Good documentation practices
•Download as PPTX, PDF•
0 likes•477 views
The document discusses Good Documentation Practices (GDP) and their importance for regulatory compliance, product quality standards, and certification. It outlines key components of GDP like quality management systems and risk management strategies. The aims of GDP are described as accurate, concise, legible, traceable, contemporaneous, enduring, and accessible documentation. Principles of GDP discussed include never falsifying, destroying, or altering records. Examples provided include documentation of equipment cleaning, raw materials, batch production, and a record keeping system.
Report
Share
Report
Share
Recommended
Good documentation practice
The document provides guidance on good documentation practices for pharmaceutical manufacturing. It discusses the importance of documentation and outlines key requirements for documents and records to ensure data integrity. These include maintaining batch records, equipment cleaning records, raw material records, production instructions, laboratory testing records, and conducting batch record reviews. Documentation must be accurate, contemporaneous, attributable, complete, consistent, enduring and readily available. All activities should be properly documented at the time they are performed and any changes must be justified and traceable. Good documentation practices are necessary to demonstrate compliance and allow for traceability in the pharmaceutical quality system.
Good Documentation Pactise dr. amsavel
This document discusses good documentation practices for GMP compliance. It defines what documentation is, outlines the types of documents required by GMP such as batch records and SOPs. It explains the importance of documentation for meeting legal requirements, business needs, and enabling good decision making. It provides tips for writing good documentation including structure, approvals, version control, and retention. Overall it emphasizes that documentation is critical to demonstrate regulatory compliance and quality.
Good Documentation Practices -Do's and Don'ts- (GCP)
This document provides guidance on good documentation practices. It emphasizes that documentation should be attributable, legible, contemporaneous, original, and accurate. Key points include:
- Documentation is important for regulatory compliance and represents the quality of an organization's work.
- Documentation must clearly show who performed and observed activities and when.
- Original documents should be distinguishable from copies and have clear, concise information.
- Data entries must be made at the time of the activity and any corrections clearly shown.
Good documentation practices
The document provides guidelines for good documentation practices at Opal Laboratories. It is the responsibility of all persons involved in document preparation or review to follow these practices. Key principles include double checking entries for mistakes, ensuring documents are complete before forwarding, treating documentation as essential, writing clearly, using proper procedures for corrections, and documenting all necessary information immediately without relying on memory. The document outlines proper procedures for corrections, use of comments/remarks, blank spaces, missing entries, signatures, ink colors, grammar checks, date entries, final approvals, timely entries, and responsibility for accuracy.
Good documentation practice
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
Good documentation practices are very important for any organization and all of their workers to understand its business ethics and importance.
Good documentation practices
Good Documentation Practice (GDocP — or GRK for Good Recordkeeping) is an essential component of your overall pharmaceutical quality system (PQS) and quality risk management strategies (QRM).
new guidance on good data management was discussed and its development
recommended. The participants included national inspectors and specialists
in the various agenda topics, as well as staff of the Prequalification Team
(PQT)–Inspections
Good Documentation Practice (GDocP).pdf
Good Documentation Practice (GDocP) is an essential part of the quality assurance and such, related to all aspects of GMP” this definition is based on WHO. It is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of document.
Recommended
Good documentation practice
The document provides guidance on good documentation practices for pharmaceutical manufacturing. It discusses the importance of documentation and outlines key requirements for documents and records to ensure data integrity. These include maintaining batch records, equipment cleaning records, raw material records, production instructions, laboratory testing records, and conducting batch record reviews. Documentation must be accurate, contemporaneous, attributable, complete, consistent, enduring and readily available. All activities should be properly documented at the time they are performed and any changes must be justified and traceable. Good documentation practices are necessary to demonstrate compliance and allow for traceability in the pharmaceutical quality system.
Good Documentation Pactise dr. amsavel
This document discusses good documentation practices for GMP compliance. It defines what documentation is, outlines the types of documents required by GMP such as batch records and SOPs. It explains the importance of documentation for meeting legal requirements, business needs, and enabling good decision making. It provides tips for writing good documentation including structure, approvals, version control, and retention. Overall it emphasizes that documentation is critical to demonstrate regulatory compliance and quality.
Good Documentation Practices -Do's and Don'ts- (GCP)
This document provides guidance on good documentation practices. It emphasizes that documentation should be attributable, legible, contemporaneous, original, and accurate. Key points include:
- Documentation is important for regulatory compliance and represents the quality of an organization's work.
- Documentation must clearly show who performed and observed activities and when.
- Original documents should be distinguishable from copies and have clear, concise information.
- Data entries must be made at the time of the activity and any corrections clearly shown.
Good documentation practices
The document provides guidelines for good documentation practices at Opal Laboratories. It is the responsibility of all persons involved in document preparation or review to follow these practices. Key principles include double checking entries for mistakes, ensuring documents are complete before forwarding, treating documentation as essential, writing clearly, using proper procedures for corrections, and documenting all necessary information immediately without relying on memory. The document outlines proper procedures for corrections, use of comments/remarks, blank spaces, missing entries, signatures, ink colors, grammar checks, date entries, final approvals, timely entries, and responsibility for accuracy.
Good documentation practice
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
Good documentation practices are very important for any organization and all of their workers to understand its business ethics and importance.
Good documentation practices
Good Documentation Practice (GDocP — or GRK for Good Recordkeeping) is an essential component of your overall pharmaceutical quality system (PQS) and quality risk management strategies (QRM).
new guidance on good data management was discussed and its development
recommended. The participants included national inspectors and specialists
in the various agenda topics, as well as staff of the Prequalification Team
(PQT)–Inspections
Good Documentation Practice (GDocP).pdf
Good Documentation Practice (GDocP) is an essential part of the quality assurance and such, related to all aspects of GMP” this definition is based on WHO. It is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of document.
Good Documentation Practice (GDP)
The document discusses good documentation practices (GDP) for ensuring auditable records. It covers why GDP is important, what constitutes documentation, the types of documents, regulatory requirements, the documentation life cycle including creation, use, review and archiving. Key aspects of GDP covered include document numbering, signatures, dates, revisions, corrections and reviews. The benefits of good documentation for quality, compliance and regulatory approval are also highlighted.
Good Documentation Practice
This document discusses good documentation practices for quality systems. It emphasizes recording all necessary information immediately and completely, reviewing documentation annually, and maintaining documentation throughout its life cycle. Regulatory bodies like ISO and NABL require documentation for quality assurance. Documentation provides a record, ensures traceability and accountability, and aids in communication. All personnel are responsible for properly preparing, completing, and reviewing documentation according to basic principles like using permanent ink and not erasing mistakes.
GDP Training NS
This document outlines good documentation practices for cGMP documents. It states that all documents produced by a company may be reviewed by regulatory agencies. It provides guidelines for writing in cGMP documents, such as using blue ink and initialing and dating all entries. It describes types of cGMP documents and proper ways to record information, make corrections, document deviations, and void or recreate records. The overall purpose is to ensure strict documentation rules are followed to maintain compliance with regulatory agencies.
Good documentation practice
The document provides guidelines for good documentation practices at a company. It states that the purpose is to standardize ways to correct errors in documentation. All persons involved in preparing, completing or reviewing documents are responsible for following these practices. This includes checking for mistakes, ensuring documents are complete before forwarding, treating documentation as important rather than an inconvenience, writing clearly, and only the person responsible should correct errors. Proper documentation is important for traceability and accountability.
Good documentation practices
Sushant Sardana's objective is to raise awareness of the importance of documentation for pharmaceutical and healthcare products. Good documentation practices (GDP) are required by law and regulations to demonstrate compliance and provide an audit trail. GDP help ensure documentation is permanent, legible, accurate, prompt, clear, consistent, complete, direct, and truthful. Major errors in documentation must be properly corrected and explained. If an activity is not documented, it did not happen according to regulatory standards.
Good Documentation Practices
This document discusses good documentation practices (GDP) in the pharmaceutical industry. GDP describes standards for creating and maintaining documentation to ensure regulatory compliance, customer requirements are met, and documentation errors do not cause safety, legal or regulatory issues. Proper GDP is important as documentation serves as an advertisement of how committed and sincere a company is. GDP covers documentation for various organizational functions and requires documentation be permanent, legible, accurate, prompt, clear, consistent, complete, direct, truthful, current and traceable. The document outlines specific standards and steps for GDP including proper recording, corrections, signatures and reviews.
GMP - GOOD DOCUMENTATION PRACTICES
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical industry to describe standards by which documents are created and maintained. While some GDocP standards are codified by various competent authorities, others are not but are considered cGMP (with emphasis on the "c", or "current"). Some competent authorities release or adopt guidelines, and they may include non-codified GDocP expectations. While authorities will inspect against these guidelines and cGMP expectations in addition to the legal requirements and make comments or observations if departures are seen. In the past years, the application of GDocP is also expanding to cosmetic industry, excipient and ingredient manufacturers.
good documentation practice
This document discusses Good Documentation Practices (GDP) which are an essential part of quality assurance according to WHO. GDPs apply to anyone documenting cGMP activities. Key aspects of GDP include ensuring documentation is true, accurate, timely and legible. Documents that require following GDP include batch records, standard operating procedures, validation documents, and quality records. Signatures on GMP documents confirm identity and responsibility. Documentation serves to define specifications and procedures, ensure regulatory compliance, and provide an audit trail. Basic GDP requirements include contemporaneous recording, signatures and dates, use of English, no corrections, and no backdating.
GDP-PPT (1).pptx
This document discusses good documentation practices. It defines good documentation as accurately recording all activities so there is documented evidence of what was done. It emphasizes that documentation is essential for quality assurance and regulatory compliance. The document outlines standards for documentation including contemporaneous record keeping, approvals, signatures, revisions, retention, and review. It describes typical elements of a documentation system and different types of documents.
Good Documentation Practices
Basic Principle of GDocP, Good Documentation Practices, ALCOA, ALCOA+, MHRA and Eudralex Guidlines, Effective GDocP, Common GDocP errors, Benefits of GDocP, GDocP Improvement, GMP, Pharmaceutical
Good Documentation Practice
Good Documentation Practice is important to ensure activities are properly documented. GDP defines documents as instructions that guide how activities are executed, while records provide evidence activities were performed. Documentation must be accurate, concise, legible, traceable, contemporaneous, enduring and accessible. It is important to never falsify, obliterate or improperly correct information in records. All activities should be fully documented at the time they are performed. Reviews are necessary to check for completeness and compliance. Maintaining proper documentation is important for regulatory compliance, building confidence, meeting requirements, and solving problems.
Good Documentation Practice
This document from the United States Army Medical Research Institute of Chemical Defense provides guidance on Good Documentation Practices (GDP) for ensuring reliable, consistent documentation in research. It outlines specifics of GDP such as making legible data entries immediately, using indelible ink and explaining abbreviations. It also describes how to properly make and document corrections to records as well as how to maintain accuracy, clarity and traceability. Examples of bad documentation practices that should be avoided are given at the end.
Gdp alcoa
This document discusses data integrity and good documentation practices. It begins with an introduction to the ALCOA principles for data quality, which stand for Attributable, Legible, Contemporaneous, Original, and Accurate. It then defines data integrity and lists some common data integrity issues seen by regulators. The rest of the document outlines good documentation practices, including the importance of conforming to standards, maintaining document versions and revisions, and avoiding issues like undocumented changes. It emphasizes that poor documentation can undermine drug safety and efficacy and break regulatory trust.
Good documentation practices
This document discusses good documentation practices for the pharmaceutical industry. It explains that documentation needs to meet certain standards to ensure product quality and safety. Poor documentation can negatively impact manufacturing and quality assurance, potentially reducing patient safety. The regulations from PIC/S, FDA, and EU all include mandatory sections on documentation, as it provides information on tasks and evidence that tasks were completed properly. Following good documentation standards can help companies successfully manufacture quality, safe products and improve audit outcomes.
1 documents & Requirements
ICH Q7A GMP Guidance For API .Good Documentation Practices.Why Documentation is required..? To define the method and control. GOOD DOCUMENTATION PRACTICE
Good Documentation Practice (GDP)
This slide is related to Good documentation Practice in Pharmaceutical Industries. It was presented in the pharmaceutical industry (Chemidrug Industry Private Ltd.) during the training session.
Good Documentation Practices
This presentation will cover all aspects of GDP as per the proposal in the Proposed USP–NF General Chapter <1029>.
Good documentation practice
This document defines key terms related to documentation practices for Good Manufacturing Practices (GMP) and outlines the principles and types of documents required by GMP. It discusses documentation requirements for laboratories, equipment, deviations, batch records, certificates of analysis, standard operating procedures, protocols, training, and retention of documents. The key aspects of GMP documentation are that it must be attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available.
Data integrity & ALCOA+
Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archival, retrieval, transmission, and disposition of data after the record’s retention period ends. It would be helpful for data management.
Gdp alcoa-160229041605-converted
This document provides information on good documentation practices (GDP) for pharmaceutical manufacturing. It discusses how documentation is crucial for quality assurance and aims to ensure manufacturing processes are carried out consistently as planned. It defines key terms like documents, records, data reliability and integrity. The document outlines good practices for documentation like contemporaneous recording, error correction procedures, and preventing issues like falsification. It provides examples of documentation deficiencies from inspections and consequences of poor practices like warning letters. Maintaining ALCOA principles of documentation - being Attributable, Legible, Contemporaneous, Original and Accurate - is emphasized. Case studies on meningitis and salmonella outbreaks show how documentation lapses can have severe public health impacts.
2014 ne conference presentation by rick calabrese
This document outlines objectives and requirements for establishing quality standards for non-regulated biomedical research in drug development. It aims to ensure reliable data generation to support investment decisions. Key points include establishing management systems, documentation procedures, technical requirements for personnel, facilities, equipment and calibration, validated test methods, and consideration of legal and ethical issues. The overall goal is to minimize waste and improve productivity in the drug development process.
GLP in Bioequivalence Studies
This document discusses the role of GLP compliance in generating accurate and reproducible bioequivalence data. It provides an overview of the evolution of GLP guidelines and the key fundamentals of GLP, including resources, rules and procedures, test characterization, documentation, and quality assurance. It notes that while BE studies involve human subjects and must comply with GCP, the analytical laboratory work should also adhere to GLP principles. Key regulatory guidelines on applying GLP to bioanalytical methods from the US FDA, EMEA, and ICH are summarized. Maintaining both GCP and GLP compliance through validated methods, quality systems, training and oversight can help ensure the best BE study results and regulatory acceptance.
More Related Content
What's hot
Good Documentation Practice (GDP)
The document discusses good documentation practices (GDP) for ensuring auditable records. It covers why GDP is important, what constitutes documentation, the types of documents, regulatory requirements, the documentation life cycle including creation, use, review and archiving. Key aspects of GDP covered include document numbering, signatures, dates, revisions, corrections and reviews. The benefits of good documentation for quality, compliance and regulatory approval are also highlighted.
Good Documentation Practice
This document discusses good documentation practices for quality systems. It emphasizes recording all necessary information immediately and completely, reviewing documentation annually, and maintaining documentation throughout its life cycle. Regulatory bodies like ISO and NABL require documentation for quality assurance. Documentation provides a record, ensures traceability and accountability, and aids in communication. All personnel are responsible for properly preparing, completing, and reviewing documentation according to basic principles like using permanent ink and not erasing mistakes.
GDP Training NS
This document outlines good documentation practices for cGMP documents. It states that all documents produced by a company may be reviewed by regulatory agencies. It provides guidelines for writing in cGMP documents, such as using blue ink and initialing and dating all entries. It describes types of cGMP documents and proper ways to record information, make corrections, document deviations, and void or recreate records. The overall purpose is to ensure strict documentation rules are followed to maintain compliance with regulatory agencies.
Good documentation practice
The document provides guidelines for good documentation practices at a company. It states that the purpose is to standardize ways to correct errors in documentation. All persons involved in preparing, completing or reviewing documents are responsible for following these practices. This includes checking for mistakes, ensuring documents are complete before forwarding, treating documentation as important rather than an inconvenience, writing clearly, and only the person responsible should correct errors. Proper documentation is important for traceability and accountability.
Good documentation practices
Sushant Sardana's objective is to raise awareness of the importance of documentation for pharmaceutical and healthcare products. Good documentation practices (GDP) are required by law and regulations to demonstrate compliance and provide an audit trail. GDP help ensure documentation is permanent, legible, accurate, prompt, clear, consistent, complete, direct, and truthful. Major errors in documentation must be properly corrected and explained. If an activity is not documented, it did not happen according to regulatory standards.
Good Documentation Practices
This document discusses good documentation practices (GDP) in the pharmaceutical industry. GDP describes standards for creating and maintaining documentation to ensure regulatory compliance, customer requirements are met, and documentation errors do not cause safety, legal or regulatory issues. Proper GDP is important as documentation serves as an advertisement of how committed and sincere a company is. GDP covers documentation for various organizational functions and requires documentation be permanent, legible, accurate, prompt, clear, consistent, complete, direct, truthful, current and traceable. The document outlines specific standards and steps for GDP including proper recording, corrections, signatures and reviews.
GMP - GOOD DOCUMENTATION PRACTICES
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical industry to describe standards by which documents are created and maintained. While some GDocP standards are codified by various competent authorities, others are not but are considered cGMP (with emphasis on the "c", or "current"). Some competent authorities release or adopt guidelines, and they may include non-codified GDocP expectations. While authorities will inspect against these guidelines and cGMP expectations in addition to the legal requirements and make comments or observations if departures are seen. In the past years, the application of GDocP is also expanding to cosmetic industry, excipient and ingredient manufacturers.
good documentation practice
This document discusses Good Documentation Practices (GDP) which are an essential part of quality assurance according to WHO. GDPs apply to anyone documenting cGMP activities. Key aspects of GDP include ensuring documentation is true, accurate, timely and legible. Documents that require following GDP include batch records, standard operating procedures, validation documents, and quality records. Signatures on GMP documents confirm identity and responsibility. Documentation serves to define specifications and procedures, ensure regulatory compliance, and provide an audit trail. Basic GDP requirements include contemporaneous recording, signatures and dates, use of English, no corrections, and no backdating.
GDP-PPT (1).pptx
This document discusses good documentation practices. It defines good documentation as accurately recording all activities so there is documented evidence of what was done. It emphasizes that documentation is essential for quality assurance and regulatory compliance. The document outlines standards for documentation including contemporaneous record keeping, approvals, signatures, revisions, retention, and review. It describes typical elements of a documentation system and different types of documents.
Good Documentation Practices
Basic Principle of GDocP, Good Documentation Practices, ALCOA, ALCOA+, MHRA and Eudralex Guidlines, Effective GDocP, Common GDocP errors, Benefits of GDocP, GDocP Improvement, GMP, Pharmaceutical
Good Documentation Practice
Good Documentation Practice is important to ensure activities are properly documented. GDP defines documents as instructions that guide how activities are executed, while records provide evidence activities were performed. Documentation must be accurate, concise, legible, traceable, contemporaneous, enduring and accessible. It is important to never falsify, obliterate or improperly correct information in records. All activities should be fully documented at the time they are performed. Reviews are necessary to check for completeness and compliance. Maintaining proper documentation is important for regulatory compliance, building confidence, meeting requirements, and solving problems.
Good Documentation Practice
This document from the United States Army Medical Research Institute of Chemical Defense provides guidance on Good Documentation Practices (GDP) for ensuring reliable, consistent documentation in research. It outlines specifics of GDP such as making legible data entries immediately, using indelible ink and explaining abbreviations. It also describes how to properly make and document corrections to records as well as how to maintain accuracy, clarity and traceability. Examples of bad documentation practices that should be avoided are given at the end.
Gdp alcoa
This document discusses data integrity and good documentation practices. It begins with an introduction to the ALCOA principles for data quality, which stand for Attributable, Legible, Contemporaneous, Original, and Accurate. It then defines data integrity and lists some common data integrity issues seen by regulators. The rest of the document outlines good documentation practices, including the importance of conforming to standards, maintaining document versions and revisions, and avoiding issues like undocumented changes. It emphasizes that poor documentation can undermine drug safety and efficacy and break regulatory trust.
Good documentation practices
This document discusses good documentation practices for the pharmaceutical industry. It explains that documentation needs to meet certain standards to ensure product quality and safety. Poor documentation can negatively impact manufacturing and quality assurance, potentially reducing patient safety. The regulations from PIC/S, FDA, and EU all include mandatory sections on documentation, as it provides information on tasks and evidence that tasks were completed properly. Following good documentation standards can help companies successfully manufacture quality, safe products and improve audit outcomes.
1 documents & Requirements
ICH Q7A GMP Guidance For API .Good Documentation Practices.Why Documentation is required..? To define the method and control. GOOD DOCUMENTATION PRACTICE
Good Documentation Practice (GDP)
This slide is related to Good documentation Practice in Pharmaceutical Industries. It was presented in the pharmaceutical industry (Chemidrug Industry Private Ltd.) during the training session.
Good Documentation Practices
This presentation will cover all aspects of GDP as per the proposal in the Proposed USP–NF General Chapter <1029>.
Good documentation practice
This document defines key terms related to documentation practices for Good Manufacturing Practices (GMP) and outlines the principles and types of documents required by GMP. It discusses documentation requirements for laboratories, equipment, deviations, batch records, certificates of analysis, standard operating procedures, protocols, training, and retention of documents. The key aspects of GMP documentation are that it must be attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available.
Data integrity & ALCOA+
Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archival, retrieval, transmission, and disposition of data after the record’s retention period ends. It would be helpful for data management.
Gdp alcoa-160229041605-converted
This document provides information on good documentation practices (GDP) for pharmaceutical manufacturing. It discusses how documentation is crucial for quality assurance and aims to ensure manufacturing processes are carried out consistently as planned. It defines key terms like documents, records, data reliability and integrity. The document outlines good practices for documentation like contemporaneous recording, error correction procedures, and preventing issues like falsification. It provides examples of documentation deficiencies from inspections and consequences of poor practices like warning letters. Maintaining ALCOA principles of documentation - being Attributable, Legible, Contemporaneous, Original and Accurate - is emphasized. Case studies on meningitis and salmonella outbreaks show how documentation lapses can have severe public health impacts.
What's hot (20)
Similar to Good documentation practices
2014 ne conference presentation by rick calabrese
This document outlines objectives and requirements for establishing quality standards for non-regulated biomedical research in drug development. It aims to ensure reliable data generation to support investment decisions. Key points include establishing management systems, documentation procedures, technical requirements for personnel, facilities, equipment and calibration, validated test methods, and consideration of legal and ethical issues. The overall goal is to minimize waste and improve productivity in the drug development process.
GLP in Bioequivalence Studies
This document discusses the role of GLP compliance in generating accurate and reproducible bioequivalence data. It provides an overview of the evolution of GLP guidelines and the key fundamentals of GLP, including resources, rules and procedures, test characterization, documentation, and quality assurance. It notes that while BE studies involve human subjects and must comply with GCP, the analytical laboratory work should also adhere to GLP principles. Key regulatory guidelines on applying GLP to bioanalytical methods from the US FDA, EMEA, and ICH are summarized. Maintaining both GCP and GLP compliance through validated methods, quality systems, training and oversight can help ensure the best BE study results and regulatory acceptance.
Standard operating procedure in pharmaceutical industries,SOP,MFR,Master Form...
This presentation deals with Standard operating procedure in pharmaceutical industries.
Simran Kukreja
M. Pharm. (Pharmaceutics)
good documentation practice
Good documentation practice
Introduction
What types of documents require to follow Good Documentation Practices?
Meaning of signature
Purpose of documentation
Basic requirements of GDP
Preparation of documents
Cancellation of GMP records
reference
• Analytical Methods
• Policies
• Batch Records
• Protocols
• Bills of Materials (BOMs)
• Test Methods
• Certificate of Analyses (CoA)
• Training
Documentation
• Certificate of Compliance (CoC)
• Logbooks
• Laboratory Notebooks
• Calibration records
• Quality records - non-conformances
- CAPAs
- internal inspection reports
- change control
Best Quality Practices for Biomedic Research: Rick Calabrese ASQ 2014 NE Conf...
The document outlines best quality practices for biomedical research in drug development. It discusses establishing quality standards for non-regulated research to ensure validity and integrity of data. The technical report specifies general quality requirements covering areas like management systems, documentation, personnel training, facilities, equipment calibration and test methods. The goal is to minimize waste and costs by generating reliable data to support drug development decisions.
GLP Good Laboratory Practices Presentati
The document discusses Good Laboratory Practices (GLP), which are regulations created by the FDA in 1978 that provide a framework for conducting laboratory studies. GLP aims to ensure data submitted to regulatory authorities is accurate and traceable. The FDA investigation of laboratories in the 1970s uncovered fraudulent activities and poor practices that led to the creation of GLP. Key aspects of GLP include standard operating procedures, personnel qualifications, facility organization, equipment validation and maintenance of complete records. Noncompliance with GLP can result in the disqualification of a testing facility.
GLP.pdf
The fundamental purposes of the Principles of Good Laboratory Practice (GLP) is to ensure the quality and integrity of test data related to non-clinical safety studies.
Presentation for good documentary practices revised shravan
1. The document discusses good documentation practices for quality assurance and quality systems. It outlines the key elements of quality systems and 10 commandments for good manufacturing practices.
2. It defines key quality terms like GxP, defines what a document is, and explains the regulatory expectations around documentation being concise, legible, accurate and traceable.
3. The document emphasizes that documentation is important for demonstrating regulatory compliance, avoiding observations, and ensuring safe and effective medicines are produced. It provides guidance on fundamental document types, practices for document control, and the importance of high quality documentation.
GLP FINAL.pptx
The Principles of Good Laboratory Practice (GLP) are a managerial quality control system covering the organisational process and the conditions under which non-clinical health and environmental studies are planned, performed, monitored, recorded, reported and retained (or archived). The OECD Principles of GLP are followed by test facilities carrying out studies to be submitted to receiving authorities for the purposes of assessing the health and environmental safety of chemicals and chemical products which may also be of natural or biological origin and, in some circumstances, may be living organisms.
The Principles of GLP define the responsibilities of test facility management, study director, study personnel and quality assurance personnel that are operating within a GLP system, and minimum standards concerning the suitability of facilities and equipment to perform studies, the need for standard operating procedures, documentation of raw data, study reports, the archiving of records, etc.
presentationforgooddocumentarypracticesrevisedshravan-150912105000-lva1-app68...
Good documentation practices are essential for quality assurance. The key elements of a quality system include management principles, personnel, documentation, facilities, material and product control, process assurance, and incident management. The "10 Commandments of GMP" establish best practices for writing procedures, following procedures, documenting work, designing facilities, maintaining equipment, validating processes, maintaining cleanliness, ensuring competence, controlling quality, and conducting audits. Proper document practices include generating concise, legible, accurate, and traceable records to demonstrate regulatory compliance and support quality operations.
Standard operating procedure in pharmaceutical industries rashmi nasare
standard operating procedure is the type of document which is used in reference copy for batch manufacturing record & master production records.
Expectations from regulatory authorities
This document discusses expectations from regulatory authorities for chemical testing laboratories. It covers the key regulatory bodies of the Food and Drug Administration (FDA) and the National Accreditation Board for Testing and Calibration Laboratories (NABL). The FDA ensures drugs and cosmetics meet quality standards, while NABL provides laboratory accreditation and certification based on ISO standards. Accreditation enhances customer confidence and satisfaction. Both authorities require laboratories to follow quality standards and procedures for calibration, documentation, method validation, trained personnel, and more. The document outlines responsibilities and technical requirements to comply with FDA and NABL expectations.
Presentation1.pptx final
The document provides information on documentation in the pharmaceutical industry including:
1. It emphasizes the importance of documentation for industries and describes protocols regarding documentation and their management.
2. Documentation is the key to GMP compliance and ensures traceability of all development, manufacturing, and testing activities. It provides a route for auditors to assess quality operations.
3. The most common types of documents used for GMP are described, including quality manuals, standard operating procedures, batch records, test methods, and specifications.
GLP Medha tiwari
In this slide ,explain about GLP I.e Good Laboratories Practices to safe environments ,human and animal health. Which is apply to all laboratories, Pharmaceutical and Cosmetic Industries, Universities etc.Described about different points like 5S,Cleaning,Documentation,Calibration Handling, Training,Induction Precautions,Safety,Hygiene , Test system, Standard Operating Procedure I.e “SOP”etc. According to OECD and WHO guidelines must be followed GLP . Also describe about D&C act and rules 1945. GLP is explain in schedule T of D&C act for Ayurvedic, Siddha and Unani Medicine.
GLP .pptx
GLP (Good Laboratory Practices) are quality standards for designing, conducting, recording, and reporting non-clinical research studies that ensure data integrity and reproducibility. GLP requirements in India are mentioned in Schedule L-1 of the Drugs and Cosmetics Act. The FDA created GLP regulations in 1978 after cases of poor laboratory practices compromised pre-clinical safety data. GLP principles apply to manufacturing laboratories, government laboratories, and universities conducting non-clinical studies. Key aspects of GLP include requirements for personnel, facilities, equipment, test substances, storage, safety precautions, and documentation and record-keeping practices.
Good Laboratory Practices ppt
GLP is a formal FDA regulation created in 1978 that provides principles for conducting laboratory studies in a standard, consistent manner. It aims to ensure quality and integrity of data submitted to the FDA. Key GLP principles include requirements for test facility organization, quality assurance programs, facilities, equipment, test systems, standard operating procedures, study conduct, reporting, and record keeping. GLP helps provide reliable results and protects study integrity and data for regulating products like drugs and pesticides.
Good Laboratory Practices (http://www.ubio.in)
The document discusses Good Laboratory Practice (GLP), which refers to a quality system for non-clinical safety studies. It outlines the history and regulations around GLP from agencies like the FDA and OECD. Key aspects of GLP include establishing a quality assurance unit, appointing a study director, using standard operating procedures and calibrated equipment, qualified personnel, documentation, auditing, and archiving materials. GLP is meant to ensure the quality and validity of non-clinical safety studies.
Good laboratory practices
This document provides an overview of Good Laboratory Practices (GLP). It discusses that GLP aims to assure regulatory authorities that safety study data submitted to them are reliable and accurate. The document traces the history and development of GLP from cases of poor laboratory practices in the 1970s. It describes the key principles of GLP including requirements for facilities, equipment, test systems, personnel responsibilities, standard operating procedures, and reporting of study results. Adherence to GLP aims to produce high quality and integrity of nonclinical safety data.
Good manufacturing practices & standard operating procedure
Prepared BY- Ruhid Hasan
from:- University of Development Alternative
dept. of Pharmacy [Life Scince]
Unit 02 chapter 05 documentation systems documents and record keeping
This document discusses documentation and record keeping requirements for quality management systems. It covers the key principles of documentation including accuracy, integrity and availability. It describes the types of documents and records required such as specifications, manufacturing instructions, certificates and reports. The document provides details on EU GMP chapter 4 requirements for documentation practices, document control, record retention and approval. It emphasizes that a documentation system is essential to meet regulatory standards and continual improvement.
Similar to Good documentation practices (20)
Standard operating procedure in pharmaceutical industries,SOP,MFR,Master Form...
Standard operating procedure in pharmaceutical industries,SOP,MFR,Master Form...
Best Quality Practices for Biomedic Research: Rick Calabrese ASQ 2014 NE Conf...
Best Quality Practices for Biomedic Research: Rick Calabrese ASQ 2014 NE Conf...
Presentation for good documentary practices revised shravan
Presentation for good documentary practices revised shravan
presentationforgooddocumentarypracticesrevisedshravan-150912105000-lva1-app68...
presentationforgooddocumentarypracticesrevisedshravan-150912105000-lva1-app68...
Standard operating procedure in pharmaceutical industries rashmi nasare
Standard operating procedure in pharmaceutical industries rashmi nasare
Good manufacturing practices & standard operating procedure
Good manufacturing practices & standard operating procedure
Unit 02 chapter 05 documentation systems documents and record keeping
Unit 02 chapter 05 documentation systems documents and record keeping
More from Imdad H. Mukeri
Design of Experiments (DOE)
The document discusses the use of design of experiments (DoE) in pharmaceutical development. It begins with an introduction to DoE, covering its history, terminology, why and how it is used. The document then discusses the types of DoE including factorial designs and fractional factorial designs. Examples of DoE applications in areas like oral drug delivery and inhalation drug delivery are provided. The advantages of DoE include maximizing process knowledge with minimal resources and establishing cause-and-effect relationships. The document concludes that DoE is a useful statistical tool that can promote quality in pharmaceutical development.
Quiz questions For class 6,7,8,9,10.pptx
The document describes an ACS chemistry festival quiz competition for school students organized by IMDAD H. MUKERI. It provides the rules and regulations of the quiz including that it is a team-based competition with 4 members per group, no negative marking, use of mobile devices is not allowed, questions will be in multiple choice format, and each group will get 8 questions to answer within 1 minute per question. It then provides 24 multiple choice questions as sample questions that may be asked in the quiz competition covering various topics in chemistry, general knowledge, and current affairs.
Bioavailability of Gold nanoparticles.pptx
Gold nanoparticles (AuNPs) are the most stable metal nanoparticles, also called Gold Colloidal nanomaterials that have quasi-dynamic nature.
Their properties include high stability, high surface area, good conductivity, and low toxicity and biocompatibility Useful in biological applications.
BCS Guideline for solubility and Dissolution.pptx
Briefly explanation of The Biopharmaceutics Classification System (BCS) of drug substance
and its solubility in the pH range of 1–7.5, absorption or intestinal membrane permeability
Analytical Method Development and validation of UV-Visible spectroscopy
Method Development and validation, UV-Visible spectroscopy, wavelength 257 nm, method are accurate, precise, specified, and validated
Electrophoresis
This document provides information about electrophoresis. It begins with an acknowledgment and table of contents. Then it provides definitions and explanations of electrophoresis, including that it involves the migration of charged particles under an electric field. It discusses factors that affect electrophoresis like electric field strength. It also describes the basic instrumentation, including apparatus, power supply, and reagents like agarose gel, buffer solutions and dyes. Finally, it explains different electrophoresis techniques like paper, capillary and gel electrophoresis, focusing on gel electrophoresis and its uses and procedures.
Biosensor technology
This document discusses biosensor technology. It defines biosensors as devices that sense and analyze biological information and convert it into an electrical signal. The document outlines various types of biosensors and their applications, including use in medical diagnosis, industrial monitoring, clinical analysis, pollution monitoring, and more. It concludes that biosensor technology is still emerging but has great potential to lower healthcare costs while maintaining quality of care.
Calibration of Analytical instrument
This document discusses calibration of instruments. It defines calibration as comparing a test instrument to a more precise standard to determine any errors. Calibration is important for accurate measurements and maintaining traceability. There are three main types of calibration: electro-technical, non-electrical, and on-site calibration. Calibration management systems require unique identification of instruments, calibration procedures and schedules, standards traceable to national standards, and trained personnel. Calibration helps minimize errors and ensure accurate quality control and dispute resolution.
Herbals as a materials
This document discusses herbs and herbal medicine. It defines herbs, herbal materials, herbal preparations, finished herbal products, herbal medicines, and herbal medicinal products. Herbal materials include fresh juices, gums, oils, essential oils, resins and dried powders from herbs. Herbal preparations are used to create finished herbal products and can include extracts, tinctures and oils from herbal materials. Finished herbal products contain one or more herbal preparations from single or multiple plants. The document also discusses herbal drug preparation and concludes that natural herbal products have played an important role in improving human health.
Cholera and SARS
The document discusses cholera, which is an acute enteric infection caused by ingesting water or food contaminated with the bacterium Vibrio cholerae. It can lead to severe dehydration and death if left untreated. Prevention involves providing access to clean water and sanitation as well as promoting good hygiene practices. Symptoms of cholera include diarrhea, vomiting, and leg cramps. Treatment focuses on oral rehydration therapy to replace fluids and electrolytes lost from diarrhea.
Radioimmune assay
The document describes radioimmune assay (RIA), a technique developed in 1959 for measuring hormone levels in plasma. RIA uses radioactive tracers, antibodies, and analytes (the substance being measured) to detect very small quantities as low as trillionths of a gram. It works by having a labeled analyte compete with unlabeled analyte in a sample for binding to antibodies. The amount of labeled analyte bound can then indicate the concentration of unlabeled analyte present. RIA is useful for quantifying hormones, drugs, antigens, and other substances in biological fluids. It provides high sensitivity, specificity, and an indirect method of analysis.
Monoclonal antibodies
Monoclonal antibodies are antibodies that are produced by a single clone of cells and have identical binding sites. This document discusses the production of monoclonal antibodies through hybridoma technology, where antibody-producing B cells are fused with myeloma cells. It also summarizes the various applications of monoclonal antibodies in diagnostics, imaging, therapy, and purification. Monoclonal antibodies can be specifically targeted to antigens on cancer cells, delivering toxic drugs directly to tumors while sparing normal cells. Their high specificity makes them useful research and medical tools.
herbals cosmetics
This document provides information about herbal cosmetics. It discusses how herbal cosmetics are formulated using permissible cosmetic ingredients and herbal ingredients to provide defined cosmetic benefits. The document includes sections on the definition of herbal cosmetics, herbal extracts for cosmetics, sources and descriptions of common Indian herbal materials used in cosmetics like amla, brahmi, and neem. It also discusses the types of herbal cosmetics according to application site, advantages and disadvantages of herbal cosmetics, common antioxidants used like vitamin C and E, and examples of herbal ingredients used in skin and hair care like coconut oil, sunflower oil, and aloe vera
herba as raw materials
content material has authentical and aproval valuable.content has been colletect from different book, paper, and article also
Chicory presentation
content was collected from different book, paper, and article .so it has been effective and valuable.my professor also aproved.
More from Imdad H. Mukeri (15)
Analytical Method Development and validation of UV-Visible spectroscopy
Analytical Method Development and validation of UV-Visible spectroscopy
Recently uploaded
share - Lions, tigers, AI and health misinformation, oh my!.pptx
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptx
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.REGULATION FOR COMBINATION PRODUCTS AND MEDICAL DEVICES.pptx
It includes regulation of combination products and medical devices. FDA and industry liaisons.
Artificial Intelligence Symposium (THAIS)
Artificial Intelligence Symposium (THAIS). Parc Taulí. Sabadell
Efficacy of Avartana Sneha in Ayurveda
Avartana Sneha is a unique method of Preparation of Sneha Kalpana in Ayurveda, mainly it is indicated for the Vataja rogas.
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotes
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
Top Effective Soaps for Fungal Skin Infections in India
Swisschem Dermacare has mentioned the List of The Best Antifungal Soap In India 2022. All of these soaps are trusted by various Dermatology Experts.
Role of Mukta Pishti in the Management of Hyperthyroidism
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by Stamler, Verified Chapters 1 - 33, Complete Newest Version Community Health Nursing A Canadian Perspective, 5th Edition by Stamler, Verified Chapters 1 - 33, Complete Newest Version Community Health Nursing A Canadian Perspective, 5th Edition by Stamler Community Health Nursing A Canadian Perspective, 5th Edition TEST BANK by Stamler Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Pdf Chapters Download Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Pdf Download Stuvia Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Study Guide Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Ebook Download Stuvia Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Questions and Answers Quizlet Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Studocu Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Quizlet Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Pdf Chapters Download Community Health Nursing A Canadian Perspective, 5th Edition Pdf Download Course Hero Community Health Nursing A Canadian Perspective, 5th Edition Answers Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Ebook Download Course hero Community Health Nursing A Canadian Perspective, 5th Edition Questions and Answers Community Health Nursing A Canadian Perspective, 5th Edition Studocu Community Health Nursing A Canadian Perspective, 5th Edition Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Pdf Chapters Download Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Pdf Download Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Study Guide Questions and Answers Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Ebook Download Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Questions Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Studocu Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Stuvia
Recently uploaded (20)
share - Lions, tigers, AI and health misinformation, oh my!.pptx
share - Lions, tigers, AI and health misinformation, oh my!.pptx
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptx
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptx
REGULATION FOR COMBINATION PRODUCTS AND MEDICAL DEVICES.pptx
REGULATION FOR COMBINATION PRODUCTS AND MEDICAL DEVICES.pptx
Muscles of Mastication by Dr. Rabia Inam Gandapore.pptx
Muscles of Mastication by Dr. Rabia Inam Gandapore.pptx
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotes
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotes
Top Effective Soaps for Fungal Skin Infections in India
Top Effective Soaps for Fungal Skin Infections in India
Role of Mukta Pishti in the Management of Hyperthyroidism
Role of Mukta Pishti in the Management of Hyperthyroidism
Ear and its clinical correlations By Dr. Rabia Inam Gandapore.pptx
Ear and its clinical correlations By Dr. Rabia Inam Gandapore.pptx
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...
Good documentation practices
- 1. Shalom Institute of Health and Allied Sciences, Shuats Prayagraj,U.P,India Good Documentation practices Submitted to: Prof. Dr. pmalai rajan (Hod, Department of pharmaceutical sciences, SIHAS, SHUATS, Prayagraj, U.P, India) Date of submission: 17/11/2020 Submitted By: Name: Imdad Husen Mukeri Bachelor of pharmacy (7th sem) Id No. 17BPH084 Subject: instrumental method of analysis (701P) 1 5/15/2021 DOPs, SIHAS, SHUATS, Prayajraj, U.P,India
- 2. Introduction to GDocP • Good documentation practices are key components of GMP compliance. • Good record-keeping not only helps you during regulatory inspections (GMP audits), it is mandatory to ensure your documentation practices and your products meet industry standards and legal requirements for safety, efficacy and product quality. • Good documentation practices are also essential for attaining ISO-9001- 2015 certification and other industry-specific ISO certifications specific to your industry, e.g. ISO/IEC 17025 (for laboratory testing and calibration standards) Essential component OF GDocP (not GDP) or DRK 1. Quality management systems (QMS) 2. Risk management strategies (QRM). 2 5/15/2021 DOPs, SIHAS, SHUATS, Prayajraj, U.P,India
- 3. Aim and purpose of good documentation practices (GDocP) • Accurate : true / precise, error free, • Concise: short & clear information that is understood by all • Legible: shall be readable , understandable. • Traceable: who recorded it, where, when and how • Contemporaneous: documented at the time activity done • Enduring: Long lasting and durable • Accessible: Easily available / retrievable 3 5/15/2021 DOPs, SIHAS, SHUATS, Prayajraj, U.P,India
- 4. Principles of GDocP • A document with original signatures should never be destroyed. • Never falsify information • Never do white-out and cover-over-tapes • Never obliterate information or record • Never over-write a record. • Never use pencil – use permanent ink for writing • No spaces, lines or fields are to be left blank • Never use symbols e.g. ditto marks or arrows to indicate repetitive and consecutive entry 4 5/15/2021 DOPs, SIHAS, SHUATS, Prayajraj, U.P,India
- 5. DOCUMENTATION AND RECORDS • Documentation System and Specifications • Equipment Cleaning and Use Record • Records of Raw Materials, Intermediates, API Labeling and Packaging Materials • Batch Production and Control Records • Laboratory control records Record Keeping System • Bound notebook pre-numbered • loose sheets (Pre-numbered, the printing have to be controlled and also the storage as control records) Every register Forms shall have • Format / control number / header • Date of opening • Date of closing • Table of content where applicable 5 5/15/2021 DOPs, SIHAS, SHUATS, Prayajraj, U.P,India
- 6. Example of GDocP 6 5/15/2021 DOPs, SIHAS, SHUATS, Prayajraj, U.P,India
- 7. • Conclusion: In above assignment, I have study about Good Documentation practices. • References: https://www.pharmout.net/good- documentation-practices-gdocp-gmp/(accessed on 15/11/2020) 2) https://www.slideshare.net/DrAmsavelvel/good- documentation-practice-88810012 (accessed on 15/11/2020) 7 5/15/2021 DOPs, SIHAS, SHUATS, Prayajraj, U.P,India