The document provides guidance on conducting Annual Product Reviews (APRs), including:
- APRs are required annually for commercial products to verify consistency, assess trends, determine specification/process changes, and evaluate revalidation needs.
- APRs must include review of batches manufactured, deviations, complaints, recalls, changes, specifications, validation status, and trend analyses. Additional requirements may apply from local regulations.
- The review concludes if the product consistently meets quality attributes and necessary corrective actions. APRs communicate between manufacturing, quality, and regulatory to enable quality improvement.
The document discusses the requirements and procedures for conducting an Annual Product Quality Review (APQR). Key points include:
- The APQR is intended to verify process consistency, assess trends, determine needed specification/procedure changes, and evaluate revalidation needs.
- Regulatory guidelines like ICH Q7, FDA, and EU require annual reviews that include batch data, deviations, complaints, stability results, and corrective actions.
- The quality unit coordinates the APQR using data and participation from other departments. The review is documented and approved by senior quality management.
The document provides information about auditing a microbiological laboratory. It defines quality audits and outlines the scope and objectives of auditing. Key areas that are audited include laboratory equipment, standard operating procedures, documentation, environmental monitoring, and testing processes. The document discusses auditing the laboratory facility, equipment, documentation systems, and testing methods to ensure compliance with standards.
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.
Annual product reviews are conducted annually to assess the quality of drug products and determine if any changes need to be made to product specifications, manufacturing processes, or quality control procedures. The review evaluates analytical data, inspection results, batch failures, complaints, recalls, deviations, stability monitoring results, and corrective actions to verify process consistency and identify quality trends over time. The goal is to continually improve product quality and manufacturing processes.
This document discusses vendor certification and categorization. It defines vendor certification as ensuring a vendor will meet regulatory expectations. Vendors are categorized from 1 to 4 based on risk, with category 1 being experts with minimal monitoring and category 4 being sole-source API manufacturers requiring intense monitoring. The document also outlines the vendor qualification process, including selection criteria, evaluation of production processes, and standard procedures for quality audits.
This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products and may also be used as supplementary optional guidance for active substances without introduction of additional requirements to EudraLex, Volume 4, Part II. It is a GMP requirement that manufacturers control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process. Any planned changes to the facilities, equipment, utilities and processes, which may affect the quality of the product, should be formally documented and the impact on the validated status or control strategy assessed. Computerised systems used for the manufacture of medicinal products should also be validated according to the requirements of Annex 11. The relevant concepts and guidance presented in ICH Q8, Q9, Q10 and Q11 should also be taken into account.
Highlights of the guidance are given in following presentation.
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.
The document discusses the requirements and procedures for conducting an Annual Product Quality Review (APQR). Key points include:
- The APQR is intended to verify process consistency, assess trends, determine needed specification/procedure changes, and evaluate revalidation needs.
- Regulatory guidelines like ICH Q7, FDA, and EU require annual reviews that include batch data, deviations, complaints, stability results, and corrective actions.
- The quality unit coordinates the APQR using data and participation from other departments. The review is documented and approved by senior quality management.
The document provides information about auditing a microbiological laboratory. It defines quality audits and outlines the scope and objectives of auditing. Key areas that are audited include laboratory equipment, standard operating procedures, documentation, environmental monitoring, and testing processes. The document discusses auditing the laboratory facility, equipment, documentation systems, and testing methods to ensure compliance with standards.
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.
Annual product reviews are conducted annually to assess the quality of drug products and determine if any changes need to be made to product specifications, manufacturing processes, or quality control procedures. The review evaluates analytical data, inspection results, batch failures, complaints, recalls, deviations, stability monitoring results, and corrective actions to verify process consistency and identify quality trends over time. The goal is to continually improve product quality and manufacturing processes.
This document discusses vendor certification and categorization. It defines vendor certification as ensuring a vendor will meet regulatory expectations. Vendors are categorized from 1 to 4 based on risk, with category 1 being experts with minimal monitoring and category 4 being sole-source API manufacturers requiring intense monitoring. The document also outlines the vendor qualification process, including selection criteria, evaluation of production processes, and standard procedures for quality audits.
This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products and may also be used as supplementary optional guidance for active substances without introduction of additional requirements to EudraLex, Volume 4, Part II. It is a GMP requirement that manufacturers control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process. Any planned changes to the facilities, equipment, utilities and processes, which may affect the quality of the product, should be formally documented and the impact on the validated status or control strategy assessed. Computerised systems used for the manufacture of medicinal products should also be validated according to the requirements of Annex 11. The relevant concepts and guidance presented in ICH Q8, Q9, Q10 and Q11 should also be taken into account.
Highlights of the guidance are given in following presentation.
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.
The document discusses the requirements and procedures for conducting an Annual Product Quality Review (APQR). It states that APQRs are required by regulatory agencies to verify process consistency, assess trends, determine needed specification or production changes, and evaluate revalidation needs. They help ensure quality standards are met and facilitate communication between manufacturing, quality, and regulatory functions. The document outlines the responsibilities, key activities, data requirements, and documentation involved in properly conducting an APQR.
The document summarizes ICH Q10, which provides a harmonized model for a pharmaceutical quality system throughout the lifecycle of a product. It describes the contents and sections of ICH Q10, including management responsibility, continual improvement of process performance and product quality, and continual improvement of the pharmaceutical quality system. The goal is to establish an effective quality management system for the pharmaceutical industry and enhance the quality and availability of medicines.
In this slide contains definition, importance, benefits of annual product review.
Presented by: Ravi Sanker babu .D.V (Department of pharmaceutical analysis and quality assurance).
RIPER, anantapur.
The document outlines requirements and guidelines for conducting an Annual Product Review (APR). Key points include:
- An APR must be conducted annually for each commercial product to assess consistency, trends, needed changes, and revalidation. It involves multiple departments and communication between manufacturing, quality, and regulatory affairs.
- The APR scope covers manufacturing sites, affiliates, and subcontractors. It must include production statistics, deviations, complaints, recalls, changes, process validation status, trend analysis, and recommendations.
- The results are evaluated to determine if corrective or preventative actions are needed. Senior management from quality and production must approve the APR, which is then archived for audits. Checklists are
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with qualifications of HPLC which is the " High Performance Liquid Chromatography".
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
The Role of Regulatory GMP Audit in Pharmaceutical Companies.Jitendra Sonawane
This document discusses the role of regulatory GMP audits in pharmaceutical companies. It begins by defining auditing as an evaluation used to determine the effectiveness of quality controls. Regulatory agencies require internal audits to ensure compliance with cGMP regulations. The objectives of auditing are to determine conformity and effectiveness of quality systems. Audits are important for compliance, problem detection, and assessing control systems. The document outlines standard audit procedures, classifications, types of auditors, and the 10 step auditing process used in the pharmaceutical industry.
This document provides an overview of validation in the pharmaceutical industry. It defines validation as a documented program that ensures a process will consistently produce a product meeting predetermined specifications. The document discusses the importance of validation in assuring quality and reducing costs. It outlines the scope of validation, which covers all aspects influencing quality from product design to storage. Prospective, concurrent and retrospective validation approaches are described. The organization of a validation group with representatives from relevant departments is also presented.
The document discusses product quality reviews, which are periodic reviews of authorized medicinal products to verify consistency of processes, appropriateness of specifications, and identify improvements. They are required by regulatory authorities and involve multiple departments. The summary includes:
1) Product quality reviews verify consistency of manufacturing processes and specifications for raw materials and finished products, identify trends, and highlight areas for improvement.
2) They are required by regulatory authorities to ensure ongoing product quality and involve departments across manufacturing, quality assurance, and regulatory affairs.
3) The reviews analyze manufacturing data, complaints, deviations, and changes over a one year period to determine if processes are in control and capable of meeting requirements.
Documentation in Pharmaceutical Industry Part I Tarif Hussian
This document discusses documentation practices in the pharmaceutical industry. It provides definitions of key terms like documentation and good documentation practices. It also describes important pharmaceutical documents like those related to drug substance, drug product, and exploratory product development briefs. These documents provide information on development, manufacturing, testing, and controls of drugs to ensure their quality, safety and efficacy. Adherence to documentation standards like ALCOA and ALCOA+ helps ensure the integrity and reliability of data in the pharmaceutical industry.
This document provides an overview of qualification and validation principles according to Good Manufacturing Practices (GMP). It defines qualification and validation, and explains their scope, principles, types of documentation, and importance. Qualification and validation provide documented evidence that critical aspects of manufacturing are controlled. The document outlines the key elements that should be addressed in a validation master plan, protocol, and report. It also discusses new approaches to validation including risk assessment and a three-phase process design.
This document outlines the requirements for factory premises manufacturing medical devices according to Schedule M-III of the Drugs and Cosmetics Rules 1945 in India. It discusses location, building, water supply, waste disposal, worker hygiene and medical facilities requirements. It also provides recommendations for equipment and space needed for manufacturing common medical devices like perfusion sets, syringes and needles. Manufacturers must follow good manufacturing practices and maintain processing and quality control records. Medical devices are classified based on risk into four classes from low to high risk.
1. ICH Q7 provides guidance for good manufacturing practices for manufacturing active pharmaceutical ingredients. It is intended to help ensure APIs meet quality and purity requirements.
2. The guidelines apply to all stages of API manufacturing, including receiving, production, packaging, testing and distribution. It covers APIs made through chemical synthesis, extraction, fermentation and other processes.
3. The guidelines address requirements for facilities, equipment, personnel, documentation, materials management, production controls, validation, complaints and recalls to ensure quality management.
The document discusses change control procedures for pharmaceutical quality systems. It states that a formal change control system should be established to evaluate all changes that could affect production or quality. Changes should be properly identified, documented, reviewed, approved and implemented. Quality risk management should be used to evaluate planned changes and determine their potential impact. Changes require authorization and approval according to the quality system. The effectiveness of changes should be evaluated after implementation.
The document discusses current Good Manufacturing Practices (cGMP) according to the US Food and Drug Administration (FDA). It provides an overview of cGMP principles and requirements, including proper facilities and equipment design, documentation practices, and quality control. The document also summarizes key cGMP regulations and guidelines for manufacturing, processing, packaging, holding, testing, and distributing drug products. It outlines the important documents, facilities, equipment, production processes, and quality systems that must be in place to ensure consistent production of safe, effective pharmaceuticals.
This document provides an overview of corrective and preventive action (CAPA) requirements for medical device manufacturers. It discusses the purpose and context of the CAPA subsystem, when FDA reviews CAPAs, definitions, the CAPA process, procedures, data analysis, investigations, identifying required actions, and verifying the effectiveness of actions without adversely affecting the device. The key points are that CAPA is important for ensuring problems are detected and resolved, linked to other quality system requirements, and involves analyzing data, investigating causes, identifying appropriate corrective or preventive actions, and validating their effectiveness.
The audit examines the HVAC system and building by analyzing energy consumption, reviewing equipment and controls, assessing ventilation and lighting, identifying safety issues, and calculating heat loss/gain. Key components like the furnace, evaporator coil, ductwork, and vents are inspected. The goal is to improve efficiency and indoor air quality by evaluating utility usage, potential upgrades, and routine testing procedures for compressed gases and utilities in contact with products.
Product Quality Reviews (PQRs) are conducted annually to review manufacturing processes, specifications, trends, and identify improvements for pharmaceutical products. PQRs can be done on individual products, grouped products, or through exception reviews. The objective is to verify consistency, specifications, identify trends, and improvements. PQRs provide information on processes, quality requirements, and release decisions. Outcomes are used to identify continuous quality improvements through action plans. Manufacturers are responsible for preparing review data and lists, while reviews consider starting materials, specifications, failures, deviations, changes, variations, stability, complaints, and contractual arrangements.
The Product Quality Review (PQR) is a regular review of all licensed medicinal products conducted to verify consistency of manufacturing processes and the appropriateness of specifications. The objectives of the PQR include determining the need for process, specification or validation changes; verifying compliance; identifying trends; and determining corrective actions. The EU requires annual PQRs that review areas like starting materials, process and product testing results, failed batches, deviations, changes made, and stability monitoring results. The PQR is intended to enhance quality and identify improvements.
The document discusses the requirements and procedures for conducting an Annual Product Quality Review (APQR). It states that APQRs are required by regulatory agencies to verify process consistency, assess trends, determine needed specification or production changes, and evaluate revalidation needs. They help ensure quality standards are met and facilitate communication between manufacturing, quality, and regulatory functions. The document outlines the responsibilities, key activities, data requirements, and documentation involved in properly conducting an APQR.
The document summarizes ICH Q10, which provides a harmonized model for a pharmaceutical quality system throughout the lifecycle of a product. It describes the contents and sections of ICH Q10, including management responsibility, continual improvement of process performance and product quality, and continual improvement of the pharmaceutical quality system. The goal is to establish an effective quality management system for the pharmaceutical industry and enhance the quality and availability of medicines.
In this slide contains definition, importance, benefits of annual product review.
Presented by: Ravi Sanker babu .D.V (Department of pharmaceutical analysis and quality assurance).
RIPER, anantapur.
The document outlines requirements and guidelines for conducting an Annual Product Review (APR). Key points include:
- An APR must be conducted annually for each commercial product to assess consistency, trends, needed changes, and revalidation. It involves multiple departments and communication between manufacturing, quality, and regulatory affairs.
- The APR scope covers manufacturing sites, affiliates, and subcontractors. It must include production statistics, deviations, complaints, recalls, changes, process validation status, trend analysis, and recommendations.
- The results are evaluated to determine if corrective or preventative actions are needed. Senior management from quality and production must approve the APR, which is then archived for audits. Checklists are
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with qualifications of HPLC which is the " High Performance Liquid Chromatography".
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
The Role of Regulatory GMP Audit in Pharmaceutical Companies.Jitendra Sonawane
This document discusses the role of regulatory GMP audits in pharmaceutical companies. It begins by defining auditing as an evaluation used to determine the effectiveness of quality controls. Regulatory agencies require internal audits to ensure compliance with cGMP regulations. The objectives of auditing are to determine conformity and effectiveness of quality systems. Audits are important for compliance, problem detection, and assessing control systems. The document outlines standard audit procedures, classifications, types of auditors, and the 10 step auditing process used in the pharmaceutical industry.
This document provides an overview of validation in the pharmaceutical industry. It defines validation as a documented program that ensures a process will consistently produce a product meeting predetermined specifications. The document discusses the importance of validation in assuring quality and reducing costs. It outlines the scope of validation, which covers all aspects influencing quality from product design to storage. Prospective, concurrent and retrospective validation approaches are described. The organization of a validation group with representatives from relevant departments is also presented.
The document discusses product quality reviews, which are periodic reviews of authorized medicinal products to verify consistency of processes, appropriateness of specifications, and identify improvements. They are required by regulatory authorities and involve multiple departments. The summary includes:
1) Product quality reviews verify consistency of manufacturing processes and specifications for raw materials and finished products, identify trends, and highlight areas for improvement.
2) They are required by regulatory authorities to ensure ongoing product quality and involve departments across manufacturing, quality assurance, and regulatory affairs.
3) The reviews analyze manufacturing data, complaints, deviations, and changes over a one year period to determine if processes are in control and capable of meeting requirements.
Documentation in Pharmaceutical Industry Part I Tarif Hussian
This document discusses documentation practices in the pharmaceutical industry. It provides definitions of key terms like documentation and good documentation practices. It also describes important pharmaceutical documents like those related to drug substance, drug product, and exploratory product development briefs. These documents provide information on development, manufacturing, testing, and controls of drugs to ensure their quality, safety and efficacy. Adherence to documentation standards like ALCOA and ALCOA+ helps ensure the integrity and reliability of data in the pharmaceutical industry.
This document provides an overview of qualification and validation principles according to Good Manufacturing Practices (GMP). It defines qualification and validation, and explains their scope, principles, types of documentation, and importance. Qualification and validation provide documented evidence that critical aspects of manufacturing are controlled. The document outlines the key elements that should be addressed in a validation master plan, protocol, and report. It also discusses new approaches to validation including risk assessment and a three-phase process design.
This document outlines the requirements for factory premises manufacturing medical devices according to Schedule M-III of the Drugs and Cosmetics Rules 1945 in India. It discusses location, building, water supply, waste disposal, worker hygiene and medical facilities requirements. It also provides recommendations for equipment and space needed for manufacturing common medical devices like perfusion sets, syringes and needles. Manufacturers must follow good manufacturing practices and maintain processing and quality control records. Medical devices are classified based on risk into four classes from low to high risk.
1. ICH Q7 provides guidance for good manufacturing practices for manufacturing active pharmaceutical ingredients. It is intended to help ensure APIs meet quality and purity requirements.
2. The guidelines apply to all stages of API manufacturing, including receiving, production, packaging, testing and distribution. It covers APIs made through chemical synthesis, extraction, fermentation and other processes.
3. The guidelines address requirements for facilities, equipment, personnel, documentation, materials management, production controls, validation, complaints and recalls to ensure quality management.
The document discusses change control procedures for pharmaceutical quality systems. It states that a formal change control system should be established to evaluate all changes that could affect production or quality. Changes should be properly identified, documented, reviewed, approved and implemented. Quality risk management should be used to evaluate planned changes and determine their potential impact. Changes require authorization and approval according to the quality system. The effectiveness of changes should be evaluated after implementation.
The document discusses current Good Manufacturing Practices (cGMP) according to the US Food and Drug Administration (FDA). It provides an overview of cGMP principles and requirements, including proper facilities and equipment design, documentation practices, and quality control. The document also summarizes key cGMP regulations and guidelines for manufacturing, processing, packaging, holding, testing, and distributing drug products. It outlines the important documents, facilities, equipment, production processes, and quality systems that must be in place to ensure consistent production of safe, effective pharmaceuticals.
This document provides an overview of corrective and preventive action (CAPA) requirements for medical device manufacturers. It discusses the purpose and context of the CAPA subsystem, when FDA reviews CAPAs, definitions, the CAPA process, procedures, data analysis, investigations, identifying required actions, and verifying the effectiveness of actions without adversely affecting the device. The key points are that CAPA is important for ensuring problems are detected and resolved, linked to other quality system requirements, and involves analyzing data, investigating causes, identifying appropriate corrective or preventive actions, and validating their effectiveness.
The audit examines the HVAC system and building by analyzing energy consumption, reviewing equipment and controls, assessing ventilation and lighting, identifying safety issues, and calculating heat loss/gain. Key components like the furnace, evaporator coil, ductwork, and vents are inspected. The goal is to improve efficiency and indoor air quality by evaluating utility usage, potential upgrades, and routine testing procedures for compressed gases and utilities in contact with products.
Product Quality Reviews (PQRs) are conducted annually to review manufacturing processes, specifications, trends, and identify improvements for pharmaceutical products. PQRs can be done on individual products, grouped products, or through exception reviews. The objective is to verify consistency, specifications, identify trends, and improvements. PQRs provide information on processes, quality requirements, and release decisions. Outcomes are used to identify continuous quality improvements through action plans. Manufacturers are responsible for preparing review data and lists, while reviews consider starting materials, specifications, failures, deviations, changes, variations, stability, complaints, and contractual arrangements.
The Product Quality Review (PQR) is a regular review of all licensed medicinal products conducted to verify consistency of manufacturing processes and the appropriateness of specifications. The objectives of the PQR include determining the need for process, specification or validation changes; verifying compliance; identifying trends; and determining corrective actions. The EU requires annual PQRs that review areas like starting materials, process and product testing results, failed batches, deviations, changes made, and stability monitoring results. The PQR is intended to enhance quality and identify improvements.
The document outlines quality management guidelines for the manufacture of active pharmaceutical ingredients according to ICH Q7. It discusses establishing an effective quality system involving quality assurance, quality control, and management participation. Responsibilities include approving documentation, releasing materials, auditing, handling deviations, and conducting product quality reviews. The quality unit is responsible for reviewing and approving processes, specifications, equipment, and changes that could impact quality.
Gmp (q7 ich guide) & Stem cells-based therapy product manufacturingM. Agung Sumantri
This document provides a summary of key points from the ICH Q7 guideline on good manufacturing practices for active pharmaceutical ingredients:
- It establishes quality management principles for ensuring APIs meet intended specifications, including defining organizational structures, procedures, processes, and responsibilities.
- Manufacturing operations of APIs and intermediates should be clearly defined and documented. Any deviations must be documented and investigated.
- An independent quality unit is responsible for approving or rejecting APIs, materials, equipment, processes, and review of production records, audits and product quality reviews.
- Personnel involved in manufacturing APIs must be qualified and trained. Hygiene practices and facilities must allow for clean and orderly manufacturing operations.
How to Perform a Successful Internal Quality AuditGreenlight Guru
You already know internal quality audits are required by both FDA 21 CFR Part 820 and ISO 13485.
You also probably already know they are a big hassle to conduct.
What you might not know is that they are one of the most powerful weapons at your disposal for preventing 483's and observations.
Why?
Because they are one of the most effective and efficient ways to make sure you and your team are always prepared if FDA or NB decided to show up unexpectedly.
So how do you “establish” the right procedures? How do you ensure your auditor is competent and properly qualified? And what do you do if you find non-conformances?
View this presentation by our guest Kyle Rose, President at Rook Quality Systems, where you will find the answers to all those questions and more.
Specifically, you will learn:
- How to conduct an effective internal quality audit based on process identification, sampling and questioning
- How to plan a internal quality audit and develop an audit schedule
- How to find and use competent and qualified auditors
- Why certain auditors shouldn’t audit certain areas
- How to properly report the findings of your internal quality audit
- How to concisely document non-conformances
- How to determine what needs corrective actions and how to follow up on them
This document discusses handling deviations from standard operating procedures in quality management systems. It defines a deviation as any departure from approved instructions or established standards. Deviations are classified as either planned or unplanned. Unplanned deviations require investigation to determine the root cause and implement corrective and preventive actions. The investigation process involves documenting the event, taking immediate action, analyzing the root cause, implementing corrective actions, and evaluating effectiveness. Guidelines such as ICH Q7 provide requirements for deviation handling, investigation, and corrective action to prevent future deviations.
Extensively used in pharmaceutical for product quality analysis. For trend analysis of product and steps of manufacturing it is widely used. By calculating cpk value any out of specification can be determined. It is more important tools to analyze from starting material to finished product
The document discusses various types of quality assurance (QA) audits, including internal and external audits. It notes that the most common types of audits in the food industry are for product manufacturing, plant sanitation/GMP, product quality, and HACCP. Special audits may also be conducted on areas like QC programs, temperature controls, or batching practices. QA documentation includes standard operating procedures (SOPs), a quality manual, and other documents describing manufacturing and quality processes. Sanitation standard operating procedures (SSOPs) provide step-by-step instructions for cleaning areas and equipment in a food plant.
SAI Global Webinar: BRC Food Safety Issue 8Switzerland09
In August 2018, the BRC Global Standard for Food Safety will move from issue 7 to issue 8. This is the slide deck from a live webinar on July 9th which shares insight into the changes.
This document discusses various post-approval requirements and processes for pharmaceutical drugs, including prior approval supplements, changes being effected in 30 days supplements, annual reports, labeling changes, recalls, FDA inspections, and ISO 31000 risk management standards. It provides details on submission requirements and timelines for different types of post-approval changes, as well as FDA enforcement actions like warning letters, seizures, and injunctions.
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.
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.
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.
This document provides an overview of process validation according to FDA guidance. It defines process validation as collecting data from process design through commercial production to establish that a process is capable of consistently delivering quality products. The guidance outlines a lifecycle approach with three stages: process design, process qualification, and continued process verification. Process design defines the commercial process based on development knowledge. Process qualification evaluates the design and determines if the process is reproducible. Continued process verification ensures the process remains controlled during routine production. Critical quality attributes and critical process parameters are identified, and control strategies are established.
SAI Global Webinar: Deep Dive - BRC Food Safety Issue 8Switzerland09
This document provides information about an upcoming webinar on the changes to the BRC Global Standard for Food Safety Issue 8. The webinar will cover the key changes to the requirements and audit protocol in Issue 8, including a focus on developing a product safety culture, expanding environmental monitoring requirements, and providing greater clarity for high risk production areas and pet food manufacturing. The webinar presenters will provide background on the changes, discuss their implications, and outline next steps.
Jyoti Kothari has over 24 years of experience in quality assurance roles in the pharmaceutical industry, including managing quality assurance as well as experience in validation, auditing, and ensuring compliance. She has a strong background in GMP requirements and regulatory submissions. Her experience includes roles managing quality assurance and serving as a compliance manager at various pharmaceutical companies.
Presentation Updating the Manufacturing Principles TGA Australia
The document discusses updates to the PIC/S Guide to GMP (PE009). It provides an overview of the processes used by the EMA, PIC/S, and TGA to adopt and implement GMP updates. It outlines some of the key changes between PE009-13 and the previous version, and discusses future revisions including changes expected in PE009-14 regarding premises and equipment, production, complaints and recalls. The speaker emphasizes that GMPs are updated regularly to address risks to patient health and ensure international equivalence, and that manufacturers should follow the TGA's transition plan to adopt the latest requirements.
Presentation: TGA manufacturing principles update - Adoption of PIC/S Guide t...TGA Australia
TGA is adopting updates to the PIC/S Guide to GMP including PE009-13 and future revisions such as PE009-14. Key points include:
- PE009-13 was adopted on January 1, 2018 with a 12 month transition period for industry to comply.
- Future revisions will address additional chapters and annexes to further clarify requirements.
- TGA plays an active role in updating PIC/S GMP guidance to ensure risks are addressed and GMP keeps pace with innovation.
- Adopting international standards supports TGA's mutual recognition agreements and provides assurance in international markets.
Quality measures are tools that help us measure or quantify healthcare processes, outcomes, patient perceptions, and organizational structure and/or systems that are associated with the ability to provide high-quality health care and/or that relate to one or more quality goals for health care.
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kol...rightmanforbloodline
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kolb, Ian Q. Whishaw, Verified Chapters 1 - 16, Complete Newest Versio
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kolb, Ian Q. Whishaw, Verified Chapters 1 - 16, Complete Newest Version
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kolb, Ian Q. Whishaw, Verified Chapters 1 - 16, Complete Newest Version
Does Over-Masturbation Contribute to Chronic Prostatitis.pptxwalterHu5
In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Kat...rightmanforbloodline
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech 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!
2. The Overview
• WHAT is an APR and WHY do we need it
• Scope, Glossary and Responsibilities
• The Requirements
Basic requirements
What must be in the APR, at a minimum
Additional Local Requirements (EU, CFR, ICH Q7
for APIs)
What may be included
Approval and Archiving
• Helpful Checklist to prepare the APR/PQR
3. Annual Product Review - WHAT
• APR for each commercial product
• APR should confirm the State of Control
Directive Statement:
An Annual Product Review must be conducted for each
commercial product. The purpose of this annual review is to verify the
consistency of the process, to assess trends, to determine the need for
changes in specification, production, manufacturing and/or control
procedures and to evaluate the need for revalidation.
Annual Product Reviews (APRs) are important for
communication between manufacturing, quality and regulatory Affairs,
to enable quality improvement processes. Content and management of
Annual Product Reviews must be established according to this directive.
4. Annual Product Review - WHY
• "Reviews" are a critical element of any Quality
Management System. Regular reviews of process
and quality system performance is necessary to
ensure product quality.
• All regulatory authorities require "reviews“ which
may be called
"Annual Product Review“ (US GMP term), or
"Product Quality Review“ (EU GMP term)
• Expectations regarding contents and objectives
are more or less the same.
5. 2. Scope
This scope applies to manufacturing
sites, Affiliates and subcontractors
6. 3. Glossary
Annual Product Review (APR)
• Periodic review of the product’s production documents,
release data, stability data, product complaints, etc. to
establish trends and determine any issues
• A report must be issued to Senior Site Management on an
annual basis
• Annual Product Reviews are applicable to commercial
products [such as API, intermediate for API, pharmaceutical
product (i.e. drug product) and medical devices].
7. 4. Responsibilities (1)
• Senior Site Quality Management at manufacturing site or
External Manufacturing Unit that releases the active
pharmaceutical ingredient (API), pharmaceutical product
(i.e. drug product) or medical device is responsible for
ensuring that an Annual Product Review and the report
for the Annual Product Review are completed and issued
• Where semi-finished product is processed in multiple
sites, all sites involved must participate in the Annual
Product Review process by providing information to the
site of release.
8. 4. Responsibilities (2)
• Individual departments, such as Industrial Technologies,
Purchasing, Engineering, Manufacturing, Information
Solutions, Quality and Compliance, Pharmacovigilance and
Regulatory Affairs are responsible for providing data and
participating in the Annual Product Review process
• Senior Site Quality Management or External Manufacturing
Unit (as applicable), Senior Site Production Management and
Senior Site Management must approve the Annual Product
Review Report
• The resulting report must be distributed at least to Senior Site
Management with critical deviations reported to the Global
Head of Quality and Compliance.
9. 4. Responsibilities (3)
New Statement in Version 3 (Feb. 2008):
• Where the marketing authorisation holder is not the
manufacturer, their respective responsibilities is defined in a
quality agreement in place between the various parties
• The Qualified Person responsible for the final batch
certification must ensure that the annual product review is
performed on a yearly basis in a timely manner and is
accurate
• In case of anomaly/deviation found, the information of the
marketing authorization holder is performed in accordance
with the requirements of the current directive "Quality Alert
Management.
10. 5. Requirements (1)
• Each site must have written procedures, which must be
followed when conducting Annual Product Reviews.
• The Annual Product Review must cover a one-year rolling
period, but does not have to coincide with a calendar year
• The review should normally be completed within sixty (60)
calendar days of the period close and must in all cases be
completed within ninety (90) calendar days of the period
close
• If the production is less than 3 batches per year, an annual
product review must still be conducted and this review can
include a review performed on the 2 or 3 preceding
production years
11. 5. Requirements (2)
• The number of batches to be considered is the number of batches
manufactured during the agreed annual period. The Annual Product
Review must include all batches of product whether they were
accepted or rejected or destroyed during manufacture
• The Annual Product Review report must address the assessment of
data, documents and electronic records reviewed
• For active pharmaceutical ingredients, the Annual Product Review
includes the manufacturing critical steps
• Annual Product Reviews are to take into account previous reviews.
12. 5. Requirements (3)
• An Annual Product Review must be prepared for each
water quality grade produced at each site
• New Statements in Version 3 (Feb. 2008):
• If one quality of water is only used for one product ,
the data concerning this water can be included in the
APR of the corresponding APIs
• For critical utilities it is recommending either to
perform a separate APR or to include a specific
chapter in the APR of the corresponding APR
13. Review must include, at a
minimum (1)
• Review of any recommendations and actions taken from
prior report
• "Basic statistics"
Number of batches manufactured, including partially
completed batches and corresponding yields
Number and percentage of batches rejected and
related reasons
Number and percentage of batches reworked or
reprocessed and related reasons
Critical in-process controls, finished product results
and critical API test results
14. Review must include, at a
minimum (2)
• Review of "deviations from the validated state“
A review of all batches that failed to meet established
specification(s) and their investigation
Significant/critical deviations, Out of Specification Results and
related failure investigations (review of adequacy and
effectiveness of corrective and preventative actions taken)
A review of the adequacy of all corrective actions
Product quality complaints
Product Recalls
15. Review must include, at a
minimum (3)
• Review of "deviations from the validated state“
Product Recalls
Critical regulatory issues
Quality related issues for returned, and/or salvaged
goods
Changes effected (change control) and variations
during the period (e.g. process, suppliers, equipment)
Changes of product specifications or methods (e.g.
analytical changes, and results)
Process Validation Status
16. Review must include, at a
minimum (4)
• Trend Analysis
Trend analysis on key in-process and release testing with graphic
representation and basic statistics recommended
A review of the results of the stability monitoring program and
trend analysis on stability data
• Observations/Recommendations
From any official inspectorate which directly concern and relate
to the product under review (i.e. not observations/
recommendations which relate to general quality system issues)
New recommendations from this review
17. Further Requirements
• Additional items must be added to the APR/PQR in
line with local regulatory requirements (e.g. EU GMP
Chapter 1). All of these topics to be covered by the
review must be stated in a site procedure.
• The results of the APR must be evaluated and an
assessment made whether corrective or preventive
action (CAPA) or any re-validation is necessary.
• A conclusion statement must be written to assess if
the product consistently meets its quality attributes,
and if not, what actions need to be taken. Rationale
for such CAPAs must be documented.
18. The EU Requirements for PQR (1)
• EU Guidelines to Good Manufacturing Practice ;
Medicinal Products for Human and Veterinary
Use ; Part I ; Chapter 1 Quality Management
(issued on 25 October 2005)
Product Quality Review
1.5 Regular periodic or rolling quality reviews of all licensed medicinal products,
including export only products, should be conducted with the objective of verifying
consistency of the existing process, the suitability of current specifications for both
starting materials and finished product to highlight any trends and to identify
product and process improvements. Such reviews should normally be conducted
and documented annually, taking into account previous reviews, and should
include at least:
19. The EU Requirements for PQR (2)
• A review of starting materials and packaging
materials used for the product, especially those
from new sources
• A review of critical in- process controls and
finished product results
• A review of all batches that failed to meet
established specification(s) and their
investigation.
20. The EU Requirements for PQR (3)
• A review of all significant deviations or non
conformances, their related investigations, and the
effectiveness of resultant corrective and
preventative actions taken
• A review of all changes carried out to the
processes or analytical methods
• A review of Marketing Authorisation variations
submitted/granted/refused, including those for
third country (export only) dossiers.
21. The EU Requirements for PQR (4)
• A review of the results of the stability
monitoring programme and any adverse
trends
• A review of all quality- related returns,
complaints and recalls and the investigations
performed at the time
• A review of adequacy of any other previous
product process or equipment corrective
actions.
22. The EU Requirements for PQR (5)
• For new marketing authorisations and
variations to marketing authorisations, a
review of post-marketing commitments
• The qualification status of relevant
equipment and utilities, e.g. HVAC, water,
compressed gases, etc
• A review of Technical/Quality Agreements to
ensure that they are up to date.
23. The EU Requirements for PQR (6)
Subcontractors and Technical Agreements
The manufacturer and marketing authorisation holder, where different, should
evaluate the results of this review and an assessment should be made
whether corrective and preventative action or any revalidation should be
undertaken. Reasons for such corrective actions should be documented.
Agreed corrective and preventative actions should be completed in a timely
and effective manner. There should be management procedures verified
during self-inspection. Quality review may be grouped by product type, e.g.
solid dosage forms, liquid dosage forms, sterile products, etc. where
scientifically justified.
Where the marketing authorisation holder is not the manufacturer, there
should be a technical agreement in place between various parties that defines
their respective responsibilities in producing the quality review. The Qualified
Person responsible for the final batch certification together with the marketing
authorisation holder should ensure that the quality review is performed in a
timely manner and is accurate.
24. The US Requirements:
21 CFR 211.180 (e)
• … data … used for evaluating, at least annually,
the quality standards of each drug product to
determine the need for changes in drug product
specifications or manufacturing or control
procedures
A review of a representative number of batches,
whether approved or rejected, and, where applicable,
records associated with the batch
A review of complaints, recalls, returned or salvaged
drug products, and investigations conducted under
Sec. 211.192 for each drug product.
25. The Requirements for APIs in ICH Q7
2.5 Product Quality Review
2.50
Regular quality reviews of APIs should be conducted with the objective of verifying
the consistency of the process. Such reviews should normally be conducted and
documented annually and should include at least:
•A review of critical in-process control and critical API test results;
•A review of all batches that failed to meet established specification(s);
•A review of all critical deviations or non-conformances and related investigations;
•A review of any changes carried out to the processes or analytical methods;
•A review of results of the stability monitoring program;
•A review of all quality-related returns, complaints and recalls; and
•A review of adequacy of corrective actions
2.51
The results of this review should be evaluated and an assessment made of whether
corrective actions or any revalidation should be undertaken. Reasons for such
corrective action should be documented. Agreed corrective actions should be
completed in a timely and effective manner.
26. What may be included in the
APR
• Follow-up actions may be included but are not limited
to:
Product process improvement
Formulation improvement
Analytical method improvements
In-process or final product specification
review
Revalidation
Product recall or withdrawal
New packaging
27. Approval and Archiving
• Annual Product Reviews will be reviewed,
assessed, and approved by Senior Site Quality
Management, Site Production Management and
Senior Site Management
• The approved documents must be archived for a
minimum of 11 years and made available (upon
request) during internal or external audits by
Regulatory Authorities.
28. Helpful Checklist to prepare the PQR
(1)
• Are there any outstanding validation
commitments or corrective and preventive
action plans from last PQR ?
• Are the processes in a validated state or is
additional validation work needed ?
• Is the qualification status (IQ/OQ/PQ)
acceptable ?
29. Helpful Checklist to prepare the PQR
(2)
• Are all critical aspects performing satisfactorily or are
corrective/preventive action plans required ?
• Are there any significant findings concerning
specifications or test methods ?
• Are there any significant findings concerning data
trending of the manufacturing process, starting
materials, or packaging materials ?
• Are there any significant findings concerning deviations
and non- conformances ?
30. Helpful Checklist to prepare the PQR
(3)
• Are there any significant findings concerning
changes performed ?
• Are there any significant findings concerning out
of specification results ?
• Are there any significant findings concerning
rejected batches, quality-related returns,
customer complaints, or recalls ?
31. Helpful Checklist to prepare the PQR
(4)
• Are there any significant findings concerning
the stability monitoring program ?
• Are there any significant findings concerning
retain sample examination ?
• Are all post- marketing commitments to
Authorities met ?
• Are all required Technical Agreements in place
and up-to-date ?
32. PQR Principles should be
followed
• Focus on evaluation and assessment of data and
information
Create a meaningful list of facts and data
• Reviews should focus on mid- and long-term
trends (e.g. intra- and inter-batch) because these
trends are not obvious from single batch data
Therefore, make a connection to the previous report
• One element of a meaningful review is the
verification of selected original records (e.g. batch
record, test records)
33. The PQR should confirm the State of
Control
• 'Validated status' based on assessment of process
performance (critical / relevant process information,
trends)
• Closure of any deviation from the validated state,
especially changes, batch failures / OOS / deviations,
or complaints / recalls
• Confirmation that the product is stable
• Confirmation that specifications and acceptance
criteria are still suitable to assure product quality.