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.
This document discusses pharmaceutical documentation. It defines documentation and its aims which include defining specifications, procedures, and ensuring authorized persons have necessary information. There are different types of documentation like policy documents, specifications, procedures, work instructions, and records. The document also outlines the documentation process including preparation, review, approval, distribution and revision. It describes how mistakes are corrected in documentation and concludes that documentation provides a basis for planning future manufacturing functions in a GMP environment.
This document discusses documentation in the pharmaceutical industry. It defines documentation as the process of systematically recording information about people, events, and documents to create organizational records. Good documentation is essential for quality control and assurance. It aims to define specifications, processes, and provide an audit trail to investigate any defective batches. The objectives, characteristics, types, and importance of documentation are described for regulatory compliance and product quality.
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.
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 (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.
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.
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.
This document discusses pharmaceutical documentation. It defines documentation and its aims which include defining specifications, procedures, and ensuring authorized persons have necessary information. There are different types of documentation like policy documents, specifications, procedures, work instructions, and records. The document also outlines the documentation process including preparation, review, approval, distribution and revision. It describes how mistakes are corrected in documentation and concludes that documentation provides a basis for planning future manufacturing functions in a GMP environment.
This document discusses documentation in the pharmaceutical industry. It defines documentation as the process of systematically recording information about people, events, and documents to create organizational records. Good documentation is essential for quality control and assurance. It aims to define specifications, processes, and provide an audit trail to investigate any defective batches. The objectives, characteristics, types, and importance of documentation are described for regulatory compliance and product quality.
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.
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 (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.
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.
Good Document Control Practices and Procedures: ISO 9001:2015Qualsys Ltd
Read More: quality.eqms.co.uk/eqms-governance-risk-compliance-software-datasheets
Once upon a time, records lived in lever arch-files, filing cabinets and in cardboard boxes. All key documents and records were strictly guarded under lock-and-key by those who knew the rules, and applied them assiduously.
Nowadays, records exist all over the business, well beyond the reach of the traditional warden. With everything digital, records are stored on desktops or mobile devices, on clouds or on servers, on intranets or on social media.
But what impact has this decentralisation of records had on organisations?
In this fast paced, mobile world, documentation is created at break-neck pace.
Not only has the internet, remote working and globalisation completely changed the way documents are created, it has transformed how records are exchanged, viewed, interrogated and collaborated upon.
Despite the issues with lost company records, only a third of organisations feel their document control procedures are integrated enterprise-wide, according to an AIIM Industry Report.
Two in three organisations feel they have failed to integrate document control procedures across the organisation, or have little or no document control policy at all.
Not only do these companies risk litigation costs, loosing customer confidence, bad publicity and loosing confidential customer information, they are failing to exploit important knowledge resources.
EQMS Document Manager helps you to keep control of records. EQMS enables you to:
control access and usage of documented information, as well as the distribution and retrieval of documents.
Follow a systematic approach: e.g. follow the Plan > Do > Check > Act cycle.
Retain records: have documents to prove that you have done what you said you would do.
This supports organisations to meet the requirements of ISO 9001:2015 and other management standards.
CCK Discussion Forum held at ICCBS, University of Karachi, attended by over hundred of registered experienced pharmaceutical professionals participants belonging from dozen of pharmaceutical manufacturing facilities
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.
The document discusses the importance of documentation in ensuring quality. It states that documentation, in the form of documents that establish standards and processes, is a key tool for quality assurance. It also emphasizes that quality cannot be assured in a regulated industry without good documentation practices and a systematic document system. The document outlines some basic requirements and characteristics for an effective documentation system, including establishing quality standards, monitoring compliance, and managing any changes to documents or processes.
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.
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.
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.
Documentation and maintenance of records ppt by zuhaibmohd zuhaib dar
This document discusses documentation, record keeping, and the difference between documents and records. It notes that documentation provides instructions for how activities should be executed and can be in paper or electronic form. Record keeping involves organizing and storing documents related to a company's activities and records provide evidence that activities have been performed. While a document can be a procedure or specification, a record is a documented form that provides evidence of compliance with requirements. The document emphasizes the importance of documentation and record keeping.
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.
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.
A records retention schedule specifies minimum retention periods for records and authorizes their disposal. It serves as an instruction sheet for caring for and preserving records based on their administrative, legal and historical value. The scheduling process involves analyzing records, determining their value, and establishing retention periods and final dispositions. Records are classified as active, inactive or dead based on their use and retention periods. Inactive records are stored offsite until their value expires and final disposition through destruction or transfer.
Presentation for good documentary practices revised shravanshravan dubey
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.
This document provides guidance on establishing an effective document control system. It outlines key steps such as defining good documentation, determining the appropriate amount of documentation, and planning the infrastructure. Common problems are also discussed, such as inconsistent terminology, revisions not being tracked properly, and too many documents being distributed without proper control. The overall goal of document control is to maintain consistency across processes and ensure all employees perform tasks the same way.
Good Documentation Practices -Do's and Don'ts- (GCP)Piyush Wagh
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.
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.
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.
This document provides guidance on establishing an effective document control system. It outlines four key steps: 1) Ensuring documentation is clear, concise and user-friendly, 2) Having the right amount of documentation, 3) Outlining the document control system and 4) Determining the appropriate infrastructure for the company. Effective document control is important for maintaining consistent processes, yet companies often struggle with terminology, revisions, distribution and approval. Planning ahead can help avoid common problems.
Businesses create documents everyday, but without an effective filing plan, content quickly turns to chaos. Document management is the process of applying policies and rules to how documents are created, stored, updated and eventually retired. This slideshare identifies the top document management functions and how document management software can help.
For more information on document management in the cloud, visit www.fileplan.com
This document discusses various quality control and documentation procedures in the pharmaceutical industry. It includes 3 key points:
1. It discusses the importance of documentation in defining specifications, methods, providing an audit trail and ensuring authorized personnel have necessary information. This includes documents like specifications, batch production records, SOPs etc.
2. It describes procedures for developing key documents like master formulas, batch manufacturing records, audit plans and reports. This ensures uniform processes and allows tracing of batch history.
3. It discusses quality audits which systematically examine if quality activities comply with arrangements and objectives. This includes internal audits as well as those imposed by regulators or customers.
Good Document Control Practices and Procedures: ISO 9001:2015Qualsys Ltd
Read More: quality.eqms.co.uk/eqms-governance-risk-compliance-software-datasheets
Once upon a time, records lived in lever arch-files, filing cabinets and in cardboard boxes. All key documents and records were strictly guarded under lock-and-key by those who knew the rules, and applied them assiduously.
Nowadays, records exist all over the business, well beyond the reach of the traditional warden. With everything digital, records are stored on desktops or mobile devices, on clouds or on servers, on intranets or on social media.
But what impact has this decentralisation of records had on organisations?
In this fast paced, mobile world, documentation is created at break-neck pace.
Not only has the internet, remote working and globalisation completely changed the way documents are created, it has transformed how records are exchanged, viewed, interrogated and collaborated upon.
Despite the issues with lost company records, only a third of organisations feel their document control procedures are integrated enterprise-wide, according to an AIIM Industry Report.
Two in three organisations feel they have failed to integrate document control procedures across the organisation, or have little or no document control policy at all.
Not only do these companies risk litigation costs, loosing customer confidence, bad publicity and loosing confidential customer information, they are failing to exploit important knowledge resources.
EQMS Document Manager helps you to keep control of records. EQMS enables you to:
control access and usage of documented information, as well as the distribution and retrieval of documents.
Follow a systematic approach: e.g. follow the Plan > Do > Check > Act cycle.
Retain records: have documents to prove that you have done what you said you would do.
This supports organisations to meet the requirements of ISO 9001:2015 and other management standards.
CCK Discussion Forum held at ICCBS, University of Karachi, attended by over hundred of registered experienced pharmaceutical professionals participants belonging from dozen of pharmaceutical manufacturing facilities
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.
The document discusses the importance of documentation in ensuring quality. It states that documentation, in the form of documents that establish standards and processes, is a key tool for quality assurance. It also emphasizes that quality cannot be assured in a regulated industry without good documentation practices and a systematic document system. The document outlines some basic requirements and characteristics for an effective documentation system, including establishing quality standards, monitoring compliance, and managing any changes to documents or processes.
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.
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.
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.
Documentation and maintenance of records ppt by zuhaibmohd zuhaib dar
This document discusses documentation, record keeping, and the difference between documents and records. It notes that documentation provides instructions for how activities should be executed and can be in paper or electronic form. Record keeping involves organizing and storing documents related to a company's activities and records provide evidence that activities have been performed. While a document can be a procedure or specification, a record is a documented form that provides evidence of compliance with requirements. The document emphasizes the importance of documentation and record keeping.
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.
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.
A records retention schedule specifies minimum retention periods for records and authorizes their disposal. It serves as an instruction sheet for caring for and preserving records based on their administrative, legal and historical value. The scheduling process involves analyzing records, determining their value, and establishing retention periods and final dispositions. Records are classified as active, inactive or dead based on their use and retention periods. Inactive records are stored offsite until their value expires and final disposition through destruction or transfer.
Presentation for good documentary practices revised shravanshravan dubey
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.
This document provides guidance on establishing an effective document control system. It outlines key steps such as defining good documentation, determining the appropriate amount of documentation, and planning the infrastructure. Common problems are also discussed, such as inconsistent terminology, revisions not being tracked properly, and too many documents being distributed without proper control. The overall goal of document control is to maintain consistency across processes and ensure all employees perform tasks the same way.
Good Documentation Practices -Do's and Don'ts- (GCP)Piyush Wagh
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.
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.
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.
This document provides guidance on establishing an effective document control system. It outlines four key steps: 1) Ensuring documentation is clear, concise and user-friendly, 2) Having the right amount of documentation, 3) Outlining the document control system and 4) Determining the appropriate infrastructure for the company. Effective document control is important for maintaining consistent processes, yet companies often struggle with terminology, revisions, distribution and approval. Planning ahead can help avoid common problems.
Businesses create documents everyday, but without an effective filing plan, content quickly turns to chaos. Document management is the process of applying policies and rules to how documents are created, stored, updated and eventually retired. This slideshare identifies the top document management functions and how document management software can help.
For more information on document management in the cloud, visit www.fileplan.com
This document discusses various quality control and documentation procedures in the pharmaceutical industry. It includes 3 key points:
1. It discusses the importance of documentation in defining specifications, methods, providing an audit trail and ensuring authorized personnel have necessary information. This includes documents like specifications, batch production records, SOPs etc.
2. It describes procedures for developing key documents like master formulas, batch manufacturing records, audit plans and reports. This ensures uniform processes and allows tracing of batch history.
3. It discusses quality audits which systematically examine if quality activities comply with arrangements and objectives. This includes internal audits as well as those imposed by regulators or customers.
documentation in pharmaceutical industry ppt.pptxashokgorja8
To define specifications and procedures for all materials and method of manufactured and control.
To ensure that all personal concern with manufacture know what to do and when to do it.
documentation in pharmaceutical industry ppt.pptxashokgorja8
The document discusses documentation requirements in the pharmaceutical industry. It defines documentation and explains that documentation is an integral part of good manufacturing practices (GMP). It describes the objectives of documentation such as defining specifications and procedures. It provides details about types of documentation required by GMP such as master formula records, batch manufacturing records, distribution records, specifications, and quality auditing. The document emphasizes that comprehensive documentation is necessary to ensure product quality and traceability in the pharmaceutical industry.
The document provides information on the development and importance of pharmaceutical documentation. It discusses different types of documents including commitment documents like New Drug Applications and Drug Master Files, directive documents like specifications and standard operating procedures, and record documents like batch production records and protocols. The document also outlines general requirements and guidelines for designing documentation systems in accordance with cGMP.
Documentation control - principles of GMPAJAYKUMAR4872
Documentation is an essential part of QA and relates to all aspects of GMP.
The pharmaceutical industry must have a good document framework (infrastructure).
It is important for a manufacturer to get the documentation right in order to get the product right.
Unit 4 Document maintenance in Pharmaceutical Industry.pptxAshwiniBhoir2
The document discusses the importance of documentation in the pharmaceutical industry. It states that documentation provides evidence of activities and ensures quality assurance. Good documentation includes specifications, procedures, and information to ensure manufacturing processes are followed correctly. It also discusses the types of documents needed like batch production records, master formulas, standard operating procedures, distribution records, and emphasizes that documents must be properly designed, approved, distributed and updated to ensure compliance.
Document Maintenance in Pharmaceutical IndustryNAKUL DHORE
Document Maintenance in Pharmaceutical Industry.
By_ NAKUL DHORE
❖ Introduction
❖ Batch Formula Record
❖ Master Formula Record
❖ SOPs
❖ Quality Audit
❖ Quality Review & Quality Documentation
❖ Reports & Documents
❖ Distribution Records
❖ MCQs
Quality Assurance
As per B.PHARM 3rd Year Semester-6
(PCI Syllabus New)
Documentation is an essential part of good manufacturing practices in the pharmaceutical industry. Key aspects of documentation include master production records, batch records, material identification systems, laboratory records, distribution records, and complaint files. Documentation provides a complete history of each batch and helps ensure quality, traceability, and compliance with specifications and procedures. It also enables investigation of any issues that may arise.
documentation in pharmaceutical industry.pdfSoumiliPaul1
Documentation in the pharmaceutical industry plays a crucial role in maintaining quality, compliance, and safety standards. It encompasses standard operating procedures, quality audits, review of quality documentation, and generation of various reports and distribution records. Master formula records provide complete descriptions of all aspects of manufacturing, packing, and quality control. Quality audits verify that quality activities comply with plans and that arrangements are suitable to achieve objectives. Documentation includes internal audits by a company's employees and external audits by separate organizations.
"A good document process involves several key steps to ensure the creation, management, and utilization of documents in an effective and efficient manner.
In the food industry, quality accessories play a crucial role in ensuring the safety, efficiency, and effectiveness of various processes.
Read the complete article on the topics above along with new weekly buzz, highlights and fun facts in this weeks tech-knowledge."
CGMP (Current Good Manufacturing Practices) ensures that medicinal products are consistently produced and controlled to quality standards required for their intended use. QA plays an important role in CGMP by verifying equipment qualifications, approving manufacturing documents, and verifying processes like cleaning validation, data integrity, sampling, and analytical reports. Maintaining CGMP requires following written procedures, accurately recording work, validating processes, developing facilities and equipment properly, maintaining quality control through practices like hygiene, and designing quality into manufacturing processes and product life cycles.
The document discusses specifications and submission of documents for pharmaceutical products. It provides definitions and types of specifications for active materials, packing materials, intermediates, bulk, and finished products. It also discusses test procedures, protocols, reports, distribution records, electronic data handling, concepts of controlled vs uncontrolled documents, and submissions to regulators like DMFs, CTD, and eCTD. Specifications include parameters and acceptance limits. Test procedures must be validated and may reference official substances. Protocols, reports, and distribution records are important documentation for manufacturing and quality control. Electronic data handling can streamline documentation but has challenges around costs, connectivity, security, and validation.
The document provides guidelines for quality assurance documentation in the pharmaceutical industry. It outlines that documentation is essential to define specifications and procedures, ensure personnel know their responsibilities, and provide an audit trail. The summary is as follows:
1) Documentation should exist for all quality assurance aspects and be designed, prepared, reviewed and distributed carefully.
2) Documents must be unambiguous and include titles, contents, and be easy to check. Reproduced documents must be clear and legible.
3) Documentation such as specifications, batch records, testing procedures and analysis records should include details like product names, batch numbers, test methods and results to ensure traceability.
This document provides an overview of validation theory and application. It discusses the history and definition of validation, the purpose and benefits of validation, what should be validated, types of validation including retrospective and prospective validation, when revalidation is needed, organizing validation teams and planning validation with a validation master plan and matrix. It also covers specific validation activities like design qualification, installation qualification, operational qualification and performance qualification.
Validation ( process validation, TT from R&D to pilot plant)RushikeshPalkar1
The document discusses process validation in the pharmaceutical industry. It begins by defining process validation as establishing evidence through documentation that a process is capable of consistently producing a product meeting predetermined specifications and quality attributes. It then describes the three stages of process validation: process design, process qualification, and continued process verification. The document provides details about each stage and emphasizes that process validation is important for assuring pharmaceutical product quality since end product testing alone is not sufficient. It concludes by stating that if each step of production is validated, the final product quality can be assured.
Final Io Pp Mdptc Pack Expo Nov 3 2010 3KKGPackaging
This document summarizes a presentation on medical device packaging design from a regulatory compliance perspective. It discusses the key requirements for medical device packaging from standards like ISO 11607 as well as FDA regulations. It also outlines a 12 step approach for achieving the "compliance sweet spot" that balances patient safety, regulatory requirements, and business costs. The presentation provides examples of performance testing and estimates that the total time to design, validate, and approve a new medical device packaging system is typically around 52 weeks.
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
Patient compliance with medical adviceRavish Yadav
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
This document defines osmosis and osmotic pressure, and describes how osmotic systems utilize these principles for controlled drug delivery. It discusses the basic components of osmotic systems, including drugs, osmotic agents, semi-permeable membranes, and plasticizers. It also describes various types of osmotic systems for both oral and implantable drug delivery, including elementary osmotic pumps, push-pull osmotic pumps, and implantable mini-osmotic pumps. The document provides equations to describe drug release from these systems driven by osmotic pressure.
The document discusses opioid analgesics and their mechanisms of action. It notes that the body has an endogenous analgesic system centered in the brainstem that is stimulated by opioids. Opioids work by binding to mu, delta, and kappa receptors in the brain and spinal cord, inhibiting pain signal transmission. Several opioid analgesics are described, including morphine, codeine, heroin, fentanyl, and methadone. Tolerance, side effects, metabolism, and antagonists are also discussed. The future of opioid analgesics is seen to involve further study of the kappa receptor and endogenous opioid peptides to develop safer drugs.
Infrared spectrum / infrared frequency and hydrocarbonsRavish Yadav
This document provides information about infrared (IR) spectroscopy and analyzing IR spectra of different functional groups. It discusses:
1. The conditions required for IR absorption and the division of the IR spectrum into the functional group and fingerprint regions.
2. The characteristic IR absorptions of common functional groups like alkanes, alkenes, alkynes, alcohols, phenols, ethers, aldehydes, ketones, carboxylic acids, esters, amides, amines, and aromatics. Specific examples and their spectra are provided.
3. Factors that affect IR frequencies, such as bond strength, mass of atoms, resonance, conjugation, and hydrogen bonding.
Neurotransmitters are endogenous chemicals that transmit signals between neurons. The major categories are small-molecule neurotransmitters like acetylcholine and amino acids, and large peptides. They act on ligand-gated ion channels or G protein-coupled receptors. After release, they are typically removed from the synapse by reuptake back into the presynaptic neuron or breakdown by enzymes. Examples include acetylcholine, which activates nicotinic and muscarinic receptors, and glutamate, the main excitatory neurotransmitter in the brain. GABA is the primary inhibitory neurotransmitter and binds GABAA/B/C receptors. Neuropeptides are longer amino acid chains that modulate synaptic transmission.
Narcotic drugs and psychotropic substances act, 1985Ravish Yadav
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
Medicinal and toilet preparations (excise duties) act, 1995 and rules, 1956Ravish Yadav
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Lipids can be classified by their structure as simple lipids like fats and oils or complex lipids like phospholipids. They can also be classified based on whether they undergo hydrolysis in alkaline solutions. Lipids are made up of fatty acids and glycerol, forming triglycerides. Fats are usually saturated while oils contain some unsaturated fatty acids. Waxes differ from fats and oils in that they are esters of long-chain alcohols and fatty acids with higher melting points. Lipids serve important functions and have many applications, such as in soaps, foods, and cosmetics.
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The all the content in this profile is completed by the teachers, students as well as other health care peoples.
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The document summarizes the tricarboxylic acid (TCA) cycle, also known as the Krebs cycle or citric acid cycle. It discusses that the TCA cycle involves the oxidation of acetyl-CoA to carbon dioxide and water and is the final common pathway for carbohydrates, fats, and amino acids. The cycle occurs in the mitochondrial matrix and generates energy in the form of NADH and FADH2 that are used in the electron transport chain to produce ATP. Key enzymes and reactions in the cycle are described, including the generation of citrate, isocitrate, alpha-ketoglutarate, succinyl-CoA, fumarate, oxaloacetate
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Anti mycobacterial drugs (tuberculosis drugs)Ravish Yadav
This document discusses anti-mycobacterial drugs used to treat tuberculosis. It begins by describing tuberculosis and how it is caused by the bacterium Mycobacterium tuberculosis. First-line drugs to treat tuberculosis are listed as isoniazid, rifampin, pyrazinamide, ethambutol, and streptomycin. Each drug's mechanism of action and potential resistance issues are then explained individually. Second-line drugs discussed include ethionamide, capreomycin, cycloserine, aminosalicylic acid, and fluoroquinolones. Common adverse drug reactions are also outlined.
This document provides information on various anti-malarial agents. It discusses the life cycle of Plasmodium parasites and the four species that cause malaria in humans. It then describes various classes of anti-malarial drugs including those derived from natural sources like cinchona alkaloids and artemisinin, as well as synthetic agents like chloroquine, primaquine, mefloquine, and antifolate drugs. For each class, it provides details on examples, mechanisms of action, structure-activity relationships, resistance issues, and pharmacological properties. The document aims to comprehensively cover the major therapeutic options available to treat malaria.
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The all the content in this profile is completed by the teachers, students as well as other health care peoples.
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Main Java[All of the Base Concepts}.docxadhitya5119
This is part 1 of my Java Learning Journey. This Contains Custom methods, classes, constructors, packages, multithreading , try- catch block, finally block and more.
A workshop hosted by the South African Journal of Science aimed at postgraduate students and early career researchers with little or no experience in writing and publishing journal articles.
Chapter wise All Notes of First year Basic Civil Engineering.pptxDenish Jangid
Chapter wise All Notes of First year Basic Civil Engineering
Syllabus
Chapter-1
Introduction to objective, scope and outcome the subject
Chapter 2
Introduction: Scope and Specialization of Civil Engineering, Role of civil Engineer in Society, Impact of infrastructural development on economy of country.
Chapter 3
Surveying: Object Principles & Types of Surveying; Site Plans, Plans & Maps; Scales & Unit of different Measurements.
Linear Measurements: Instruments used. Linear Measurement by Tape, Ranging out Survey Lines and overcoming Obstructions; Measurements on sloping ground; Tape corrections, conventional symbols. Angular Measurements: Instruments used; Introduction to Compass Surveying, Bearings and Longitude & Latitude of a Line, Introduction to total station.
Levelling: Instrument used Object of levelling, Methods of levelling in brief, and Contour maps.
Chapter 4
Buildings: Selection of site for Buildings, Layout of Building Plan, Types of buildings, Plinth area, carpet area, floor space index, Introduction to building byelaws, concept of sun light & ventilation. Components of Buildings & their functions, Basic concept of R.C.C., Introduction to types of foundation
Chapter 5
Transportation: Introduction to Transportation Engineering; Traffic and Road Safety: Types and Characteristics of Various Modes of Transportation; Various Road Traffic Signs, Causes of Accidents and Road Safety Measures.
Chapter 6
Environmental Engineering: Environmental Pollution, Environmental Acts and Regulations, Functional Concepts of Ecology, Basics of Species, Biodiversity, Ecosystem, Hydrological Cycle; Chemical Cycles: Carbon, Nitrogen & Phosphorus; Energy Flow in Ecosystems.
Water Pollution: Water Quality standards, Introduction to Treatment & Disposal of Waste Water. Reuse and Saving of Water, Rain Water Harvesting. Solid Waste Management: Classification of Solid Waste, Collection, Transportation and Disposal of Solid. Recycling of Solid Waste: Energy Recovery, Sanitary Landfill, On-Site Sanitation. Air & Noise Pollution: Primary and Secondary air pollutants, Harmful effects of Air Pollution, Control of Air Pollution. . Noise Pollution Harmful Effects of noise pollution, control of noise pollution, Global warming & Climate Change, Ozone depletion, Greenhouse effect
Text Books:
1. Palancharmy, Basic Civil Engineering, McGraw Hill publishers.
2. Satheesh Gopi, Basic Civil Engineering, Pearson Publishers.
3. Ketki Rangwala Dalal, Essentials of Civil Engineering, Charotar Publishing House.
4. BCP, Surveying volume 1
Walmart Business+ and Spark Good for Nonprofits.pdfTechSoup
"Learn about all the ways Walmart supports nonprofit organizations.
You will hear from Liz Willett, the Head of Nonprofits, and hear about what Walmart is doing to help nonprofits, including Walmart Business and Spark Good. Walmart Business+ is a new offer for nonprofits that offers discounts and also streamlines nonprofits order and expense tracking, saving time and money.
The webinar may also give some examples on how nonprofits can best leverage Walmart Business+.
The event will cover the following::
Walmart Business + (https://business.walmart.com/plus) is a new shopping experience for nonprofits, schools, and local business customers that connects an exclusive online shopping experience to stores. Benefits include free delivery and shipping, a 'Spend Analytics” feature, special discounts, deals and tax-exempt shopping.
Special TechSoup offer for a free 180 days membership, and up to $150 in discounts on eligible orders.
Spark Good (walmart.com/sparkgood) is a charitable platform that enables nonprofits to receive donations directly from customers and associates.
Answers about how you can do more with Walmart!"
This presentation includes basic of PCOS their pathology and treatment and also Ayurveda correlation of PCOS and Ayurvedic line of treatment mentioned in classics.
This presentation was provided by Steph Pollock of The American Psychological Association’s Journals Program, and Damita Snow, of The American Society of Civil Engineers (ASCE), for the initial session of NISO's 2024 Training Series "DEIA in the Scholarly Landscape." Session One: 'Setting Expectations: a DEIA Primer,' was held June 6, 2024.
Leveraging Generative AI to Drive Nonprofit InnovationTechSoup
In this webinar, participants learned how to utilize Generative AI to streamline operations and elevate member engagement. Amazon Web Service experts provided a customer specific use cases and dived into low/no-code tools that are quick and easy to deploy through Amazon Web Service (AWS.)
Beyond Degrees - Empowering the Workforce in the Context of Skills-First.pptxEduSkills OECD
Iván Bornacelly, Policy Analyst at the OECD Centre for Skills, OECD, presents at the webinar 'Tackling job market gaps with a skills-first approach' on 12 June 2024
How to Setup Warehouse & Location in Odoo 17 InventoryCeline George
In this slide, we'll explore how to set up warehouses and locations in Odoo 17 Inventory. This will help us manage our stock effectively, track inventory levels, and streamline warehouse operations.
A review of the growth of the Israel Genealogy Research Association Database Collection for the last 12 months. Our collection is now passed the 3 million mark and still growing. See which archives have contributed the most. See the different types of records we have, and which years have had records added. You can also see what we have for the future.
2. Introduction
• It is a piece of paper/ memorandum containing information or matter,
evidence of a process or instructions to carry out a procedure.
• It is an integral part of:
• GMP (GDP)
• QA system
• ISO 9000 requirement
2
4. Need
1) It is a comprehensive system so designed, written, implemented and
controlled so as to provide information on each and every aspect of QC
or QA.
2) It is about establishing written instructions for significant activities,
following those instructions in practice and making records of those
activities.
4
5. 3) It defines system of information and control so that risks so inherent
in misinterpretation and/ or error in oral communication are minimized.
4) It strengthens quality and its consistency in all goods and services as
those responsible for specific operation have clear unambiguous
instructions to follow.
5
6. Importance of documentation in quality assurance
1. Scientific purpose
Written protocol- identifies material to be used, conditions to
be used and data to be obtained.
Conclusion drawn from the analysis of data whether or not a
product has a therapeutic merit. If favorable conclusion then,
product is suitable for marketing.
7. 2. Regulatory Purposes
• Maintaining of some records-legal requirement by US FDA cGMP or
Schedule U
• Documents generated during manufacturing of drug constitutes legal
evidence which may be used to decide how well a firm fulfills its legal
obligations.
• Important for parenteral drug manufacture as FDA investigators
routinely check validation data for sterilization process.
• Information contained in records must be able to answer questions of
regulatory officials regarding identity, quality, purity, safety and
effectiveness of product.
8. 3. Business Purpose
• Records generated in conjunction with the production of a drug
• Neither required by the law nor needed to demonstrate the quality of
product
• Supplementary to the processing of the batch
• Prepared from raw data generated during manufacture of individual
batches
• Intention- improving efficiency and obtaining cost saving
• Information – useful for providing reports of production status and for
determining labor standards, overhead costs and degree of success in
meeting standards of quality
9. Requirements of a document
Evidence of proof of activities
Helps in traceability
Helps in correction and prevention of faults
Helps in creating awareness
Required for audits
Legal requirement (GMP)
9
10. Features of documents
1) Documents should be designed, prepared, reviewed and distributed
with care.
2) They should comply with relevant parts of manufacturing and
marketing authorization.
3) Documents should be approved, signed and dated by appropriate
authorised persons.
4) It should have an identification number.
5) No documents should be changed without authorisation.
10
11. 6) Documents should have unambiguous contents.
7) Title, nature and purpose should be clearly stated.
8) They should be laid out in orderly fashion and should be easy to
check.
9) Reproduced document should be clear and legible.
10) The reproduction of working documents from master documents
must not allow any error to be introduced through the reproduction
process.
11
12. 11) Documents should be reviewed regularly and should be kept up to
date.
12) When a document is revised, a system should exist to prevent
intentional use of superseded version.
13) Such reviewed documents should be approved, signed and dated by
authorised persons.
12
13. 14) Whenever document requires entry of data, those entries should be
clear, legible and indelible. Sufficient space should be provided for
such entries. Such entries should be signed and dated by person
making the entry.
15) Any alteration made to a document should be singed and dated. The
alteration should permit the reading of original information.
Wherever appropriate, reason for alteration should be recorded.
16) Each document should have date of issue and due date of revision
13
14. 17) Records should be made or completed when any action is taken and
in such a way that all significant activities concerning the manufacture
of pharmaceutical products are traceable.
18) Records and associated SOPs should be retained for at least one year
after expiry date of finished product.
19) Data must be recorded by electronic data processing systems or by
photographic or other reliable means.
20) Master formulae and detailed SOP should be available and accuracy
of records should be checked.
14
15. 21) Only authorized person should modify the data in computer and a
record of changes and deletions should be maintained. Access should
be restricted by passwords or other means.
22) Batch records electronically stored should be protected by back-up
transfer.
23) During the period of retention, the data are readily available.
24) Old documents should be discarded.
25) All departments should be informed of given revised additions.
15
16. 26) Any change in data which will cause change in end product quality
must be cancelled.
27) A list of all receiving departments should be made whenever each
document is received by different departments.
28) The receiving department should check the following aspects:
Whether they have been given a new document
Whether they are using new documents
Whether they have discarded the old document.
16
18. 1) Records – must reflex accuracy, totality, simplicity, efficiency,
reliability, low cost, efficacy. They also include reports.
2) Procedural manual – e.g. Departmental manuals, SOP
3) Functional document or apex manual – Quality policy manual, labels
of finished products, intermediates etc.
18
20. Criteria for documentation
1. Nature of document should be clearly understood.
2. Easily adoptable
3. Precise
4. Sufficient space available for all entries
5. Written in ink
6. No overwriting allowed
7. Should be update
8. Periodically reviewed for modification
9. All documents should be designed in concurrence with
QA department
10. Should be approved by QA Head
22. Approval
22
This applies particularly to work instructions, procedures,
manufacturing formulae and specifications.
Approval should be by the relevant technical, management and
quality personnel, to ensure that documents comply with the
principles of GMP and the specific product marketing and
manufacturing authorisations
23. Clarity
23
They should not be open to misinterpretation by the users.
They should be written in a way that makes them easy to check,
particularly when they will form part of a product manufacturing
history.
Good documentation design will help to minimize errors
24. Regular review and update
24
Documents must be kept up-to-date with changes in regulations
or processes and should be distributed in a controlled manner
to ensure that only the most recent versions are available for
use.
They must also be available to those who need them, where
they need them!
25. Formal presentation
25
Controlled documents should be prepared in accordance with a
written procedure, now a days probably using a computerised
documentation control system.
26. Records
26
Should be made at the time of each action - do not rely on
memory for their completion.
Records relating to manufacturing or testing operations should
be kept for at least one year after their expiry.
If documents or data are stored electronically, the computer
system must be validated to assure data security and integrity.
Provisions must also be made to retrieve the stored data,
possibly years after they have been generated
27. Strengths of Good Documentation
27
- Clear Objective of the document
- Clarity of Scope
- Who should prepare?
- Layout of the document in mind
- Explain the activity performed
logically
- Use short, simple, easy to
understand sentences
- Maintain flow of script
- Match script to the sequence of
events of the activity
- Use correct data format
- Meaningful data will give
meaningful information
- Draw neat and correct inference
- Conclusion & Summary
29. Pre-production records
1. Material receipt records
2. RM analytical record
3. Material stock and utilization
4. Material requisition record
5. Others
30. Material receipt record
• Name of the item
• Date of receipt
• Name of manufacturer
• Name of supplier
• Quantity received
• No. of containers
• Manufacturing lot no.
• Expiry/ re-test date
31. RM analytical record
• Material receiving no.
• Manufacturers description
• Standard name
• Date of receipt
• Total quantity received
• Name of manufacturer
• Name of supplier
• Manufacturing lot no.
• Sampling date
• Sampled by
• No. of containers and quantity sampled
• Tests or assay carried out
• Approval or rejection
• Expert staff sign (approval)
32. Material stock record
• Store keeper receives the material, opens packs and find the
damage and records following.
• Date of receipt
• Name of material
• Supplier’s name
• Supplier’s Batch no.
• Quantity of and containers
• Batch no of receiving company
• Exp. Date if any
• The records are sent to QA to sample raw material. Samples are
sampled according to sampling plan.
33. Material utilization record
•Standard name of material
•Code no.
•Receiving report no.
•Quantity issued for manufacturing purpose
•Sign of staff responsible for receipt and issue of
materials
34. Material requisition record
• Standard name of material
• Code no.
• Quantity required for batch
• Material receiving no.
• Batch/ lot no.
• Signature of weigher and checker for quantities
• Sign of senior receiver in production department
35. Packing material
a. SAMPLING
1. Sampling plan
2. Method of sampling
3. Instructions for sampling
b. STORES RECORDS
1. Name of material
2. Quantity received
3. Supplier’s name
c. ANALYSIS RECORDS
1. Approved specification/ blue prints should be available
2. Procedures of testing to be followed
37. Intermediate and bulk products
1. Stages at which to take sample.
2. Method of sampling.
3. Approved specifications & method of analysis.
4. Information of processing department.
38. Filling or packaging record
• Name of product
• Batch/ lot no.
• Batch/ lot size
• Control release no.
• No. of total containers filled in various sizes
• Date of commencement and completing of filling
• Observations in connection with all in-process controls
• Theoretical quantities of printed material required
• Actual quantities of printed material received with sign
• Date of commencement and completing of packing
• Quantity of defective packings and their disposal
• Sign of responsible staff and supervisors
• Balance of unused packing material and its disposal
40. Post-production records
1. Packing records
2. Records of shelf life studies
3. Complaint records
4. Distribution records
5. Product recall records
6. Others
41. Packing records
a. List of approved packaging components with
standard cards of each item
b. Batch ticket
1. Name of product
2. Batch No
3. Strength
4. Pack size
5. Number
42. 6. Pack weight
7. Volume
8. Quantity received from packing
9. Mfg. date and Exp. Date
10. Yield against standard yield
11. Rejection percentage
12. Details of in process control and observations
13. Date of commencement and completion of packing
43. Shelf life records (stability studies records)
• Address of manufacturer
• Summary of stability testing
• Name of product
• Packing material
• Details of batch included in the study i.e. batch no., batch size, type of batch
(experimental/ production)
• Storage condition i.e. temperature, humidity, light
• Results of testing
Test Result after months
0 1 2 3 6 12 other
• Conclusion
• Name of analyst
• Sign of analyst
• Sign of QC head with date
44. Distribution records
To facilitate effective records, the records should
include all details such as
1. Name of person to whom supplied.
2. Batch no.
3. Quantity
4. Destination
5. Challan no.
45. Complaint records
• Name of product
• Batch/ lot no.
• Date of manufacture and expiry
• Date of receiving complaint
• Details of complaint i.e. place of origin, name of the person filing
the complaint
• Nature of complaint
• Observation with regards to condition and examination of
control or reference sample
• Analysis of complaint
• Action taken for withdrawal of complaint batch
• Action required to be taken to prevent recurrence of complaint
46. Miscellaneous records
• Instrument calibration records
• Validation records
–Installation qualification
–Operational qualification
–Computer validation
–Process validation
–Supplier validation
–Analytical validation
• Vendor approval records
47. • Environmental monitoring records
• Equipment cleaning and maintenance records
• Sanitation records
• Pest control measures
• Training of personnel
• Reprocessing records
• Returned goods documentation
• Salvaging documents
49. Reports
•Secondary documents
•Prepared from information contained in one or
more records
•Help in drawing conclusion from records
•Two types
• Internally generated reports
• Externally generated reports
50. Internally generated record
• Investigations of deviation
–Description of discrepancy or failure
–Efforts taken to locate the cause
–Results of efforts
–Conclusion drawn
–Action taken
• Reports of analysis – to be sent to government agencies
• Trend analysis – the quality standard of each drug
annually
51. • Internal audits
• Recalls
–No. of consignees notified and method of notification
–No. of consignees responding
–No. of consignees not responding
–Quantity of recalled material on hand
–no. of effectiveness checks performed and their
results
–Estimated time frame for completion
–Report of disposition of material
53. Master documentation file
• Provides complete history of product
1. Active component characteristics
– Material specification
– Analytical method
– Stability reports
2. Product specifications
– Equipment specification
– FP specification
– Stability reports
3. Process specifications
– Qualification protocols
– Plant qualification reports
– Process data
4. MFR
54. Retention of records
•Reports pertaining to production/ manufacturing –
depends on shelf life of product
•Records pertaining to components, containers,
closures, labeling etc – 1 year after expiry of batch in
which they were used
55. Maintenance of documents
The Management Representative (MR) for the system is responsible
for maintaining documents.
His duties:
He will have records and lists of distribution of all the
documents
Any change in data which is going to affect the end
product quality must be cancelled.
55
57. Retrieval of documents
• cGMP requires that the production and control
records be available for review and inspection
• Thus, a well defined system needed
• Two types of system
1. Manual system
2. Automated system
58. Manual system
•Individual file jacket for each product
•Jackets identified with batch no.
•Filed consecutively by batch no. in a central facility
•Contains originals (copies permitted)
•Requires considerable amount of space
59. Automated systems
• Computerisation associated with lab, storage, manufacturing
etc
• Should be routinely inspected and validated
• Changes by authorised personnel only
• Backup file mandatory
• Hard copy to be maintained