This document describes a case study on implementing change control for a Brookfield viscometer that was experiencing frequent spindle speed changes without human handling. This was affecting manufacturing processes and resulting in misleading viscosity readings. A change control process was initiated to address calibration intervals and validation procedures for the viscometer. Documentation was created justifying the need for the change and submitted to the quality assurance team for review and approval. Once approved, the change was implemented.
The document discusses batch production record (BPR) review and release. It defines key terms like deviations, critical process parameters, critical quality attributes. It outlines regulatory requirements from ICH Q7, CFR 211, and consequences of non-compliance. The objectives of BPR review are to confirm the batch quality and was produced under control. Records of critical steps must be reviewed and approved by quality before release. Failure to comply with cGMPs can render a drug adulterated under the FDA act.
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
The document provides information on documentation practices in the pharmaceutical industry. It discusses why documentation is important, defining documentation as written evidence of activities. It states that regulatory bodies prioritize reviewing documents to verify activities. Good documentation practices, including systematic preparation and review of documents, are required to prevent errors and ensure compliance. Documentation provides records, traceability, and audit trails for investigation and review.
This document discusses change control in the pharmaceutical industry. It defines change and change control, and outlines the tasks, principles, regulatory requirements, and elements of a change control system. The document describes the steps in a typical change control process, including classifying, assessing, planning, implementing, evaluating, and closing changes. It provides examples of major and minor changes and discusses the documentation and challenges of maintaining an effective change control system. Maintaining proper communication, turnaround times, documentation, and training are important for managing changes in a controlled manner.
OOS and OOT investigation is always a challenging task. This slide may help for a better understanding of investigation procedure according to regulatory requrement.
This document describes a case study on implementing change control for a Brookfield viscometer that was experiencing frequent spindle speed changes without human handling. This was affecting manufacturing processes and resulting in misleading viscosity readings. A change control process was initiated to address calibration intervals and validation procedures for the viscometer. Documentation was created justifying the need for the change and submitted to the quality assurance team for review and approval. Once approved, the change was implemented.
The document discusses batch production record (BPR) review and release. It defines key terms like deviations, critical process parameters, critical quality attributes. It outlines regulatory requirements from ICH Q7, CFR 211, and consequences of non-compliance. The objectives of BPR review are to confirm the batch quality and was produced under control. Records of critical steps must be reviewed and approved by quality before release. Failure to comply with cGMPs can render a drug adulterated under the FDA act.
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
The document provides information on documentation practices in the pharmaceutical industry. It discusses why documentation is important, defining documentation as written evidence of activities. It states that regulatory bodies prioritize reviewing documents to verify activities. Good documentation practices, including systematic preparation and review of documents, are required to prevent errors and ensure compliance. Documentation provides records, traceability, and audit trails for investigation and review.
This document discusses change control in the pharmaceutical industry. It defines change and change control, and outlines the tasks, principles, regulatory requirements, and elements of a change control system. The document describes the steps in a typical change control process, including classifying, assessing, planning, implementing, evaluating, and closing changes. It provides examples of major and minor changes and discusses the documentation and challenges of maintaining an effective change control system. Maintaining proper communication, turnaround times, documentation, and training are important for managing changes in a controlled manner.
OOS and OOT investigation is always a challenging task. This slide may help for a better understanding of investigation procedure according to regulatory requrement.
The document compares US Drug Master Files (DMFs) and European Union Drug Master Files (EDMFs), which include Certificates of Suitability (CEPs) and Active Substance Master Files (ASMFs). Some key differences include:
- EDMFs allow protection of intellectual property while providing complete information to regulators, whereas DMF submission is optional in the US.
- CEP and ASMF review processes in the EU can include multiple rounds of evaluation and inspections, whereas the FDA only reviews a DMF when referenced in an application.
- EDMF submissions must follow eCTD format and include modules on quality, nonclinical and clinical information, while DMFs can still
The document outlines procedures for investigating out-of-specification or atypical laboratory test results. It describes conducting a Phase I investigation by the analyst and supervisor to identify obvious errors, and a Phase II investigation when no error is found. Phase II may involve hypothesis testing, retesting using the original sample if possible, or obtaining a new sample. If no assignable cause is identified after manufacturing and laboratory investigations, retesting a portion of the original sample may be considered with approval of a documented test plan.
Regulatory aspect of pharmaceutical change control systemDeveshDRA
The document discusses the regulatory aspects of pharmaceutical change control systems. It outlines the benefits of a change control system, including ensuring changes are properly documented, validated, approved and traceable. It describes the different categories of changes (major, moderate, minor) and approval processes. A successful change control system requires identifying the need for a change, reviewing documentation, preparing a change proposal, classifying and approving the change, developing an implementation plan, verification and closure. Regulatory guidelines require formal change control systems to evaluate all changes that could affect product quality or manufacturing processes.
Site Master File or SMF is a document in the pharmaceutical industry which provides information about the production and control of manufacturing operations. The document is created by a manufacturer.
It's a document prepared by the manufacturer containing specific and factual GMP information about the production and/or control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceutical operation is carried out on the site, the site master file need describe only those operations, e.g., analysis, packaging.
The document discusses a proposed change in the coating process for Dapakan 500mg film coated tablets from a solvent coating to an aqueous coating. It describes changing from coating with Opadry OIC 7000 to coating with Opadry II. A risk assessment is proposed to evaluate any changes in color, weight gain, thickness or process validation needs. The impact on materials management, quality control, quality assurance, production and regulatory requirements is evaluated. References from regulatory bodies on quality guidelines and GMP are also provided.
Change control is a formal system to review proposed and actual changes that could affect a product's validated status. It aims to determine if actions are needed to maintain validation. Changes are classified as minor, major, or critical based on their potential safety/efficacy impact. Approval levels 1-3 require sign-off from different departments. The change control procedure involves documenting changes using a form, assessing the need and approving/rejecting changes, planning implementation, verifying the implementation, and closing the change request once complete.
This document summarizes the objectives and classification system of the Global Harmonization Task Force (GHTF) for in vitro diagnostic (IVD) medical devices. The GHTF was founded in 1993 to harmonize medical device regulations globally. It aims to facilitate trade while preserving public health. IVD medical devices are classified into 4 risk-based classes (A to D) based on 16 general rules related to device invasiveness, energy use, and disease detection. Class A devices pose the lowest risk while Class D the highest. The classification system aims to ensure regulatory oversight is proportionate to device risk.
The document defines FDA warning letters and describes the process of FDA inspections that can lead to warning letters. It explains that warning letters notify companies of violations found during inspections and investigations. Companies must promptly correct issues and FDA will check that corrections are adequate. The document also describes different types of warning letters for various regulated industries and how to browse existing warning letters on the FDA website.
Product registration and drug approval process in uskeerthi09
The document summarizes the key aspects of the new drug application (NDA) and abbreviated new drug application (ANDA) processes in the United States. It describes the requirements for NDAs, including the 20 sections that make up an NDA and the information contained within them. It also discusses ANDA requirements for generic drugs, such as bioequivalence studies and patent certifications that are part of the review process. The review processes for both NDAs and ANDAs by the FDA are also briefly outlined.
Center for Biologics Evaluation and ResearchRajeswariS12
The Center for Biologics Evaluation and Research (CBER) is one of six main centers of the US Food and Drug Administration that regulates biological products intended for human use. CBER is responsible for ensuring the safety, purity, potency, and effectiveness of biologics such as vaccines, blood products, cell and gene therapies. It oversees the testing, licensing, and post-market monitoring of these products. CBER staff review clinical trial data submitted in Biologics License Applications to determine if a biologic is safe and effective before approval.
The document discusses the ASEAN Common Technical Dossier (ACTD) format for pharmaceutical product registration applications submitted to ASEAN regulatory authorities. The ACTD format aims to standardize applications to reduce submission time and resources while facilitating regulatory review. It includes four parts covering administrative data, quality, nonclinical, and clinical information. The ACTD guideline describes the sections within each part, including overviews, summaries, study reports, and references. The standard format seeks to provide a consistent and transparent presentation of technical information to support evaluation and understanding of registration applications.
Process validation establishes documented evidence that a manufacturing process will consistently produce products meeting specifications. It involves qualifying facilities and equipment, validating critical process parameters, and revalidating when changes occur. Validation includes prospective validation of new processes and retrospective validation of existing stable processes by statistical analysis of historical batch data. Documentation of the validation master plan, protocols, reports, and results provide assurance that processes are properly controlled.
The document discusses guidelines from the International Conference on Harmonization (ICH) related to quality and specifications of pharmaceutical products. It describes several ICH Q guidelines including Q1 on stability testing, Q2 on analytical method validation, Q3 on impurities, Q4 on pharmacopoeial harmonization, and Q5 on biotechnological/biological products. Key points covered include requirements for stability testing protocols, validation of analytical methods, identification and qualification of impurities, harmonization of pharmacopoeial standards, and viral safety evaluation of cell-derived biopharmaceuticals.
Abriviated new drug application 505(j) fillingshahnawazQuadir
An abbreviated new drug application (ANDA) allows generic drug manufacturers to file for FDA approval of a generic drug. The ANDA relies on the safety and efficacy data of an approved innovator drug and must demonstrate bioequivalence through bioavailability/bioequivalence studies. There are different types of ANDA applications including Paragraph I, II, III, and IV, with Paragraph IV applications being used when a generic applicant is attempting to enter the market before patent expiration by claiming the patents are invalid or would not be infringed by the generic product. The ANDA review process involves a 30 month stay if the innovator sues for patent infringement within 45 days, during which time the first approved generic receives 180 days of market
regulatory approval process of drug, cosmetic and herbals in canada Richa Patel
The document discusses the regulatory approval process for drugs, cosmetics, nutraceuticals, and herbal products in Canada. It provides details on:
1) How drugs are reviewed and authorized for sale once they have undergone assessment by Health Canada for safety, efficacy, and quality.
2) The roles and responsibilities of the Health Products and Food Branch in regulating therapeutic and diagnostic products in Canada.
3) The definitions of key terms like drugs, cosmetics, natural health products, and personal care products according to Canadian regulations.
The document summarizes regulatory considerations for pharmaceuticals in Japan, including manufacturing, packaging, labeling, and post-marketing surveillance. For manufacturing, drugs must be approved by the Ministry of Health, Labor and Welfare and manufacturers must be licensed and follow good manufacturing practices. Packaging and labeling must contain specified information and any changes require relabeling. Post-marketing surveillance involves adverse event reporting, drug reexaminations every few years to reconfirm safety and efficacy, and reevaluations based on current medical knowledge.
The document provides guidelines for handling out of specification test results as outlined by the USFDA. It defines an out of specification result as one that falls outside the defined test limits. It discusses the USFDA's OOS guidelines published in 2006 and notes that quality units should have a defined SOP for addressing OOS results. The SOP scope should be well defined and investigations into OOS results should be thorough, timely, unbiased, well documented, and scientifically sound. Laboratory investigations should check for errors and, if none are found, a phase II investigation including retesting and investigation at the plant may be initiated. Tools like 5M, 5 whys, DMAIC and root cause analysis should be used to identify
This document provides an introduction to auditing and the audit process. It defines an audit as the on-site verification of a process or quality system to ensure compliance. Audits can be conducted internally or externally according to ICH guidelines. The objectives of an audit are to determine conformity or nonconformity with quality systems and to improve quality. Pharmaceutical manufacturers use GMP audits to verify manufacturing controls and permit timely problem correction. Management audits comprehensively examine an organization. Audits can be first, second, or third party. An auditor's responsibilities include providing audit reports and identifying issues. The planning process for an audit involves announcing a schedule, conducting meetings, performing the audit, and providing follow-up.
1. The PMDA (Pharmaceuticals and Medical Devices Agency) is the Japanese regulatory agency that reviews submissions for drug and medical device approval to ensure safety, efficacy, and quality. It was established in 2004.
2. To market a drug in Japan, approval must be obtained for each product by demonstrating efficacy and safety through examinations. Foreign manufacturers must be accredited through the FMA process. Medical devices are classified and require pre-market notification, certification, or approval depending on the risk class.
3. Registering products in Japan requires navigating a complex process that can involve clinical trials and high fees. Pursuing product registration requires carefully considering the market demand to determine if pursuing approval is worthwhile.
The document discusses out-of-specification (OOS) test results and the process for investigating them. OOS results occur when analytical results fall outside established specification ranges. There are guidelines from organizations like MHRA, CDER, and PIC/S for handling OOS products. Investigations of OOS results involve a Phase I laboratory investigation and may proceed to Phase II and III manufacturing investigations. The goal is to determine the root cause and decide if corrective actions can resolve the issue or if the batch must be rejected.
An out of specification (OOS) occurs when analytical results fall outside established specification ranges. There are guidelines from organizations like MHRA, CDER, and PIC/S for handling OOS events. OOS can occur during stability studies, finished products, or raw materials due to laboratory errors, process issues, or sample homogeneity problems. Investigations follow a phased approach starting with the quality control laboratory and then involving manufacturing operations if needed. The fate of an OOS batch may include reprocessing, reworking, or destruction depending on the investigation conclusions.
The document compares US Drug Master Files (DMFs) and European Union Drug Master Files (EDMFs), which include Certificates of Suitability (CEPs) and Active Substance Master Files (ASMFs). Some key differences include:
- EDMFs allow protection of intellectual property while providing complete information to regulators, whereas DMF submission is optional in the US.
- CEP and ASMF review processes in the EU can include multiple rounds of evaluation and inspections, whereas the FDA only reviews a DMF when referenced in an application.
- EDMF submissions must follow eCTD format and include modules on quality, nonclinical and clinical information, while DMFs can still
The document outlines procedures for investigating out-of-specification or atypical laboratory test results. It describes conducting a Phase I investigation by the analyst and supervisor to identify obvious errors, and a Phase II investigation when no error is found. Phase II may involve hypothesis testing, retesting using the original sample if possible, or obtaining a new sample. If no assignable cause is identified after manufacturing and laboratory investigations, retesting a portion of the original sample may be considered with approval of a documented test plan.
Regulatory aspect of pharmaceutical change control systemDeveshDRA
The document discusses the regulatory aspects of pharmaceutical change control systems. It outlines the benefits of a change control system, including ensuring changes are properly documented, validated, approved and traceable. It describes the different categories of changes (major, moderate, minor) and approval processes. A successful change control system requires identifying the need for a change, reviewing documentation, preparing a change proposal, classifying and approving the change, developing an implementation plan, verification and closure. Regulatory guidelines require formal change control systems to evaluate all changes that could affect product quality or manufacturing processes.
Site Master File or SMF is a document in the pharmaceutical industry which provides information about the production and control of manufacturing operations. The document is created by a manufacturer.
It's a document prepared by the manufacturer containing specific and factual GMP information about the production and/or control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceutical operation is carried out on the site, the site master file need describe only those operations, e.g., analysis, packaging.
The document discusses a proposed change in the coating process for Dapakan 500mg film coated tablets from a solvent coating to an aqueous coating. It describes changing from coating with Opadry OIC 7000 to coating with Opadry II. A risk assessment is proposed to evaluate any changes in color, weight gain, thickness or process validation needs. The impact on materials management, quality control, quality assurance, production and regulatory requirements is evaluated. References from regulatory bodies on quality guidelines and GMP are also provided.
Change control is a formal system to review proposed and actual changes that could affect a product's validated status. It aims to determine if actions are needed to maintain validation. Changes are classified as minor, major, or critical based on their potential safety/efficacy impact. Approval levels 1-3 require sign-off from different departments. The change control procedure involves documenting changes using a form, assessing the need and approving/rejecting changes, planning implementation, verifying the implementation, and closing the change request once complete.
This document summarizes the objectives and classification system of the Global Harmonization Task Force (GHTF) for in vitro diagnostic (IVD) medical devices. The GHTF was founded in 1993 to harmonize medical device regulations globally. It aims to facilitate trade while preserving public health. IVD medical devices are classified into 4 risk-based classes (A to D) based on 16 general rules related to device invasiveness, energy use, and disease detection. Class A devices pose the lowest risk while Class D the highest. The classification system aims to ensure regulatory oversight is proportionate to device risk.
The document defines FDA warning letters and describes the process of FDA inspections that can lead to warning letters. It explains that warning letters notify companies of violations found during inspections and investigations. Companies must promptly correct issues and FDA will check that corrections are adequate. The document also describes different types of warning letters for various regulated industries and how to browse existing warning letters on the FDA website.
Product registration and drug approval process in uskeerthi09
The document summarizes the key aspects of the new drug application (NDA) and abbreviated new drug application (ANDA) processes in the United States. It describes the requirements for NDAs, including the 20 sections that make up an NDA and the information contained within them. It also discusses ANDA requirements for generic drugs, such as bioequivalence studies and patent certifications that are part of the review process. The review processes for both NDAs and ANDAs by the FDA are also briefly outlined.
Center for Biologics Evaluation and ResearchRajeswariS12
The Center for Biologics Evaluation and Research (CBER) is one of six main centers of the US Food and Drug Administration that regulates biological products intended for human use. CBER is responsible for ensuring the safety, purity, potency, and effectiveness of biologics such as vaccines, blood products, cell and gene therapies. It oversees the testing, licensing, and post-market monitoring of these products. CBER staff review clinical trial data submitted in Biologics License Applications to determine if a biologic is safe and effective before approval.
The document discusses the ASEAN Common Technical Dossier (ACTD) format for pharmaceutical product registration applications submitted to ASEAN regulatory authorities. The ACTD format aims to standardize applications to reduce submission time and resources while facilitating regulatory review. It includes four parts covering administrative data, quality, nonclinical, and clinical information. The ACTD guideline describes the sections within each part, including overviews, summaries, study reports, and references. The standard format seeks to provide a consistent and transparent presentation of technical information to support evaluation and understanding of registration applications.
Process validation establishes documented evidence that a manufacturing process will consistently produce products meeting specifications. It involves qualifying facilities and equipment, validating critical process parameters, and revalidating when changes occur. Validation includes prospective validation of new processes and retrospective validation of existing stable processes by statistical analysis of historical batch data. Documentation of the validation master plan, protocols, reports, and results provide assurance that processes are properly controlled.
The document discusses guidelines from the International Conference on Harmonization (ICH) related to quality and specifications of pharmaceutical products. It describes several ICH Q guidelines including Q1 on stability testing, Q2 on analytical method validation, Q3 on impurities, Q4 on pharmacopoeial harmonization, and Q5 on biotechnological/biological products. Key points covered include requirements for stability testing protocols, validation of analytical methods, identification and qualification of impurities, harmonization of pharmacopoeial standards, and viral safety evaluation of cell-derived biopharmaceuticals.
Abriviated new drug application 505(j) fillingshahnawazQuadir
An abbreviated new drug application (ANDA) allows generic drug manufacturers to file for FDA approval of a generic drug. The ANDA relies on the safety and efficacy data of an approved innovator drug and must demonstrate bioequivalence through bioavailability/bioequivalence studies. There are different types of ANDA applications including Paragraph I, II, III, and IV, with Paragraph IV applications being used when a generic applicant is attempting to enter the market before patent expiration by claiming the patents are invalid or would not be infringed by the generic product. The ANDA review process involves a 30 month stay if the innovator sues for patent infringement within 45 days, during which time the first approved generic receives 180 days of market
regulatory approval process of drug, cosmetic and herbals in canada Richa Patel
The document discusses the regulatory approval process for drugs, cosmetics, nutraceuticals, and herbal products in Canada. It provides details on:
1) How drugs are reviewed and authorized for sale once they have undergone assessment by Health Canada for safety, efficacy, and quality.
2) The roles and responsibilities of the Health Products and Food Branch in regulating therapeutic and diagnostic products in Canada.
3) The definitions of key terms like drugs, cosmetics, natural health products, and personal care products according to Canadian regulations.
The document summarizes regulatory considerations for pharmaceuticals in Japan, including manufacturing, packaging, labeling, and post-marketing surveillance. For manufacturing, drugs must be approved by the Ministry of Health, Labor and Welfare and manufacturers must be licensed and follow good manufacturing practices. Packaging and labeling must contain specified information and any changes require relabeling. Post-marketing surveillance involves adverse event reporting, drug reexaminations every few years to reconfirm safety and efficacy, and reevaluations based on current medical knowledge.
The document provides guidelines for handling out of specification test results as outlined by the USFDA. It defines an out of specification result as one that falls outside the defined test limits. It discusses the USFDA's OOS guidelines published in 2006 and notes that quality units should have a defined SOP for addressing OOS results. The SOP scope should be well defined and investigations into OOS results should be thorough, timely, unbiased, well documented, and scientifically sound. Laboratory investigations should check for errors and, if none are found, a phase II investigation including retesting and investigation at the plant may be initiated. Tools like 5M, 5 whys, DMAIC and root cause analysis should be used to identify
This document provides an introduction to auditing and the audit process. It defines an audit as the on-site verification of a process or quality system to ensure compliance. Audits can be conducted internally or externally according to ICH guidelines. The objectives of an audit are to determine conformity or nonconformity with quality systems and to improve quality. Pharmaceutical manufacturers use GMP audits to verify manufacturing controls and permit timely problem correction. Management audits comprehensively examine an organization. Audits can be first, second, or third party. An auditor's responsibilities include providing audit reports and identifying issues. The planning process for an audit involves announcing a schedule, conducting meetings, performing the audit, and providing follow-up.
1. The PMDA (Pharmaceuticals and Medical Devices Agency) is the Japanese regulatory agency that reviews submissions for drug and medical device approval to ensure safety, efficacy, and quality. It was established in 2004.
2. To market a drug in Japan, approval must be obtained for each product by demonstrating efficacy and safety through examinations. Foreign manufacturers must be accredited through the FMA process. Medical devices are classified and require pre-market notification, certification, or approval depending on the risk class.
3. Registering products in Japan requires navigating a complex process that can involve clinical trials and high fees. Pursuing product registration requires carefully considering the market demand to determine if pursuing approval is worthwhile.
The document discusses out-of-specification (OOS) test results and the process for investigating them. OOS results occur when analytical results fall outside established specification ranges. There are guidelines from organizations like MHRA, CDER, and PIC/S for handling OOS products. Investigations of OOS results involve a Phase I laboratory investigation and may proceed to Phase II and III manufacturing investigations. The goal is to determine the root cause and decide if corrective actions can resolve the issue or if the batch must be rejected.
An out of specification (OOS) occurs when analytical results fall outside established specification ranges. There are guidelines from organizations like MHRA, CDER, and PIC/S for handling OOS events. OOS can occur during stability studies, finished products, or raw materials due to laboratory errors, process issues, or sample homogeneity problems. Investigations follow a phased approach starting with the quality control laboratory and then involving manufacturing operations if needed. The fate of an OOS batch may include reprocessing, reworking, or destruction depending on the investigation conclusions.
This document discusses procedures for investigating out-of-specification or atypical laboratory test results. It defines key terms like out-of-specification, out-of-trend, and atypical results. It also outlines a two-phase investigation process conducted by analysts and supervisors to identify potential errors or assignable causes for the results. If no error or cause is found, a more thorough investigation involving production and quality personnel is required. Checklists are provided to guide the analysts' and supervisors' review of methodology, equipment, standards, and other potential factors.
This document discusses out of specification (OOS) results and the processes for investigating them. It covers:
1) What OOS is and when investigations are conducted.
2) The initial laboratory investigation and the responsibilities of the analyst and supervisor.
3) Full-scale investigations which include reviewing manufacturing, production, sampling, and initial lab results.
4) Supplementary laboratory testing like re-testing and re-sampling to identify the source of errors.
5) Analyzing the investigated results to determine the possible causes of OOS results.
This document provides guidance on investigating out of specification or out of trend results from laboratory analyses. It describes a multi-step investigation process including: Phase Ia investigations to identify obvious errors; Phase Ib investigations conducted by an analyst and supervisor using a checklist to identify potential causes; Phase II investigations if no cause is found that may involve additional parties; and Phase III investigations and batch disposition if needed. Key terms related to investigations are also defined, such as out of specification, out of trend, assignable cause, and invalidated test.
It is difficult to maintain the sterility and It is more difficult to investigate when the status is Non sterile. So this ppt narrate the way for you to investigate the Non sterility.
Good Laboratory Practice (GLP) guidelines provide standards for laboratory experiments and tests performed to support research, nonclinical studies, and regulatory submissions. The key goals of GLP are to ensure quality, reliability, and integrity of data through adherence to standard operating procedures, trained personnel, appropriate facilities and equipment, records management, and quality control. GLP aims to promote valid and robust research that can be reproduced internationally and supports regulatory review and decision making.
The document outlines the process for investigating out-of-specification (OOS), out-of-trend (OOT), or atypical test results. It involves a multi-phase investigation including:
Phase I involves an initial laboratory investigation to identify any errors. Phase II is a full-scale investigation including manufacturing process review, additional laboratory testing through retesting or resampling, and identification of any assignable causes. Phase III ensures corrective and preventative actions are taken as needed and other potentially impacted batches are evaluated. The goal is to thoroughly investigate to determine if the batch should be rejected or can be released and prevent future occurrences.
U.S.F.D.A. was the pioneer in the concept of process validation.
Validation had proven to be an important tool for quality management of pharmaceutical according to ISO 9000:2000.
U.S.F.D.A. was the pioneer in the concept of process validation.
Validation had proven to be an important tool for quality management of pharmaceutical according to ISO 9000:2000.
The document discusses Good Laboratory Practice (GLP), which are quality standards that regulate the conduct of laboratory studies related to health and safety. It provides background on GLP, including that GLP was created by the FDA in the 1970s in response to cases of fraudulent laboratory practices. The key objectives of GLP are to ensure study data is accurate, traceable, and promotes international acceptance of tests. GLP establishes requirements for facilities, equipment, personnel, methods, records, and quality assurance programs. Laboratories must adhere to GLP in order to produce reliable results for regulatory submissions.
The document discusses Good Laboratory Practice (GLP), which are quality standards that regulate the conduct of laboratory studies related to health and safety. It provides background on GLP, explaining that GLP was created by the FDA in the 1970s after investigations found fraudulent activities and poor practices in toxicology labs. The objectives of GLP are to ensure data submitted are an accurate reflection of study results and that data is traceable. GLP provides a framework for planning, conducting, monitoring, recording and reporting laboratory studies while maintaining quality assurance.
The document discusses Good Laboratory Practice (GLP), which are quality standards that regulate the conduct of laboratory studies related to health and safety. It provides background on GLP, including that GLP was created by the FDA in the 1970s in response to cases of fraudulent laboratory practices. The key objectives of GLP are to ensure laboratory study data is accurate, traceable, and can be relied upon for regulatory decision making. GLP establishes requirements for facilities, equipment, personnel, methods, records, and management to ensure the integrity of all safety data generated during nonclinical health and environmental safety studies.
The document discusses Good Manufacturing Practices (GMP) with a focus on quality control. It outlines key aspects of GMP compliance that should be reviewed during an on-site quality control laboratory inspection, including documentation, personnel qualifications, equipment and instrument validation, testing procedures, data verification, and facilities and environmental monitoring. The inspection aims to ensure proper implementation of quality standards and systems across all aspects of the quality control process.
GLP (Good Laboratory Practice) is a quality system with defined standards for conducting studies and reporting results. It ensures uniformity, consistency, reliability and reproducibility of testing through elements like SOPs, personnel roles, equipment validation and laboratory safety practices. Key aspects of GLP include establishing an independent quality assurance unit, documenting all study activities, ensuring personnel are qualified and equipment is properly maintained and calibrated, and archiving records for a defined period of time. Following GLP helps provide reasonable assurance that study results were collected as outlined and can be relied upon, even if it does not guarantee the scientific merit of the study itself.
This document discusses guidelines and best practices for handling out-of-specification (OOS) analytical results. It outlines procedures that regulatory agencies like the FDA recommend for investigating OOS results, including performing a preliminary assessment, full laboratory investigation, and documenting findings. The document emphasizes that OOS results should not be invalidated without a thorough investigation to identify the root cause and prevent future errors.
Documentation with respect to release of finished pharmaceutical productMadhuraNewrekar
Documentation is a crucial part of the quality assurance system and is needed in every aspect of pharmaceutical manufacturing. Important documentation with respect to final product release in pharmaceutical industry is explained in brief.
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.
Gender and Mental Health - Counselling and Family Therapy Applications and In...PsychoTech Services
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!
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
Communicating effectively and consistently with students can help them feel at ease during their learning experience and provide the instructor with a communication trail to track the course's progress. This workshop will take you through constructing an engaging course container to facilitate effective communication.
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!"
Temple of Asclepius in Thrace. Excavation resultsKrassimira Luka
The temple and the sanctuary around were dedicated to Asklepios Zmidrenus. This name has been known since 1875 when an inscription dedicated to him was discovered in Rome. The inscription is dated in 227 AD and was left by soldiers originating from the city of Philippopolis (modern Plovdiv).
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.)
Traditional Musical Instruments of Arunachal Pradesh and Uttar Pradesh - RAYH...
OUT OF SPECIFICATIONS (OOS).pptx
1. GOOD REGULATORY PRACTICES
(MRA 101T)
UNIT – V
OUT OF SPECIFICATIONS (OOS)
MOHAMED FAZIL M
P1821003
M.PHARM – 1st SEM
REGULATORY AFFAIRS
MOB: 8870884215
2. OUT OF SPECIFICATIONS (OOS)
Out of Specification (OOS) means the result that falls
outside the specifications or acceptance criteria which has been
specified in the official compendia monographs or the finished
product specifications in the registration dossiers.
The analytical result(s) of a batch or material is/are
falling out side of the established specification ranges,
considered as Out of Specification.
The term OOS test results includes all suspect results
that fall outside the predetermined Specification.
3. There are lot of guidelines are available for
defining to handle the products/materials/batches
as:
•
• MHRA guideline for OOS
• CDER guideline for OOS
• PIC/S guideline for OOS
4. The OOS may be observed during the
analysis of:
Stability study
Finished API
Intermediates
In-process
Raw materials
Packing materials
5. OOS found due to the following reasons but not
limited to:
Laboratory
Process related
Sample homogeneity
6. LABORATORY ERRORS
Method of analysis
Use of Non calibrated
instruments
Error in calculation
Analyst error
Instrument failure
7. PROCESS RELATED
Operator Error
Equipment Failure
Deviation form the Validated procedure
Quality of Raw material / Intermediate
used
In-Process Control During
Manufacturing
9. PROCEDURES OF OOS
INVESTIGATIONS
As per MHRA (EU GMP)
Phase - I
Investigation (Primary & extended
lab investigation)
Phase-II
Investigation (Manufacturing
investigation)
Phase–III
Investigation (Extended
manufacturing, Re-sampling and re-
analysis)
10. As per CDER (US FDA)
Phase-I
Investigation (Primary & extended lab
investigation)
Phase- II
Investigation (Manufacturing
investigation and resampling and re-
analysis)
11. As per MHRA (EU GMP)
Phase - I Investigation: Laboratory investigation
Laboratory investigation is related to
the Quality control department along with rechecking of
document with the analyst and re-testing with different
analyst with original sample
Phase -I is sub divided in to two sections as
Phase- Ia (Primary Lab investigation)
Phase -Ib (Extended Lab investigation)
12. As per MHRA (EU GMP)
Phase-II Investigation: Manufacturing
Investigations
In manufacturing investigation production
person investigate:
Process parameters
Drying parameters
Input raw materials quality
Training of persons
Cleaning of equipment
Environmental information
Contamination & etc..
13. Phase – III Investigtion Extended
Manufacturing Investigations
In Phase III investigation, Quality Control /
Quakity Assurance & Production department
investigate the following:
• Sampling error by person
• Authorized for re-sampling (if required)
• Re-analysis of re-sampled material with different
analyst
• If root cause found, define the CAPA or if not
• Diverted the matter to R&D / ADL or PD Lab
• Conclusion by all team member (QA, QC, PRD,
ADL, R&D, PD Lab)
• Decide the fate of batch by QA Head
14. RE-TESTING:
The analysis of
original sample
at the time of
phase - I
laboratory
investigation.
RE-SAMPLING:
The original
batch is
sampled by QA
second time
after QA head
authorization
for reanalysis.
RE-ANALYSIS:
The analysis of
re-sampled
material for the
verification of
results, if
manufacturing
investigation
does not have
root cause.
15. AS PER CDER (US FDA)
Phase - I Investigation: Laboratory investigation
Laboratory investigation is related to the Quality
control department along with rechecking of documents
with same analyst and re-testing with different analyst
with original sample.
Phase- II Investigation: Manufacturing investigation
Process related investigation is to be carried out
by Production department along with re-sampling &
reanalysis.
16. Phase - I Investigation: Laboratory
investigation
• Analyst observed the OOS result
• Re-calculate the results (if required)
• If analytical results remain same
• Report the OOS result to QC In-
charge
• Log the OOS
• Start the Primary Laboratory
investigation
• Review the documents along with
solutions as (Potency / STP & Specs
solutions / Column efficiency /
weights / storage condition of sample
and many more)
17. If there is no abnormality observed during the primary lab investigation then
Report same results and considered as valid O0S and report
Quality Head review the primary lab investigation and evaluate for re- testing (if QA Head
permits)
Repeat the analysis as thrice with original sample with different analyst
Report the average result of repeat analysis
Report the average result
18. If the result complies
• Report as complies and invalidate the OOS
• Release the batch
If any of result if not complies (among three )
• Report as OOS and continue the OOS
• Report to QA Head
QA head will recommend for the Phase - II investigation
(manufacturing investigation)
19. Phase II Investigation: Manufacturing investigation
• Input quantity of raw material
• Input RM quality
• Process parameters details
• Critical process parameter details (time / temp)
• In-process results
• Out put of the material
• Re-conciliation of raw materials
• Utility pressures
• Calibration/ Preventive maintenance of equipment
• Attached ancillaries status
Production persons shall investigate the following:
20. PRODUCTION PERSONS SHALL INVESTIGATE THE
FOLLOWING:
Cleaning of equipments
Training of personnel
Brain storming with operators
Contamination verifications
Environmental review
If there is no assignable cause observed during manufacturing investigations, same
is to be reported to Quality Assurance Head.
21. Phase-II Investigation: Manufacturing
investigation
QA, QC and production department
will evaluate nvestigations and after
that:
• Sampling procedure review, if suspected
• QA head may recommend for re-sampling
• QC analyst shall analyze the sample as per STP
• Report the result ( pass/ failed)
22. • Define the CAPA
• Release the Batch If failed
If Pass
• Reject the batch
• Divert the matter to R&D/ADL / PD Lab
If failed
23. R&D/ADL / PD LAB SHALL:
Take the user trial with the material
Investigate the failure based on experiments /experiences
Various types of experiments
To find out the root cause
To identify, is this material can be reprocessed / reworked
Make a summary report
Defined the corrective actions
24. QA/QC/PRODUCTION DEPARTMENT SHALL:
QA head shall define the fate of batch for reprocess / rework destruction
Accept the corrective and preventive actions
Training to all concerned for root cause corrective action preventive action
Monitor the activity of corrective action
25. Evaluate the results of corrective actions
Implement the preventive actions
Verify the implementation of preventive actions
After satisfactory implementation close the OOS & CAPA
All these activity for investigation / corrective actions preventive
actions should be recorded and reviewed and archived
26. IF OOS BATCH IS TO BE REPROCESSED / RE-
WORK:
Follow the written approved BMR for re-
process /Rework
Sample as per SOP for sampling of material
Analyze the material according to the
specification and STP
Evaluate the quality of the batch
27. •
• Keep this batch for stability
(Accelerated / Long term)
Evaluate the stability results of the
batch
Communicate the OOS to the
customers (as mentioned in to the Quality
agreement)
IMPACT OF ON REGULATORY
Stability study required
OOS should be reported to RA
OOS batch should not be sold regulatory
market
OOS batch can not be blend with fresh
approved batch
OOS batch can not be directly sell to the
market
•