The document discusses validation procedures for manufacturing systems and equipment. It covers the different stages of qualification including design qualification, installation qualification, operational qualification, and performance qualification. Specific topics covered include qualification of HVAC and water systems, cleaning validation, analytical method validation, computerized system validation, and qualification of equipment. The document provides guidance on validating "critical systems and equipment" to ensure consistent product quality.
This document provides an overview of validation requirements for computerized systems used in manufacturing processes. It discusses validating both hardware and software, including system specifications, functional specifications, security, backups, and revalidation. The key aspects to consider include location, maintenance, inputs, outputs, limits, documentation, consistency, and functionality under worst-case conditions.
The document discusses concepts and terminology related to qualification and validation. It defines key terms like qualification, validation, validation master plan, user required specification, functional specification, design specification, factory acceptance test, site acceptance test, design qualification, installation qualification, operational qualification, and process/performance qualification. It also describes the different types of validation including prospective, concurrent, and retrospective validation. The overall purpose is to establish performance adequacy and ensure that facilities, systems, equipment, and processes are properly installed and working as intended.
1) The Validation Master Plan (VMP) is a comprehensive document describing the validation requirements and plan for a pharmaceutical production facility. It was prepared by Vishal H. Parikh for his professor Ms. Krupa Thula.
2) The VMP includes details on qualification protocols, personnel responsibilities, schedules, documentation requirements, and change control procedures to ensure the facility and processes are appropriately validated.
3) The VMP development process involves identifying regulatory standards and developing protocols for installation, operational, and performance qualification to test facility and equipment operations. The VMP then guides ongoing validation activities and system changes.
The document discusses principles and approaches to cleaning validation for pharmaceutical manufacturing. It covers topics such as cleaning validation protocols and reports, personnel and equipment, use of detergents, microbiology, sampling, analytical methods, acceptable limits, and bracketing of products for validation. The objectives of cleaning validation are to demonstrate that cleaning procedures adequately remove product, detergent, and microbial residues to prevent contamination and cross-contamination. Written standard operating procedures and documentation of validation studies are required.
The document discusses analytical method validation for good manufacturing practices. It covers validation of pharmacopoeial and non-pharmacopoeial methods, and characteristics that should be considered during validation including accuracy, precision, robustness, specificity, linearity, range, detection limit and quantitation limit. The objectives are to validate analytical methods to demonstrate suitability for their intended purpose and ensure results are reliable, accurate and reproducible.
The document discusses developing a validation master plan (VMP) for a new pharmaceutical facility. Key points:
- A VMP comprehensively describes validation requirements and plans for meeting them. It covers production, storage, utilities, and staff areas.
- The VMP sets goals and limits for validation projects. It defines the scope and systems included.
- Developing the VMP involves determining standards, qualifications for design, installation, operation, and performance, documentation requirements, and change control procedures.
- User requirement specifications (URS) are critical documents that validation is dependent on. Developing clear, testable URS in multiple levels is important, especially for software.
The document discusses concepts and terminology related to qualification and validation of equipment and systems. It defines qualification as proving that premises, systems and equipment are properly installed and work correctly. Validation is defined as proving that processes, procedures or methods consistently lead to expected results. The document provides definitions and descriptions of key terms in validation including validation master plan, user requirement specification, functional specification, design specification, factory acceptance testing, site acceptance testing, design qualification, installation qualification, operational qualification, process/performance qualification, protocols, reports, and types of validation.
This document provides an overview of validation requirements for computerized systems used in manufacturing processes. It discusses validating both hardware and software, including system specifications, functional specifications, security, backups, and revalidation. The key aspects to consider include location, maintenance, inputs, outputs, limits, documentation, consistency, and functionality under worst-case conditions.
The document discusses concepts and terminology related to qualification and validation. It defines key terms like qualification, validation, validation master plan, user required specification, functional specification, design specification, factory acceptance test, site acceptance test, design qualification, installation qualification, operational qualification, and process/performance qualification. It also describes the different types of validation including prospective, concurrent, and retrospective validation. The overall purpose is to establish performance adequacy and ensure that facilities, systems, equipment, and processes are properly installed and working as intended.
1) The Validation Master Plan (VMP) is a comprehensive document describing the validation requirements and plan for a pharmaceutical production facility. It was prepared by Vishal H. Parikh for his professor Ms. Krupa Thula.
2) The VMP includes details on qualification protocols, personnel responsibilities, schedules, documentation requirements, and change control procedures to ensure the facility and processes are appropriately validated.
3) The VMP development process involves identifying regulatory standards and developing protocols for installation, operational, and performance qualification to test facility and equipment operations. The VMP then guides ongoing validation activities and system changes.
The document discusses principles and approaches to cleaning validation for pharmaceutical manufacturing. It covers topics such as cleaning validation protocols and reports, personnel and equipment, use of detergents, microbiology, sampling, analytical methods, acceptable limits, and bracketing of products for validation. The objectives of cleaning validation are to demonstrate that cleaning procedures adequately remove product, detergent, and microbial residues to prevent contamination and cross-contamination. Written standard operating procedures and documentation of validation studies are required.
The document discusses analytical method validation for good manufacturing practices. It covers validation of pharmacopoeial and non-pharmacopoeial methods, and characteristics that should be considered during validation including accuracy, precision, robustness, specificity, linearity, range, detection limit and quantitation limit. The objectives are to validate analytical methods to demonstrate suitability for their intended purpose and ensure results are reliable, accurate and reproducible.
The document discusses developing a validation master plan (VMP) for a new pharmaceutical facility. Key points:
- A VMP comprehensively describes validation requirements and plans for meeting them. It covers production, storage, utilities, and staff areas.
- The VMP sets goals and limits for validation projects. It defines the scope and systems included.
- Developing the VMP involves determining standards, qualifications for design, installation, operation, and performance, documentation requirements, and change control procedures.
- User requirement specifications (URS) are critical documents that validation is dependent on. Developing clear, testable URS in multiple levels is important, especially for software.
The document discusses concepts and terminology related to qualification and validation of equipment and systems. It defines qualification as proving that premises, systems and equipment are properly installed and work correctly. Validation is defined as proving that processes, procedures or methods consistently lead to expected results. The document provides definitions and descriptions of key terms in validation including validation master plan, user requirement specification, functional specification, design specification, factory acceptance testing, site acceptance testing, design qualification, installation qualification, operational qualification, process/performance qualification, protocols, reports, and types of validation.
Validation is required by the FDA to demonstrate that pharmaceutical manufacturing processes and equipment consistently produce quality products meeting specifications. It involves establishing documented evidence through qualification protocols that address installation, operation, and performance of processes and systems. The goals of validation are to prove quality, functionality, and reproducibility and provide high assurance that specific processes and equipment reliably produce the intended results. Pharmaceutical companies must conduct validation according to FDA guidelines tailored to their unique systems and operations.
The document provides an overview of validation requirements in the pharmaceutical industry. It defines validation and discusses where the concept came from and why it is important. Validation helps ensure quality, reduces costs, and is a regulatory requirement. The document outlines various qualification stages including design qualification, installation qualification, operational qualification, and performance qualification. It provides details on what each stage involves and key parameters to test at each stage to ensure processes and equipment are functioning as intended.
The document discusses approaches to equipment qualification for pharmaceutical manufacturing using a lifecycle approach. It outlines key points including that equipment qualification should not be a one-time event but rather consider design, demonstration, and ongoing monitoring stages. It compares traditional IQ/OQ/PQ approaches to the ASTM E2500 standard and recommends following a consistent documentation hierarchy and using model document outlines for validation projects.
The document discusses risk-based approaches in GMP (Good Manufacturing Practices) project life cycles. It describes how to identify GMP projects, the benefits of a risk-based approach, and the typical structure and implementation of a GMP project life cycle. The life cycle includes phases for project origination, initiation, planning and design, execution and control, and close-out. It provides examples of tools and documents used in each phase, as well as who is responsible for key tasks and when they should be performed to successfully implement a risk-based GMP project life cycle. An interactive exercise is proposed to help apply the concepts.
This document discusses considerations for equipment qualification when purchasing, designing, or qualifying storage units. It provides definitions of key terms related to validation and equipment qualification. The document outlines regulatory requirements for validation documentation. It discusses key validation documents including validation master plans, protocols, reports, and change control systems. Challenges in validation like inadequate specifications and planning are covered. The importance of early involvement of validation personnel and good communication for validation success is emphasized.
The Validation Master Plan (VMP) describes all validation requirements for the production facility. It covers validation aspects for all production areas, storage, utilities, and staff facilities. The VMP ensures processes will consistently produce products that meet specifications. It describes the principles of validation and organization of qualification activities and equipment.
This document provides an overview of equipment qualification terminology and processes. It discusses conducting a risk assessment to determine validation requirements and maintaining qualified equipment. The key points covered include defining user requirements, performing installation qualification to verify proper installation, and operational qualification to confirm the equipment operates as intended. Maintaining qualification involves ongoing change control and periodic review.
Validation sampling should exceed routine QA sampling based on the impact and risk analysis of the change. The protocol should specify the sampling, such as number of samples, locations, and statistical analysis, based on the risk.
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 provides a qualification protocol for bag sealing equipment. It outlines responsibilities for authoring, executing, reviewing, and approving qualification tests. The protocol scope is to establish evidence that the bag sealer is properly installed and operating according to requirements. It describes the bag sealer, lists test plans to verify installation and operation, and defines acceptance criteria. Responsibilities for personnel involved in authoring, executing, reviewing and approving the qualification tests are also defined.
In this slide contains Introduction, overview and details of FACTORY ACCEPTANCE TEST
Presented by: P.NARESH (Department of pharmaceutical analysis).RIPER, anantapur
Best Practices to Implement an Effective Change Control Program Company WideMimi V Syahputri
Understand the process/system.
Define how would you like to set your change control system based on process/system (one for all/grouping).
Categorize it (risk based approach).
Establish robust procedure with guidance.
Establish user friendly and informative form.
Establish robust data base.
Set up an effective training program.
Establish monitoring for continuous improvement.
Process validation fof Pharmaceutical dosage forms (formulation)MD NOUSHAD JAVED
This document discusses process validation for solid dosage forms such as tablets. It defines process validation as establishing documented evidence through a systematic approach to give a high degree of assurance that a specific process consistently produces quality products meeting predetermined specifications. The document outlines key steps in validation including identifying, measuring, evaluating and documenting critical process parameters to ensure quality. It discusses validation of facilities, equipment, raw materials, analytical methods and monitoring of in-process and finished product tests to control critical process variables. The document provides guidelines for validating common unit operations in solid dosage manufacturing such as mixing, granulation, drying, milling, compression, coating and encapsulation.
The document discusses current regulatory trends in the pharmaceutical industry. It mentions guidance from the FDA and ICH on quality systems and compliance. Major reasons for recalls in recent years involved GMP deviations, temperature abuse, and products marketed without approval. The document also discusses enforcement of compliance by the FDA through warning letters and inspections. It provides an overview of stages in instrument qualification and differences in perspectives between regulators and customers. Recent changes in GAMP and USP guidance are summarized as well.
Validation is the process of establishing documented evidence that a process consistently produces a product meeting its predetermined specifications and quality attributes. There are different types of validation including prospective, concurrent, and retrospective validation as well as revalidation. Process validation involves qualification steps including design qualification, installation qualification, operational qualification, and performance qualification outlined in a validation master plan. Method validation demonstrates that an analytical method is suitable for its intended purpose by testing method characteristics such as accuracy, precision, specificity, detection limit, quantitation limit, linearity, and range.
The document discusses several auxiliary facility programs that are important components of a GMP quality system, including pest control, cleaning programs, drawing control, engineering change control, spare parts management, lubricant control, and qualification of maintenance technicians and outside contractors. It emphasizes that written procedures and documentation are required for these programs to ensure facilities and equipment are properly maintained and calibrated.
The document discusses requalification and calibration processes in pharmaceutical manufacturing. It defines requalification as revalidating equipment, processes, or facilities after changes to ensure quality is not impacted. Requalification is required after significant changes like batch size changes or new equipment. Calibration verifies instrument accuracy and preventative maintenance keeps instruments qualified. A calibration program includes procedures, frequencies, tolerances and documentation of activities. Change control reviews any changes that could affect validation status and ensures continued validation. The document outlines the qualification and validation of materials, manufacturing equipment, analytical instruments and laboratory equipment used in pharmaceutical production.
This document provides information on various qualification documents used in pharmaceutical industries, including:
- User Requirement Specification (URS) which documents the end user requirements and functionality.
- Design Qualification (DQ) which verifies that the design will meet the requirements in the URS.
- Installation Qualification (IQ) which verifies proper installation.
- Operational Qualification (OQ) which tests the operation of the equipment.
- Performance Qualification (PQ) which verifies the equipment can perform as intended based on approved processes and specifications.
Guidance and requirements for each qualification type are defined. Supporting documents required for each are also listed.
The document discusses the components of equipment qualification for processing equipment, which include design qualification, installation qualification, operational qualification, performance qualification, and re-qualification. Design qualification establishes specifications and requirements for equipment. Installation qualification documents delivery, installation, and startup. Operational qualification verifies equipment functions as described. Performance qualification confirms equipment operates correctly and consistently for its intended use. Re-qualification is required if any critical changes are made.
This document provides an overview of GAMP (Good Automated Manufacturing Practice) guidelines for validation of computer systems used in regulated industries. It discusses the history of GAMP, key terms and concepts in validation like validation life cycle, risk management, categories of software. It also summarizes the validation requirements for different categories of software and records as per GAMP-4 guidelines. The document emphasizes that validation is important to ensure computer systems consistently produce intended results and meet safety standards.
QUALIFICATION & VALIDATION.Validation is an essential part of GMP, and an element of QA.Critical steps in the process need to be validated.Need for confidence that the product will consistently meet predetermined specifications and attributes.
Validation is required by the FDA to demonstrate that pharmaceutical manufacturing processes and equipment consistently produce quality products meeting specifications. It involves establishing documented evidence through qualification protocols that address installation, operation, and performance of processes and systems. The goals of validation are to prove quality, functionality, and reproducibility and provide high assurance that specific processes and equipment reliably produce the intended results. Pharmaceutical companies must conduct validation according to FDA guidelines tailored to their unique systems and operations.
The document provides an overview of validation requirements in the pharmaceutical industry. It defines validation and discusses where the concept came from and why it is important. Validation helps ensure quality, reduces costs, and is a regulatory requirement. The document outlines various qualification stages including design qualification, installation qualification, operational qualification, and performance qualification. It provides details on what each stage involves and key parameters to test at each stage to ensure processes and equipment are functioning as intended.
The document discusses approaches to equipment qualification for pharmaceutical manufacturing using a lifecycle approach. It outlines key points including that equipment qualification should not be a one-time event but rather consider design, demonstration, and ongoing monitoring stages. It compares traditional IQ/OQ/PQ approaches to the ASTM E2500 standard and recommends following a consistent documentation hierarchy and using model document outlines for validation projects.
The document discusses risk-based approaches in GMP (Good Manufacturing Practices) project life cycles. It describes how to identify GMP projects, the benefits of a risk-based approach, and the typical structure and implementation of a GMP project life cycle. The life cycle includes phases for project origination, initiation, planning and design, execution and control, and close-out. It provides examples of tools and documents used in each phase, as well as who is responsible for key tasks and when they should be performed to successfully implement a risk-based GMP project life cycle. An interactive exercise is proposed to help apply the concepts.
This document discusses considerations for equipment qualification when purchasing, designing, or qualifying storage units. It provides definitions of key terms related to validation and equipment qualification. The document outlines regulatory requirements for validation documentation. It discusses key validation documents including validation master plans, protocols, reports, and change control systems. Challenges in validation like inadequate specifications and planning are covered. The importance of early involvement of validation personnel and good communication for validation success is emphasized.
The Validation Master Plan (VMP) describes all validation requirements for the production facility. It covers validation aspects for all production areas, storage, utilities, and staff facilities. The VMP ensures processes will consistently produce products that meet specifications. It describes the principles of validation and organization of qualification activities and equipment.
This document provides an overview of equipment qualification terminology and processes. It discusses conducting a risk assessment to determine validation requirements and maintaining qualified equipment. The key points covered include defining user requirements, performing installation qualification to verify proper installation, and operational qualification to confirm the equipment operates as intended. Maintaining qualification involves ongoing change control and periodic review.
Validation sampling should exceed routine QA sampling based on the impact and risk analysis of the change. The protocol should specify the sampling, such as number of samples, locations, and statistical analysis, based on the risk.
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 provides a qualification protocol for bag sealing equipment. It outlines responsibilities for authoring, executing, reviewing, and approving qualification tests. The protocol scope is to establish evidence that the bag sealer is properly installed and operating according to requirements. It describes the bag sealer, lists test plans to verify installation and operation, and defines acceptance criteria. Responsibilities for personnel involved in authoring, executing, reviewing and approving the qualification tests are also defined.
In this slide contains Introduction, overview and details of FACTORY ACCEPTANCE TEST
Presented by: P.NARESH (Department of pharmaceutical analysis).RIPER, anantapur
Best Practices to Implement an Effective Change Control Program Company WideMimi V Syahputri
Understand the process/system.
Define how would you like to set your change control system based on process/system (one for all/grouping).
Categorize it (risk based approach).
Establish robust procedure with guidance.
Establish user friendly and informative form.
Establish robust data base.
Set up an effective training program.
Establish monitoring for continuous improvement.
Process validation fof Pharmaceutical dosage forms (formulation)MD NOUSHAD JAVED
This document discusses process validation for solid dosage forms such as tablets. It defines process validation as establishing documented evidence through a systematic approach to give a high degree of assurance that a specific process consistently produces quality products meeting predetermined specifications. The document outlines key steps in validation including identifying, measuring, evaluating and documenting critical process parameters to ensure quality. It discusses validation of facilities, equipment, raw materials, analytical methods and monitoring of in-process and finished product tests to control critical process variables. The document provides guidelines for validating common unit operations in solid dosage manufacturing such as mixing, granulation, drying, milling, compression, coating and encapsulation.
The document discusses current regulatory trends in the pharmaceutical industry. It mentions guidance from the FDA and ICH on quality systems and compliance. Major reasons for recalls in recent years involved GMP deviations, temperature abuse, and products marketed without approval. The document also discusses enforcement of compliance by the FDA through warning letters and inspections. It provides an overview of stages in instrument qualification and differences in perspectives between regulators and customers. Recent changes in GAMP and USP guidance are summarized as well.
Validation is the process of establishing documented evidence that a process consistently produces a product meeting its predetermined specifications and quality attributes. There are different types of validation including prospective, concurrent, and retrospective validation as well as revalidation. Process validation involves qualification steps including design qualification, installation qualification, operational qualification, and performance qualification outlined in a validation master plan. Method validation demonstrates that an analytical method is suitable for its intended purpose by testing method characteristics such as accuracy, precision, specificity, detection limit, quantitation limit, linearity, and range.
The document discusses several auxiliary facility programs that are important components of a GMP quality system, including pest control, cleaning programs, drawing control, engineering change control, spare parts management, lubricant control, and qualification of maintenance technicians and outside contractors. It emphasizes that written procedures and documentation are required for these programs to ensure facilities and equipment are properly maintained and calibrated.
The document discusses requalification and calibration processes in pharmaceutical manufacturing. It defines requalification as revalidating equipment, processes, or facilities after changes to ensure quality is not impacted. Requalification is required after significant changes like batch size changes or new equipment. Calibration verifies instrument accuracy and preventative maintenance keeps instruments qualified. A calibration program includes procedures, frequencies, tolerances and documentation of activities. Change control reviews any changes that could affect validation status and ensures continued validation. The document outlines the qualification and validation of materials, manufacturing equipment, analytical instruments and laboratory equipment used in pharmaceutical production.
This document provides information on various qualification documents used in pharmaceutical industries, including:
- User Requirement Specification (URS) which documents the end user requirements and functionality.
- Design Qualification (DQ) which verifies that the design will meet the requirements in the URS.
- Installation Qualification (IQ) which verifies proper installation.
- Operational Qualification (OQ) which tests the operation of the equipment.
- Performance Qualification (PQ) which verifies the equipment can perform as intended based on approved processes and specifications.
Guidance and requirements for each qualification type are defined. Supporting documents required for each are also listed.
The document discusses the components of equipment qualification for processing equipment, which include design qualification, installation qualification, operational qualification, performance qualification, and re-qualification. Design qualification establishes specifications and requirements for equipment. Installation qualification documents delivery, installation, and startup. Operational qualification verifies equipment functions as described. Performance qualification confirms equipment operates correctly and consistently for its intended use. Re-qualification is required if any critical changes are made.
This document provides an overview of GAMP (Good Automated Manufacturing Practice) guidelines for validation of computer systems used in regulated industries. It discusses the history of GAMP, key terms and concepts in validation like validation life cycle, risk management, categories of software. It also summarizes the validation requirements for different categories of software and records as per GAMP-4 guidelines. The document emphasizes that validation is important to ensure computer systems consistently produce intended results and meet safety standards.
QUALIFICATION & VALIDATION.Validation is an essential part of GMP, and an element of QA.Critical steps in the process need to be validated.Need for confidence that the product will consistently meet predetermined specifications and attributes.
The document discusses pharmaceutical process validation. It defines validation as proving a process consistently produces quality products. There are three main types of validation: prospective validation done before use, retrospective using historical data, and concurrent during routine production. Validation ensures quality, reduces costs, and meets regulations. It involves qualification of facilities and equipment, then protocols to test processes over multiple batches and demonstrate control. Periodic revalidation is also required when changes are made.
This document discusses validation of equipment used in pharmaceutical manufacturing. It defines validation and its objectives, which include improving reliability and safety. The main parts of validation are described as qualification including design, installation, operational, and performance qualification. Common equipment that undergo validation are listed, such as dissolution apparatus, autoclaves, and sterilization equipment. The roles of protocols, procedures, calibration, and regulatory agencies like the FDA in the validation process are also summarized.
Presentation describes the importance of IT validation from the perspectives of the FDA and our company. It explains GAMP 5, the Validation Life Cycle, good documentation practices, document naming conventions, Change Control, Problem Management, Periodic Evaluation, FDA 483 Warning Letters and 21 CFR Part 11 and a unique Validation Life Cycle.
This document discusses validation concepts including user requirement specification, phases of validation such as design qualification, installation qualification, operational qualification, performance qualification, and maintenance qualification. It provides definitions and guidelines for each phase. The key phases involve design qualification to define functional specifications, installation qualification to ensure proper installation, operational qualification to test functions, performance qualification to ensure consistent performance over time, and maintenance qualification to document maintenance. The overall goal of validation is to provide high assurance that a process will consistently produce quality products meeting specifications.
In the last year or so the FDA and the EMA have issued new guidance/ draft guidance on "Process Validation".These align process validation activities with a product lifecycle concept and the International Conference on Harmonisation (ICH) guidances for industry, Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System. The earlier guidelines were developed before the elaboration of the new ICH guidelines.With these new guidelines, additional opportunities are available to verify the control of the process by alternative means to the manufacture of traditional process validation batches. The main objective of process validation remains that a process design yields a product meeting its pre-defined quality criteria. ICH Q8, Q9 and Q10 provide a structured way to define product critical quality attributes, design space, the manufacturing process and the control strategy. ICH Q8 refers to an ‘enhanced’ approach to pharmaceutical development which includes an alternative to the traditional process validation.
Continuous process verification [see definition in ICH Q8(R2) glossary] can be utilised in process validation protocols for the initial commercial production and for manufacturing process changes for the continual improvement throughout the remainder of the product lifecycle.
There is now a new paradigm in process validation. This presentation has been prepared from material available from FDA , EMA and ICH for beginners to have an overview of the new paradigm.
This document outlines the process of validation for non-sterile pharmaceutical products. It discusses prospective validation, which involves validating the production process prior to releasing finished product for sale, concurrent validation during routine production, and retrospective validation which involves reviewing historical data. The key steps are identifying critical process parameters, conducting validation protocols with predetermined acceptance criteria, and documenting results in a validation report.
This document provides an overview of validation principles from a WHO technical report. It discusses the scope and objectives of validation, including qualification of equipment, utilities, and processes. The key aspects covered are approaches to validation, documentation requirements, and revalidation procedures.
The document provides an overview of a training module on the qualification and validation of HVAC systems used in manufacturing facilities. It discusses key concepts like commissioning, qualification, documentation requirements, design qualification, installation qualification, operational qualification, performance qualification, monitoring programs, and maintenance. The module aims to help understanding of critical issues for HVAC systems and how their proper design, installation, and maintenance can ensure the quality of pharmaceutical products manufactured.
This document discusses equipment qualification, which involves verifying through inspections and tests that critical equipment can satisfy product quality requirements and is properly operated and maintained. It is a regulatory requirement and includes design qualification, installation qualification, operational qualification, and performance qualification. Design qualification verifies a design is suitable, installation qualification verifies proper installation, operational qualification verifies performance within operating ranges, and performance qualification verifies effective and reproducible performance of connected equipment and systems based on approved processes. The document provides details on the stages, requirements, and documentation for each type of qualification.
This document discusses validation and qualification processes for pharmaceutical equipment and systems. It defines validation as providing objective evidence that a process meets its intended use consistently, while qualification ensures equipment is ready for its intended use. The document outlines the key steps in validation including developing a validation master plan, user requirement specification, design qualification, installation qualification, operational qualification and performance qualification. It provides details on each stage and emphasizes that validation and qualification are critical to ensuring product quality and compliance with cGMP regulations.
The Validation Master Plan (VMP) outlines the company's approach to validation. It defines responsibilities, schedules, and documentation requirements for qualification of facilities, equipment, and processes. The VMP ensures management understands validation needs and the validation team understands their tasks. Key elements include qualification protocols for equipment operational performance and process validation protocols to demonstrate processes consistently meet requirements. The VMP is a living document that is updated with changes to facilities, equipment, or processes.
The Validation Master Plan (VMP) outlines the company's approach to validation. It defines responsibilities, schedules, and documentation requirements for qualification of facilities, equipment, and processes. The VMP ensures management understands validation needs and the validation team understands their tasks. Key elements include qualification of equipment and facilities, process validation, cleaning validation, change control procedures, and periodic revalidation. Qualification includes design, installation, operational, and performance qualification to confirm equipment and facilities operate as intended. Process validation demonstrates manufacturing processes consistently produce products meeting specifications. The VMP helps regulatory inspectors evaluate the company's validation program.
This document discusses process validation in API facilities. It defines validation and describes the different types of validation including analytical tests, equipment, process, and support process validation. It also discusses facility systems validation including design qualification, installation qualification, operational qualification, and performance qualification. The types of validation including prospective, concurrent and retrospective are described. Process validation is important to demonstrate process control and consistency and comply with regulatory requirements. Process validation requires identifying critical process parameters and critical quality attributes.
Facility Qualification & Consideration of Validation Aspects Apoorva Bauskar
This document discusses various aspects of facility qualification including validation master plans, user requirement specifications, design qualifications, installation qualifications, operational qualifications, performance qualifications, and requalification. It emphasizes that qualification proves systems work correctly and as expected. Validation plans encompass all validation aspects for facilities and equipment. User requirements specify functional and operational needs. Design reviews verify design suitability. Installation and operational qualifications check that systems are installed and perform as intended. Performance qualifications demonstrate effective performance under routine conditions. Requalification occurs on a defined schedule. Change control reviews changes that could affect validation status. Comprehensive documentation is also needed.
The document discusses the qualification of equipment in the pharmaceutical industry. It defines equipment qualification as ensuring critical requirements are met and necessary documents and procedures are in place. The stages of qualification include user requirement specifications, design qualification, factory acceptance testing, site acceptance testing, installation qualification, operational qualification, and performance qualification. Utilities like HVAC systems, water systems, and gases must also undergo qualification to demonstrate consistent performance.
the various categories of qualifications necessary for Validating an equipment or instrument before & after installation. Those are
DQ(Design Qualification)
IQ(Installation Qualification)
OQ(Operation Qualification)
PQ(Performance Qualification)
This document outlines validation and calibration master plans. It discusses the objectives of validation including reducing risks and costs. It describes the contents and members involved in a validation master plan, which provides the framework for validation activities. It also discusses the calibration process, including defining calibrated equipment, classification, and verification. The calibration master plan establishes requirements for an effective calibration control program.
The document discusses analytical instrument qualification (AIQ) in the pharmaceutical industry. It states that AIQ involves collecting evidence that an instrument is suitable for its intended purpose. The key phases of AIQ are design qualification, installation qualification, operational qualification, and performance qualification. It also discusses the roles and responsibilities of various parties in ensuring instruments are properly qualified.
This document provides guidelines on validation and qualification for pharmaceutical manufacturing. It discusses the importance of validation in ensuring quality products. Key aspects covered include the relationship between validation and qualification, approaches to validation, scope of validation, and calibration. Appendices provide more specific guidance on validation of areas like cleaning, computer systems, equipment, and analytical methods. The overall goal is to help manufacturers design validated processes to consistently produce safe, effective pharmaceuticals.
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
This document discusses process validation in the pharmaceutical industry. It defines process validation and describes it as having three stages: process design, process qualification, and continued process verification. The objectives and requirements of each stage are explained. Process validation helps ensure a process consistently produces products meeting specifications and quality attributes. It involves understanding and controlling sources of variation. Validation protocols, reports, teams, and the lifecycle are also reviewed to explain how process validation is planned and documented.
This document discusses validation of pharmaceutical manufacturing processes and equipment. It covers the phases of validation including design qualification, installation qualification, operational qualification, performance qualification, and maintenance qualification. User requirement specification is identified as a critical document for validation. Guidelines are provided for developing the user requirements specification to include requirements that are testable and unambiguous. The roles of qualification and validation in ensuring validated equipment and processes are also summarized.
Qualification of Laboratory Equipments.pptxHemlataMore3
This document discusses equipment qualification and provides details on the key aspects: design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). It defines these qualification types and describes their objectives. For example, DQ defines functional specifications, IQ verifies correct installation, OQ demonstrates functions work as specified, and PQ ensures consistent performance under normal operating conditions. The document also discusses applying these qualifications to dissolution test apparatus to ensure quality and regulatory compliance. It stresses the importance of documentation systems for locating documents quickly.
1. Supplementary Training Modules on
Good Manufacturing Practice
Validation
WHO Technical Report Series,
No. 937, 2006. Annex 4.
Validation | Slide 1 of 27 August 2006
2. Validation
Part 1. General overview on qualification and validation
Part 2. Qualification of HVAC and water systems
Part 3. Cleaning validation
Part 4. Analytical method validation
Part 5. Computerized system validation
Part 6. Qualification of systems and equipment
Part 7. Non sterile product process validation
Validation | Slide 2 of 27 August 2006
3. Supplementary Training Modules on
Good Manufacturing Practice
Qualification of systems
and equipment
Part 6
WHO Technical Report Series, No. 937,
2006. Annex 4. Appendix 6.
Validation | Slide 3 of 27 August 2006
4. Validation
Objectives
To discuss the principles of qualification of systems and
equipment, with specific focus on:
The different stages of qualification
Requalification and
Qualification of “in use” systems and equipment
Validation | Slide 4 of 27 August 2006
5. Validation
Principle
Systems and equipment: Appropriately designed, located,
installed, operated and maintained
Critical systems and equipment – should be qualified
May include, where appropriate:
– Water purification systems, air-handling systems,
autoclaves, coating machines
Continued suitable performance needed
– Why? To ensure batch-to-batch consistency
1.1 – 1.3
Validation | Slide 5 of 27 August 2006
6. Validation
Scope
Guidelines describe the general aspects of qualification for
systems and equipment
Normally qualification would be applicable to critical systems
and equipment whose performance may have an impact on the
quality of the product
2.1 – 2.2
Validation | Slide 6 of 27 August 2006
7. Validation
General
Qualification policy for systems and equipment
To include instruments used in production and quality control
New systems and equipment: All stages of qualification
applicable (DQ, IQ, OQ and PQ)
In some cases: Not all stages of qualification may be required
– e.g. electrical supply systems
3.1 – 3.4
Validation | Slide 7 of 27 August 2006
8. Validation
General (continued)
Systems: Qualified before equipment
Equipment: Qualified before routine use
Systems and equipment: Periodic requalification, as well as
requalification after change
Certain stages done by the supplier or a third party
Maintain the relevant documentation, e.g.
– standard operating procedures (SOPs), specifications and
acceptance criteria, certificates and manuals 3.5 – 3.9
Validation | Slide 8 of 27 August 2006
9. Validation
General (continued)
Qualification should be done in accordance with predetermined
and approved qualification protocols
The results of the qualification should be recorded and reflected
in qualification reports
The extent of the qualification should be based on the criticality
of a system or equipment, e.g.
– Blenders, autoclaves or computerized systems
3.10 – 3.11
Validation | Slide 9 of 27 August 2006
10. Validation
Blender
Discuss the approach of
qualification of a newly
installed blender
Validation | Slide 10 of 27 August 2006
11. Validation
Stages of qualification
Design qualification
Installation qualification
Operational qualification
Performance qualification
3.11
Validation | Slide 11 of 27 August 2006
12. Validation
Stages of qualification
Design qualification
Installation qualification
Operational qualification
Performance qualification Change control
3.11.
Validation | Slide 12 of 27 August 2006
13. Validation
Design qualification
User requirements should be considered when deciding on the
specific design of a system or equipment
A suitable supplier should be selected for the appropriate
system or equipment (approved vendor)
4.1 – 4.2
Validation | Slide 13 of 27 August 2006
14. Validation
Installation qualification
Correct installation as per plan and protocol
Normally advised to prepare requirements for calibration,
maintenance and cleaning at this stage
Identification and verification of all system elements, parts,
services, controls, gauges and other components
Calibrate the measuring, control and indicating devices
– against appropriate, traceable national or international
standards
5.1 – 5.4
Validation | Slide 14 of 27 August 2006
15. Validation
Installation qualification (2)
Documented records for the installation
– installation qualification report
Indicate satisfactory installation
Include details, e.g.
– The supplier and manufacturer
– System or equipment name, model and serial number
– Date of installation
– Spare parts, relevant procedures and certificates
5.5
Validation | Slide 15 of 27 August 2006
16. Validation
The handout shows a typical format for
"An installation qualification protocol / report"
It reflects the minimum information that should be included
This is an example – and should be used as such
Specific formats need to be designed for a specific system or
piece of equipment
5.5
Validation | Slide 16 of 27 August 2006
17. Validation
Operational qualification
Systems and equipment should operate correctly – operation
verified as in the qualification protocol
Studies on critical variable to include conditions encompassing
upper and lower operating limits and circumstances (i.e.
“worst case conditions”)
To include verification of operation of all system elements, parts,
services, controls, gauges and other components
6.1 – 6.3
Validation | Slide 17 of 27 August 2006
18. Validation
Operational qualification (2)
Documented records (Operational qualification report)
Finalize and approve SOP (operation)
Training of operators provided – training records
Systems and equipment released for routine use after
completion of operational qualification, provided that:
– All calibration, cleaning, maintenance, training and related
tests and results were found to be acceptable
6.4 – 6.7
Validation | Slide 18 of 27 August 2006
19. Validation
The handout shows a typical format for:
"An operational qualification protocol / report"
It reflects the minimum information that should be included
This is an example – and should be used as such
Specific formats need to be designed for a specific system or
piece of equipment
6.7
Validation | Slide 19 of 27 August 2006
20. Validation
Performance qualification
Systems and equipment should consistently perform in
accordance with design specifications – verified in accordance
with a performance qualification protocol
Documented records – performance qualification report
Show satisfactory performance over a period of time
Manufacturers to justify the selected period
7.1 – 7.2
Validation | Slide 20 of 27 August 2006
21. Validation
The handout shows a typical format for:
"A performance qualification protocol / report"
It reflects the minimum information that should be included
This is an example – and should be used as such
Specific formats need to be designed for a specific system or
piece of equipment
7.2
Validation | Slide 21 of 27 August 2006
22. Validation
Defined schedule
Periodic
Requalification After change
8.1 – 8.3
Validation | Slide 22 of 27 August 2006
23. Validation
Results of calibration
Defined schedule , maintenance
verification
Frequency based on
Factors
Periodic
Requalification After change
Extent based on
Risk assessment
Part of
Change control procedure
8.1 – 8.3
Validation | Slide 23 of 27 August 2006
24. Validation
What about "old manufacturers" who have not
performed DQ, or IQ for existing, in-use systems
and/or equipment?
Validation | Slide 24 of 27 August 2006
25. Validation
Qualification of “in-use” systems and equipment
Data to support and verify the suitable operation and
performance of systems and equipment
Should include operating parameters and limits for critical
variables, calibration, maintenance and preventive maintenance,
standard operating procedures (SOPs) and records
9.1 – 9.2
Validation | Slide 25 of 27 August 2006
27. Validation
Group session
Validation | Slide 27 of 27 August 2006
Editor's Notes
दिसंबर 4, 2012 In this supplementary training module, we will be looking at the recommendations by WHO, on Validation and qualification. The module consists of 7 parts: Part 1. General overview on qualification and validation Part 2. Qualification of HVAC and water systems Part 3. Cleaning validation Part 4. Analytical method validation Part 5. Computerized system validation Part 6. Qualification of systems and equipment Part 7. Non sterile product process validation Each part deals with a specific topic, and each part can be presented in about one to one and a half hours time. Presenters should know the topics and add practical examples to the texts taken from the WHO guideline.
दिसंबर 4, 2012
दिसंबर 4, 2012
दिसंबर 4, 2012 Qualification of systems and equipment 1. Principle 2. Scope 3. General 4. Design qualification 5. Installation qualification 6. Operational qualification 7. Performance qualification 8. Requalification 9. Qualification of “in use” systems and equipment
दिसंबर 4, 2012 Principle 1.1 Systems and equipment should be appropriately designed, located, installed, operated and maintained to suit their intended purpose. 1.2 Critical systems, i.e. those whose consistent performance may have an impact on the quality of products, should be qualified. These may include, where appropriate, water purification systems, air-handling systems, compressed air systems and steam systems. 1.3 The continued suitable performance of equipment is important to ensure batch-to-batch consistency. Critical equipment should therefore be qualified.
दिसंबर 4, 2012 Scope Guidelines describe the general aspects of qualification for systems and equipment. Normally qualification would be applicable to critical systems and equipment whose performance may have an impact on the quality of the product.
दिसंबर 4, 2012 General Qualification policy for systems and equipment. To include instruments used in production and quality control. New systems and equipment: All stages of qualification applicable (DQ, IQ, OQ and PQ). In some cases: Not all stages of qualification may be required. E.g. electrical supply systems.
दिसंबर 4, 2012 Systems should be qualified before equipment. 3.6 Equipment should be qualified prior to being brought into routineuse to provide documented evidence that the equipment is fi t for its intended purpose. 3.7 Systems and equipment should undergo periodic requalification, as well as requalification after change. 3.8 Certain stages of the equipment qualification may be done by the supplier or a third party. 3.9 The relevant documentation associated with qualification including standard operating procedures (SOPs), specifications and acceptance criteria, certificates and manuals should be maintained. 3.10 Qualification should be done in accordance with predetermined and approved qualification protocols. The results of the qualification should be recorded and reflected in qualification reports. 3.11 The extent of the qualification should be based on the criticality of a system or equipment (e.g. blenders, autoclaves or computerized systems). S
दिसंबर 4, 2012 3.10 Qualification should be done in accordance with predetermined and approved qualification protocols. The results of the qualification should be recorded and reflected in qualification reports. 3.11 The extent of the qualification should be based on the criticality of a system or equipment (e.g. blenders, autoclaves or computerized systems).
The trainer should invite discussion from participants on the approach, stages, parameters to be considered in the qualification of equipment. Use examples of pieces of equipment.
दिसंबर 4, 2012 Stages of qualification There are generally, four stages in qualification. Can you name them? Design qualification Installation qualification Operational qualification Performance qualification Change control We will look into more detail on these stages in the next slides.
दिसंबर 4, 2012 Stages of qualification There are generally, four stages in qualification. Can you name them? Design qualification Installation qualification Operational qualification Performance qualification Change control We will look into more detail on these stages in the next slides.
दिसंबर 4, 2012 Design qualification User requirements should be considered when deciding on the specific design of a system or equipment. A suitable supplier should be selected for the appropriate system or equipment (approved vendor).
दिसंबर 4, 2012 Installation qualification 5.1 Systems and equipment should be correctly installed in accordance with an installation plan and installation qualification protocol. 5.2 Requirements for calibration, maintenance and cleaning should be drawn up during installation. 5.3 Installation qualification should include identification and verification of all system elements, parts, services, controls, gauges and other components. 5.4 Measuring, control and indicating devices should be calibrated against appropriate national or international standards, which are traceable.
दिसंबर 4, 2012 5.5 There should be documented records for the installation (installation qualification report) to indicate the satisfactoriness of the installation, which should include the details of the supplier and manufacturer, system or equipment name, model and serial number, date of installation, spare parts, relevant procedures and certificates.
दिसंबर 4, 2012
दिसंबर 4, 2012 Operational qualification Systems and equipment should operate correctly - operation verified as in the qualification protocol. Studies on critical variable to include conditions encompassing upper and lower operating limits and circumstances (that is “worst case conditions”). To include verification of operation of all system elements, parts, services, controls, gauges and other components.
दिसंबर 4, 2012 6.4 There should be documented records for the verification of operation (operational qualification report) to indicate the satisfactory operation. 6.5 Standard operating procedures for the operation should be finalized and approved. 6.6 Training of operators for the systems and equipment should be provided, and training records maintained. 6.7 Systems and equipment should be released for routine use after completion of operational qualification, provided that all calibration, cleaning, maintenance, training and related tests and results were found to be acceptable.
दिसंबर 4, 2012
दिसंबर 4, 2012 Performance qualification Systems and equipment should consistently perform in accordance with design specifications - verified in accordance with a performance qualification protocol. Documented records - performance qualification report. Show satisfactory performance over a period of time . Manufacturers to justify the selected period.
दिसंबर 4, 2012
दिसंबर 4, 2012 The manufacturer should have a policy on requalification. It should cover periodic requalification as well requalification after change .
दिसंबर 4, 2012 Requalification 8.1 Requalification of systems and equipment should be done in accordance with a defined schedule. The frequency of requalification may be determined on the basis of factors such as the analysis of results relating to calibration, verification and maintenance. 8.2 There should be periodic requalification. 8.3 There should be requalification after changes. The extent of requalification after the change should be justified based on a risk-assessment of the change. Requalification after change should be considered as part of the change control procedure.
दिसंबर 4, 2012
दिसंबर 4, 2012 Qualification of “in-use” systems and equipment The manufacturer should have data to support and verify the suitable operation and performance of systems and equipment. This should include operating parameters and limits for critical variables, calibration, maintenance and preventive maintenance, standard operating procedures (SOPs) and records. On the basis of this, OQ and PQ could be done (protocol and reports prepared). Remember – can still do requalification!
Group session (Example) The trainer could ask the participants to discuss the approach of qualification for a piece of equipment. Present the participants with a schematic drawing of equipment, or a manual and related documentation, and ask them to discuss key aspects in the different stages of qualification.
दिसंबर 4, 2012 The presenter should prepare case studies for the groups on qualification of systems and equipment . Participants could discuss qualification requirements for systems e.g. steam generators for autoclaves, qualification of critical equipment including coating machines, compression machines, autoclaves, dry heat sterilizers etc .