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.
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.
Review of Quality Control Record and Analytical Data by Dr. A. AmsavelDr. Amsavel A
Review of Quality Control Record and Analytical Data
Objective and Requirement for Analytical data review
Role of Analyst and reviewer,
Procedure and checklist for review of records/data
Review of traceable /associated documents
Review of calibration, Reference standard record, sampling reports,
Review of Audit trail
Role of Analyst & Reviewer
Review of chromatograms& audit trail,
Data Integrity & Good Record Practice
FDA Citations
Presentation PIC/S Guide to GMP PE009-13 Annex 15TGA Australia
The document summarizes key changes made to Annex 15 of the PIC/S Guide to GMP regarding qualification and validation. It introduces concepts such as critical process parameters and critical quality attributes from ICH Q8 and Q11. It provides more flexibility in qualification approaches and emphasizes the need for risk assessments. It also outlines new guidance for various validation approaches including continuous process verification, ongoing process verification, and transportation validation.
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.
This document discusses process validation for liquid oral dosage forms. It defines process validation and explains that it ensures consistent production of products meeting quality standards. The objectives are to assure product quality and reduce batch variation. Types of liquid orals include solutions, suspensions, and emulsions. Critical process parameters for equipment, processing, and acceptance criteria are identified. The validation operations described include testing of raw materials and monitoring of outputs like appearance, pH, and content uniformity. A validation report is prepared and changes may require revalidation.
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 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.
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.
Review of Quality Control Record and Analytical Data by Dr. A. AmsavelDr. Amsavel A
Review of Quality Control Record and Analytical Data
Objective and Requirement for Analytical data review
Role of Analyst and reviewer,
Procedure and checklist for review of records/data
Review of traceable /associated documents
Review of calibration, Reference standard record, sampling reports,
Review of Audit trail
Role of Analyst & Reviewer
Review of chromatograms& audit trail,
Data Integrity & Good Record Practice
FDA Citations
Presentation PIC/S Guide to GMP PE009-13 Annex 15TGA Australia
The document summarizes key changes made to Annex 15 of the PIC/S Guide to GMP regarding qualification and validation. It introduces concepts such as critical process parameters and critical quality attributes from ICH Q8 and Q11. It provides more flexibility in qualification approaches and emphasizes the need for risk assessments. It also outlines new guidance for various validation approaches including continuous process verification, ongoing process verification, and transportation validation.
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.
This document discusses process validation for liquid oral dosage forms. It defines process validation and explains that it ensures consistent production of products meeting quality standards. The objectives are to assure product quality and reduce batch variation. Types of liquid orals include solutions, suspensions, and emulsions. Critical process parameters for equipment, processing, and acceptance criteria are identified. The validation operations described include testing of raw materials and monitoring of outputs like appearance, pH, and content uniformity. A validation report is prepared and changes may require revalidation.
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 defines cleaning validation and discusses its importance in ensuring product safety and purity. It outlines the key phases of cleaning validation: planning, execution, analytical testing, and reporting. The planning phase involves forming a validation team with representatives from relevant departments. The team is responsible for developing cleaning procedures, methods, and acceptance criteria. Validation employs techniques like swab and rinse sampling to test equipment for residue following cleaning. Proper documentation and revalidation when processes change are also important aspects of cleaning validation discussed.
This document discusses analytical method validation. It provides definitions and guidelines for validating analytical methods from regulatory agencies. Key aspects of method validation discussed include accuracy, precision, specificity, range, linearity, limits of detection and quantification. Validation parameters are described for different types of analytical tests including identification, quantitative impurity tests and assays. Guidelines are provided for qualifying analytical instrumentation and categorizing instruments based on complexity.
This document discusses blend uniformity analysis (BUA), which tests the adequacy of mixing active pharmaceutical ingredients with other drug product components. BUA is recommended for dosage forms requiring content uniformity testing. Under good manufacturing practices, each commercial batch must be tested to validate uniform mixing. Sample size for BUA is typically 6-10 points, with samples less than 3 times an individual dose. Acceptance criteria for BUA assays is 90-110% of the mean with an RSD of no more than 5%. Stratified sampling targets locations with higher failure risks. The Product Quality Research Institute recommends additionally testing stratified dosage unit samples throughout production.
This presentation correlates the requirements of Annex 11 guidelines to other official regulations and guidance documents.
The correlation is organized in a tabular format.
In the row lists the contents of Annex 11 together with the paragraph numbers.
Rest of the rows correlate the section numbers of
Annex 11 Versions 1993
US FDA 21 CFR Part 211
US FDA Part 820 and
US FDA 21 CFR Part 11
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.
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.
Equipment qualification of medical deviceNahri Musyrif
The document defines key terms related to qualification and validation such as qualification, validation, commissioning, and calibration. It discusses classifying systems based on their impact on product quality and determining appropriate qualification approaches. Risk assessments are an important part of qualification and should be conducted according to GMP guidelines. Design, installation, operational, and performance qualifications are described as the key qualification steps. The importance of maintaining qualification status over the lifecycle is also covered.
This document outlines the quality risk assessment process at Hester Bioscience Limited. It discusses risk assessment for products, processes, equipment, facilities and more. Key points include:
- Quality risk assessment is a systematic process to identify, analyze, evaluate and control risks that could affect quality. It is applied across the product lifecycle.
- Risks are identified based on factors like deviations, complaints, audits and changes. They are analyzed using tools like FMEA to determine severity, likelihood and current controls.
- Identified risks are evaluated and assigned a risk level of minor, major or critical. Control measures are considered and implemented to reduce risks to acceptable levels.
- Various departments and functions are
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.
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.
ICH Q6A Specifications by Chandra MohanChandra Mohan
The document provides guidelines on specifications for new drug substances and products. It defines specifications and outlines universal tests that should be included for both drug substances and products, such as description, identification, assay, and impurities. It also describes specific tests that may be included depending on the dosage form, such as dissolution, disintegration, hardness/friability for solid oral dosage forms. The guidelines provide information on justifying acceptance criteria and setting specifications based on development data and stability studies.
Pharmaceutical principles of QA, GMP and QCDominic Parry
This document discusses quality management systems in the pharmaceutical industry. It covers quality assurance, good manufacturing practices, and quality control. Quality assurance aims to ensure medicines are of the required quality for their intended use. Good manufacturing practices ensure consistent production and quality control of medicines. Quality control involves sampling, testing, and releasing products once their quality is verified. Together, quality assurance, good manufacturing practices, and quality control work to deliver safe and effective medicines to patients.
FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality (this has long been recognized in other industries).In order for quality to increase, it must be built into the product. To do this requires understanding how formulation and manufacturing process variables influence product quality.Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.
This presentation - Part V in the series- deals with the concepts of Control strategy and PAT. This presentation was compiled from material freely available from FDA , ICH , EMEA and other free resources on the world wide web.
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 discusses quality management systems and the six system inspection model used by the FDA to ensure compliance with cGMP regulations. It describes each of the six systems - quality system, production system, facilities and equipment system, laboratory control system, materials system, and packaging and labeling system. For each system, it provides an overview and lists the relevant cGMP subparts that govern inspections of that system. The goal is to help pharmaceutical manufacturers implement quality systems to meet FDA requirements.
a short briefs for retraining of ISO9001:2008 Internal auditors
بعد از سالها یک بار دیگر این دوره را اجرا کردم البته با یک کم تغییرات بنیادی در انتقال مفاهیم بنیادی که در اسلایدها قابل بررسی است البته نسخه 2015 آن هم در راه است.
The document defines cleaning validation and discusses its importance in ensuring product safety and purity. It outlines the key phases of cleaning validation: planning, execution, analytical testing, and reporting. The planning phase involves forming a validation team with representatives from relevant departments. The team is responsible for developing cleaning procedures, methods, and acceptance criteria. Validation employs techniques like swab and rinse sampling to test equipment for residue following cleaning. Proper documentation and revalidation when processes change are also important aspects of cleaning validation discussed.
This document discusses analytical method validation. It provides definitions and guidelines for validating analytical methods from regulatory agencies. Key aspects of method validation discussed include accuracy, precision, specificity, range, linearity, limits of detection and quantification. Validation parameters are described for different types of analytical tests including identification, quantitative impurity tests and assays. Guidelines are provided for qualifying analytical instrumentation and categorizing instruments based on complexity.
This document discusses blend uniformity analysis (BUA), which tests the adequacy of mixing active pharmaceutical ingredients with other drug product components. BUA is recommended for dosage forms requiring content uniformity testing. Under good manufacturing practices, each commercial batch must be tested to validate uniform mixing. Sample size for BUA is typically 6-10 points, with samples less than 3 times an individual dose. Acceptance criteria for BUA assays is 90-110% of the mean with an RSD of no more than 5%. Stratified sampling targets locations with higher failure risks. The Product Quality Research Institute recommends additionally testing stratified dosage unit samples throughout production.
This presentation correlates the requirements of Annex 11 guidelines to other official regulations and guidance documents.
The correlation is organized in a tabular format.
In the row lists the contents of Annex 11 together with the paragraph numbers.
Rest of the rows correlate the section numbers of
Annex 11 Versions 1993
US FDA 21 CFR Part 211
US FDA Part 820 and
US FDA 21 CFR Part 11
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.
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.
Equipment qualification of medical deviceNahri Musyrif
The document defines key terms related to qualification and validation such as qualification, validation, commissioning, and calibration. It discusses classifying systems based on their impact on product quality and determining appropriate qualification approaches. Risk assessments are an important part of qualification and should be conducted according to GMP guidelines. Design, installation, operational, and performance qualifications are described as the key qualification steps. The importance of maintaining qualification status over the lifecycle is also covered.
This document outlines the quality risk assessment process at Hester Bioscience Limited. It discusses risk assessment for products, processes, equipment, facilities and more. Key points include:
- Quality risk assessment is a systematic process to identify, analyze, evaluate and control risks that could affect quality. It is applied across the product lifecycle.
- Risks are identified based on factors like deviations, complaints, audits and changes. They are analyzed using tools like FMEA to determine severity, likelihood and current controls.
- Identified risks are evaluated and assigned a risk level of minor, major or critical. Control measures are considered and implemented to reduce risks to acceptable levels.
- Various departments and functions are
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.
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.
ICH Q6A Specifications by Chandra MohanChandra Mohan
The document provides guidelines on specifications for new drug substances and products. It defines specifications and outlines universal tests that should be included for both drug substances and products, such as description, identification, assay, and impurities. It also describes specific tests that may be included depending on the dosage form, such as dissolution, disintegration, hardness/friability for solid oral dosage forms. The guidelines provide information on justifying acceptance criteria and setting specifications based on development data and stability studies.
Pharmaceutical principles of QA, GMP and QCDominic Parry
This document discusses quality management systems in the pharmaceutical industry. It covers quality assurance, good manufacturing practices, and quality control. Quality assurance aims to ensure medicines are of the required quality for their intended use. Good manufacturing practices ensure consistent production and quality control of medicines. Quality control involves sampling, testing, and releasing products once their quality is verified. Together, quality assurance, good manufacturing practices, and quality control work to deliver safe and effective medicines to patients.
FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality (this has long been recognized in other industries).In order for quality to increase, it must be built into the product. To do this requires understanding how formulation and manufacturing process variables influence product quality.Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.
This presentation - Part V in the series- deals with the concepts of Control strategy and PAT. This presentation was compiled from material freely available from FDA , ICH , EMEA and other free resources on the world wide web.
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 discusses quality management systems and the six system inspection model used by the FDA to ensure compliance with cGMP regulations. It describes each of the six systems - quality system, production system, facilities and equipment system, laboratory control system, materials system, and packaging and labeling system. For each system, it provides an overview and lists the relevant cGMP subparts that govern inspections of that system. The goal is to help pharmaceutical manufacturers implement quality systems to meet FDA requirements.
a short briefs for retraining of ISO9001:2008 Internal auditors
بعد از سالها یک بار دیگر این دوره را اجرا کردم البته با یک کم تغییرات بنیادی در انتقال مفاهیم بنیادی که در اسلایدها قابل بررسی است البته نسخه 2015 آن هم در راه است.
مدیریت کیفیت چیست؟
تاریخچه مدیریت کیفیت چیست؟
تکنیکهای اصلی در مدیریت کیفیت کدامند؟
کیفیت داده به چه معناست؟
ابعاد اصلی در کیفیت داده کدامند؟
مطالعه موردی .....
88. Statistical Process Control (SPC)
ایننسبتهابهشماکمکمیکندکه:
پیشبینیاینکهخرابیهادرسمتمشخصهبیشتراتفاقمیافتدیاسمت
مشخصهپایین.
تصمیمگیریدرموردمیانگینفرایند
تصمیمگیریدرمورداینکهآیاگستردگیتلورانسرادرنظربگیریم.
تصمیمگیریدرموردسطحبازرسیموردنیاز.
89.
90. Cisplatin injection finished Dosage
form Analytical Data
of pH and Assay values are
tabulated in below to explain the
process capability index of
pharmaceutical drug products.
97. • Individuals (I) chart
• Moving Range (MR) chart
s.narimani@farabipharma.ir 97
Capability Analysis, I-MR Control Chart
98. • measure pH for 25 consecutive batches
• Choose Stat > Control Charts > Variables Charts for
Individuals > I-MR and select pH as the Variable
s.narimani@farabipharma.ir 98
Capability Analysis, I-MR Control Chart
99. • so click I-MR Options, and then choose Tests
• Choose "Perform all tests for special causes," and then click OK in
each dialog box
• When an observation fails a test, Minitab reports it in the Session
window and marks it on the I chart. A failed point indicates a
nonrandom pattern in the data that should be investigated.
s.narimani@farabipharma.ir 99
Capability Analysis, I-MR Control Chart
101. Steps in Minitab to run a process
capability analysis:
1-Click Stat → Basic Statistics →
Normality Test.
2-A new window named “Normality
Test” pops up.
3-Select “HtBk” as the variable.
Capability Analysis, Normal OR Non-Normal?
s.narimani@farabipharma.ir 101
102. 4-Click “OK.”
5-The histogram and the normality
test results appear in the new
window.
s.narimani@farabipharma.ir 102
Capability Analysis, Normal OR Non-Normal?
103. 4-Click “OK.”
5-The histogram and the normality
test results appear in the new
window.
• In this example, the p-value is
0.275, greater than the alpha level
(0.05). We conclude that the data
are normally distributed.
s.narimani@farabipharma.ir 103
Capability Analysis, Normal OR Non-Normal?
104. 6-Click Stat → Quality Tools →
Capability Analysis→ Normal.
7-A new window named
“Capability Analysis(Normal
Distribution)” pops up.
8-Select “HtBk” as the single
column and enter “1” as the
subgroup size.
9-Enter “6” as the “Lower spec”
and “7” as the “Upper spec”
s.narimani@farabipharma.ir 104
Capability Analysis, Normal
105. 10-Click “Options” button and
another new window named
“Capability Analysis(Normal
Distribution) – Options” pops
up.
11-Enter “6.5” as the target and
click “OK.”
s.narimani@farabipharma.ir 105
Capability Analysis, Normal
106. 12-Click “OK” in the “Capability
Analysis(Normal Distribution)”
window.
13-The capability analysis results
appear in the new window.
s.narimani@farabipharma.ir 106
Capability Analysis, Normal
-مقدار که شود می توصیهCp/Cpkبرابر1/33باشد بیشتر یا.