medical Devices/OTC Cosmetic Manufacturing Teams Pharma/Medical …
Objective :To lay down the procedure for Good Documentation Practices in facility. Scope:This standard operating procedure is applicable to all departments involved in documentation activities throughout the facility of Pharmaceutical Company (Name).
Cleaning validation in the pharmaceutical industry has been a topic of ever-increasing interest and scrutiny in recent Food and Drug Administration (FDA) inspections.The validation of procedures used to clean the equipment employed during the various steps of a manufacturing process is a clear requirement of current Good Manufacturing Practice (cGMP). As such, FDA inspectors now expect …
Documentation is a key area for companies in the pharmaceutical industry. The United States Food and Drug Administration (FDA )- the governmental agency, that is responsible for overseeing the industry, requires extensive documentation for every manufacturing and packaging lot of all pharmaceutical products. The FDA mandates documentation for the sake of accountability and …
Good Manufacturing Practices (GMP) Guidelines for Active Pharmaceutical Ingredients (GUI-0104) Consultation Notice to Stakeholders – Invitation to Participate in a Survey for Canadian Active Pharmaceutical Ingredients (API) Stakeholders [2011-03-25]
Good Documentation Practices 4.7 Handwritten entries should be made in clear, legible, indelible way. 4.8 Records should be made or completed at the time each action is taken and in such a
Good Documentation Practices should be everyone’s concern. Foundation of a sound documentation system begins with the engineering documents as well as their management. Engineering is the provider Production is the customer QA is the gatekeeper. Validation is the …
GOOD DOCUMENTATION PRACTICES (GDP) PRESENTED BY: SATYAVAN SINGH GENERAL MANAGER QUALITY INTAS PHARMACEUTICALS LIMITED SIKKIM General Principle of Documentations Design (correct, complete, current & traceable) Prepared Reviewed Proper Distribution Why …
Document review practices in the research and development functions of many pharmaceutical companies can be frustrating and inefficient, at least in part because these practices are poorly managed. Although the literature on review practice is fairly robust, there is a disjuncture between what researchers know and how reviewers work. The author
Procedure for good documentation practices is essential Options for training: read and understand, instructor led training (ILT) and ILT with check for understanding Data Integrity: Praxis example of implementation of the requirements at a pharma site based on Quality Risk Management principles
down in The IPEC Good Distribution Practice Guide for Pharmaceutical Excipients, 2006. Purpose of the Document This document was written by experts from the European Industry (CEFIC APIC).

Good Documentation Practices – Compliance Trainings
Good Documentation Practices to Support Computer System

GOOD DOCUMENTATION PRACTICES (GDP) PRESENTED BY: SATYAVAN SINGH GENERAL MANAGER QUALITY INTAS PHARMACEUTICALS LIMITED SIKKIM General Principle of Documentations Design (correct, complete, current & traceable) Prepared Reviewed Proper Distribution Why …
Documentation Is Created And Maintained In The Pharmaceutical Industry. Although The U.S. Food And Drug Although The U.S. Food And Drug Administration (FDA) Set Some GDP Standards, Others Fall Under The Current Good Manufacturing Practice
application to laboratory activities, manufacturing good manufacturing practices in pharmaceutical industry ppt and support functions, as well as demonstrate the need for thorough and comprehensive GMP training and documentation.
An overview of good documentation practices applicable to those working in the pharmaceutical and healthcare sectors is presented. Discover the world’s research 15 million members

Data Integrity and Good Documentation Practice ECA Academy
Documentation in GMP (Good Manufacturing Practices

Due to the importance given to documentation in pharma “good documentation practices” is required. Good documentation is a systematic procedure of preparation, checking, verifying, issuing, storing and reviewing of any documents. Batch record is an important document kept along with reserve sample until one year of expiry of the product, and final products are release only after proper
However, since pharmaceuticals is an industry and the bottom line is money, some pharmaceutical companies try to bend the rule so that their products can be declared fit for the public while the products’ effectiveness and side-effects are not fully known for everyone.
GOOD DOCUMENTATION PRACTICES (GDP) PRESENTED BY: SATYAVAN SINGH GENERAL MANAGER QUALITY INTAS PHARMACEUTICALS LIMITED SIKKIM General Principle of Documentations Design (correct, complete, current & traceable) Prepared Reviewed Proper Distribution Why …
Good Documentation Practices (GDP) is a critical and essential part of a regulated environment (pharmaceutical and medical device manufacturing, R&D, laboratories and clinical trials). Compliance with GDP ensures an auditable account of work. It ensures integrity and control of documents and is a key requirement for a developed quality system.
In Pharma and Biotech, Weightage of the Documentation is around 70 % because as per FDA “If you do not have Document, You dint have do it.” So Good Documentation Practice is of tremendous importance for the Industry to comply any regulation like FDA, GMP or ISO.
Logistics Good Distribution Practices (GDP) Certification for Pharmaceutical Industry Maintaining product safety and quality during distribution is of utmost importance in the pharmaceutical industry.
Purpose of Laboratory Documentation To provide the basic guide for good document practices with regard to creation, approval, review, maintenance, correction or errors, verification and archiving etc Ensures documented evidence, traceability, provide records and audit trails for investigation Ensures availability of data for validation, review
PDF On Mar 8, 2017, Krishan Kumar and others published Good Documentation Practices (GDPs) in Pharmaceutical Industry
n overview of good documentation practices applicable to those working in the pharmaceutical and healthcare sectors is presented.
Good Manufacturing Practices (GMP) Guidelines for Active Pharmaceutical Ingredients (GUI-0104) Consultation Notice to Stakeholders – Invitation to Participate in a Survey for Canadian Active Pharmaceutical Ingredients (API) Stakeholders [2011-03-25]
The purposes of Good Documentation (as set out in the WHO Good Manufacturing Practices guidelines for Pharmaceutical products) are: To define the specifications and procedures for all materials and methods of manufacture and control

Documentation and Record Maintanance- A Need of Good
People Aspects Ensuring Training Resources and

Procedure for good documentation practices is essential Options for training: read and understand, instructor led training (ILT) and ILT with check for understanding Data Integrity: Praxis example of implementation of the requirements at a pharma site based on Quality Risk Management principles
Document review practices in the research and development functions of many pharmaceutical companies can be frustrating and inefficient, at least in part because these practices are poorly managed. Although the literature on review practice is fairly robust, there is a disjuncture between what researchers know and how reviewers work. The author
Cleaning validation in the pharmaceutical industry has been a topic of ever-increasing interest and scrutiny in recent Food and Drug Administration (FDA) inspections.The validation of procedures used to clean the equipment employed during the various steps of a manufacturing process is a clear requirement of current Good Manufacturing Practice (cGMP). As such, FDA inspectors now expect …
Documentation is a key area for companies in the pharmaceutical industry. The United States Food and Drug Administration (FDA )- the governmental agency, that is responsible for overseeing the industry, requires extensive documentation for every manufacturing and packaging lot of all pharmaceutical products. The FDA mandates documentation for the sake of accountability and …
Good Documentation Practices 4.7 Handwritten entries should be made in clear, legible, indelible way. 4.8 Records should be made or completed at the time each action is taken and in such a
application to laboratory activities, manufacturing good manufacturing practices in pharmaceutical industry ppt and support functions, as well as demonstrate the need for thorough and comprehensive GMP training and documentation.
Good Manufacturing Practices (GMP) Guidelines for Active Pharmaceutical Ingredients (GUI-0104) Consultation Notice to Stakeholders – Invitation to Participate in a Survey for Canadian Active Pharmaceutical Ingredients (API) Stakeholders [2011-03-25]
Objective :To lay down the procedure for Good Documentation Practices in facility. Scope:This standard operating procedure is applicable to all departments involved in documentation activities throughout the facility of Pharmaceutical Company (Name).

Documentation and Record Maintanance- A Need of Good
Cleaning Validation in the Pharmaceutical Industry

The purposes of Good Documentation (as set out in the WHO Good Manufacturing Practices guidelines for Pharmaceutical products) are: To define the specifications and procedures for all materials and methods of manufacture and control
PDF On Mar 8, 2017, Krishan Kumar and others published Good Documentation Practices (GDPs) in Pharmaceutical Industry
Good documentation practices are expected to assure they are accurate, legible and traceable to name a few. The lack of such good documentation practices are routinely cited in FDA 483 observations. This webinar will cover the basics of what good documentation practices include, along with examples of practices not acceptable to auditors. This webinar will help attendees review their …
down in The IPEC Good Distribution Practice Guide for Pharmaceutical Excipients, 2006. Purpose of the Document This document was written by experts from the European Industry (CEFIC APIC).
Strict documentation from project management up to test execution is obligatory here to satisfy the regulatory requirements of the pharmaceutical industry. “Good Practice” is an essential part of validation, where suitability for the intended purpose is to be proven.
An overview of good documentation practices applicable to those working in the pharmaceutical and healthcare sectors is presented. Discover the world’s research 15 million members

EU-GMP Guideline Chapter 4 Documentation
Improving Document Review Practices in Pharmaceutical

Strict documentation from project management up to test execution is obligatory here to satisfy the regulatory requirements of the pharmaceutical industry. “Good Practice” is an essential part of validation, where suitability for the intended purpose is to be proven.
GUEST COLUMN Documentation and Record Maintenance: A Need for Good Manufacturing Practices (GMP) Compliance in Pharma & Healthcare Industry -Zbstract
Purpose of Laboratory Documentation To provide the basic guide for good document practices with regard to creation, approval, review, maintenance, correction or errors, verification and archiving etc Ensures documented evidence, traceability, provide records and audit trails for investigation Ensures availability of data for validation, review
Requirements for Good Documentation Practice (GDP) Ankur Choudhary Print Question Forum 1 comment Good documentation practice GDP is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of any document.
n overview of good documentation practices applicable to those working in the pharmaceutical and healthcare sectors is presented.
Good Documentation Practices (GDP) is a critical and essential part of a regulated environment (pharmaceutical and medical device manufacturing, R&D, laboratories and clinical trials). Compliance with GDP ensures an auditable account of work. It ensures integrity and control of documents and is a key requirement for a developed quality system.
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries.
Good Documentation Practices Do’s and Don’ts cGMP requirements for changing and controlling entries into documents Archiving of records Current industry practices for GDP Interactive Q&A Session. Who will Benefit: Quality Assurance Professionals Quality Control Professionals Regulatory Professionals Pharma/Medical Devices/OTC Cosmetic Manufacturing Teams Pharma/Medical …
However, since pharmaceuticals is an industry and the bottom line is money, some pharmaceutical companies try to bend the rule so that their products can be declared fit for the public while the products’ effectiveness and side-effects are not fully known for everyone.
Logistics Good Distribution Practices (GDP) Certification for Pharmaceutical Industry Maintaining product safety and quality during distribution is of utmost importance in the pharmaceutical industry.
Documentation Is Created And Maintained In The Pharmaceutical Industry. Although The U.S. Food And Drug Although The U.S. Food And Drug Administration (FDA) Set Some GDP Standards, Others Fall Under The Current Good Manufacturing Practice
WHO good manufacturing practices for pharmaceutical products: main principles1 Introduction 79 General considerations 80 Glossary 81 Quality management in the medicines industry: philosophy and essential elements 85 1. Pharmaceutical quality system 85 Quality risk management 88 Product quality review 88 2. Good manufacturing practices for pharmaceutical products 90 3. Sanitation and …

Data Integrity and Good Documentation Practice ECA Academy
EU-GMP Guideline Chapter 4 Documentation

Good Manufacturing Practices (GMP) Guidelines for Active Pharmaceutical Ingredients (GUI-0104) Consultation Notice to Stakeholders – Invitation to Participate in a Survey for Canadian Active Pharmaceutical Ingredients (API) Stakeholders [2011-03-25]
Cleaning validation in the pharmaceutical industry has been a topic of ever-increasing interest and scrutiny in recent Food and Drug Administration (FDA) inspections.The validation of procedures used to clean the equipment employed during the various steps of a manufacturing process is a clear requirement of current Good Manufacturing Practice (cGMP). As such, FDA inspectors now expect …
GUEST COLUMN Documentation and Record Maintenance: A Need for Good Manufacturing Practices (GMP) Compliance in Pharma & Healthcare Industry -Zbstract
Good Engineering Practices (GEPs) consist of proven and accepted engineering methods, procedures, and practices that provide appropriate, cost-effective, and well-documented solutions to meet user-requirements and compliance with applicable regulations. GEP underpins activities in the day-to-day operations and forward planning of a pharmaceutical business. The adoption of this methodology
down in The IPEC Good Distribution Practice Guide for Pharmaceutical Excipients, 2006. Purpose of the Document This document was written by experts from the European Industry (CEFIC APIC).
Good Documentation Practices Do’s and Don’ts cGMP requirements for changing and controlling entries into documents Archiving of records Current industry practices for GDP Interactive Q&A Session. Who will Benefit: Quality Assurance Professionals Quality Control Professionals Regulatory Professionals Pharma/Medical Devices/OTC Cosmetic Manufacturing Teams Pharma/Medical …
application to laboratory activities, manufacturing good manufacturing practices in pharmaceutical industry ppt and support functions, as well as demonstrate the need for thorough and comprehensive GMP training and documentation.
Good documentation practices are expected to assure they are accurate, legible and traceable to name a few. The lack of such good documentation practices are routinely cited in FDA 483 observations. This webinar will cover the basics of what good documentation practices include, along with examples of practices not acceptable to auditors. This webinar will help attendees review their …
• Sustaining Good Documentation Practices. Who Will Be the Next Poster Child Source: Washington Post, Sept 26,2015 3. Background •Data Integrity is “The degree to which a collection of data is complete, consistent, and accurate” Source: FDA Glossary of Computer Systems Software Development Terminology (8/95) •Two main areas of concern regarding data integrity in CGMP …
However, since pharmaceuticals is an industry and the bottom line is money, some pharmaceutical companies try to bend the rule so that their products can be declared fit for the public while the products’ effectiveness and side-effects are not fully known for everyone.
WHO good manufacturing practices for pharmaceutical products: main principles1 Introduction 79 General considerations 80 Glossary 81 Quality management in the medicines industry: philosophy and essential elements 85 1. Pharmaceutical quality system 85 Quality risk management 88 Product quality review 88 2. Good manufacturing practices for pharmaceutical products 90 3. Sanitation and …
Purpose of Laboratory Documentation To provide the basic guide for good document practices with regard to creation, approval, review, maintenance, correction or errors, verification and archiving etc Ensures documented evidence, traceability, provide records and audit trails for investigation Ensures availability of data for validation, review

People Aspects Ensuring Training Resources and
Documentation PPTauthorSTREAM

260 Introduction to Pharma Current Good Manufacturing Practice (cGMP) is an overview course that examines the basics of current good manufacturing practice (cGMP) in the pharmaceutical industry.
Good documentation practices are expected to assure they are accurate, legible and traceable to name a few. The lack of such good documentation practices are routinely cited in FDA 483 observations. This webinar will cover the basics of what good documentation practices include, along with examples of practices not acceptable to auditors. This webinar will help attendees review their …
Good Engineering Practices (GEPs) consist of proven and accepted engineering methods, procedures, and practices that provide appropriate, cost-effective, and well-documented solutions to meet user-requirements and compliance with applicable regulations. GEP underpins activities in the day-to-day operations and forward planning of a pharmaceutical business. The adoption of this methodology
Documentation Is Created And Maintained In The Pharmaceutical Industry. Although The U.S. Food And Drug Although The U.S. Food And Drug Administration (FDA) Set Some GDP Standards, Others Fall Under The Current Good Manufacturing Practice
Objective :To lay down the procedure for Good Documentation Practices in facility. Scope:This standard operating procedure is applicable to all departments involved in documentation activities throughout the facility of Pharmaceutical Company (Name).
Documentation is a key area for companies in the pharmaceutical industry. The United States Food and Drug Administration (FDA )- the governmental agency, that is responsible for overseeing the industry, requires extensive documentation for every manufacturing and packaging lot of all pharmaceutical products. The FDA mandates documentation for the sake of accountability and …
GUEST COLUMN Documentation and Record Maintenance: A Need for Good Manufacturing Practices (GMP) Compliance in Pharma & Healthcare Industry -Zbstract
necessary controls for good documentation practices for electronic data are in place and that the probability of the occurrence of errors in the data is minimized ; • training of personnel who use computerized systems and review electronic data in
• Sustaining Good Documentation Practices. Who Will Be the Next Poster Child Source: Washington Post, Sept 26,2015 3. Background •Data Integrity is “The degree to which a collection of data is complete, consistent, and accurate” Source: FDA Glossary of Computer Systems Software Development Terminology (8/95) •Two main areas of concern regarding data integrity in CGMP …
Current Good Manufacturing Practices Checklist For Pharmaceutical Manufacturers Current Good Manufacturing Practices (“cGMPs” or “GMPs”) for pharmaceutical manufacturers provide the methods and controls used for the manufacturing, processing, packaging or holding of a pharmaceutical to assure that the pharmaceutical meets the minimum safety requirements of the Federal Food, Drug …
Good Manufacturing Practices (GMP) Guidelines for Active Pharmaceutical Ingredients (GUI-0104) Consultation Notice to Stakeholders – Invitation to Participate in a Survey for Canadian Active Pharmaceutical Ingredients (API) Stakeholders [2011-03-25]

Documentation in GMP (Good Manufacturing Practices
Requirements for Good Documentation Practice (GDP

Good Documentation Practices (GDP) is a critical and essential part of a regulated environment (pharmaceutical and medical device manufacturing, R&D, laboratories and clinical trials). Compliance with GDP ensures an auditable account of work. It ensures integrity and control of documents and is a key requirement for a developed quality system.
GUEST COLUMN Documentation and Record Maintenance: A Need for Good Manufacturing Practices (GMP) Compliance in Pharma & Healthcare Industry -Zbstract
Cleaning validation in the pharmaceutical industry has been a topic of ever-increasing interest and scrutiny in recent Food and Drug Administration (FDA) inspections.The validation of procedures used to clean the equipment employed during the various steps of a manufacturing process is a clear requirement of current Good Manufacturing Practice (cGMP). As such, FDA inspectors now expect …
Logistics Good Distribution Practices (GDP) Certification for Pharmaceutical Industry Maintaining product safety and quality during distribution is of utmost importance in the pharmaceutical industry.
260 Introduction to Pharma Current Good Manufacturing Practice (cGMP) is an overview course that examines the basics of current good manufacturing practice (cGMP) in the pharmaceutical industry.
Objective :To lay down the procedure for Good Documentation Practices in facility. Scope:This standard operating procedure is applicable to all departments involved in documentation activities throughout the facility of Pharmaceutical Company (Name).
The Pharmaceutical Quality Group (PQG) was formed in 1977 to promote development of a consistent approach to pharmaceutical quality and good manufacturing practices.
An overview of good documentation practices applicable to those working in the pharmaceutical and healthcare sectors is presented. Discover the world’s research 15 million members
application to laboratory activities, manufacturing good manufacturing practices in pharmaceutical industry ppt and support functions, as well as demonstrate the need for thorough and comprehensive GMP training and documentation.