Equipment validation (or validation) and system validation, cleaning validation, analysis method validation, etc. that need to be completed prior to implementation of the process validation are not covered by this sharing (excluding, for example, inconsistencies between registered and actual processes).
How to do a good job of process verification? A person or a department can do a good job of verification? In the forum often see a verification manager to complete the company's full verification documents (programs and reports), such a verification can be done to be discussed!
Validation is an inter-departmental work that is related to multiple departments and requires close cooperation of relevant departments. Therefore, we must have a team for the verification of the concept of verification, which is a necessary precondition for verification (Note: For the whole company to verify a single person or a department to complete, while trying to do their own, and your Leading communication to allow more relevant personnel involved). It is important to verify this.
Here I elaborate on my understanding of process validation in several ways:
1. First of all, verify the plan, the plan is to do from the bottom up, that is to say each workshop to be the unit to do the process Verification Plan your own plan according to the production plan and the specific conditions of the workshop, submit the uniform balance to the quality manager in charge, and draw up the company's total process verification plan. Pay attention to the time node and possible changes here, and list as far as practicable annual total Planned, submitted to the production and quality of the responsible person approved issued to the relevant departments, the quality of the department responsible for the verification of tracking the total list of projects to be completed each month, in time to track the completion of the situation, do all aspects of communication and coordination (Note , The Quality Assurance Manager is not the person who drafted the program and the report, is the audit and coordination);
2. With regard to the assignment of responsibility, although there are provisions in the verification management or verification master plan, those who are not generally involved in the verification of verification for the specific verification implementation should take note of the specific work involved in drafting the verification plan and audit To be implemented to specific people, but also training in place, so that each involved a verification program to identify their own responsibilities, in advance to prepare for validation in the smooth progress. Develop habits that form a process that can validate validation as planned.
3. Process validation required to be completed before the implementation of the project: This in your company documents will be clearly defined.
(1) The key quality attributes and the key process parameters have been determined; the documents related to the verification are to confirm whether the current version (including process rules, SOPs of all processes, all records (batch production records, batch inspection records, cleaning records, equipment operation records, etc.) standards, testing procedures);
verify or confirm ⑵ plant facilities, systems and equipment (including calibration or verification of measuring instruments, analytical method validation and product testing equipment validation or confirmation) has been completed;
⑶ involved in the implementation process validation of all personnel Of the training has been completed (aseptic preparations to complete the dressing to confirm the replacement of sterile staff), the person in charge is responsible for the organization of process validation training, the drafters are responsible for training programs;
⑷ process validation materials and packaging materials tested and qualified (Such as: operating room and equipment and site environment to meet the technical requirements; public system to meet the technical requirements (process water, air, nitrogen and purification system test results pass)
4. process validation program (report) drafting
process validation Drafters To have sufficient knowledge of product technology, research Metastasis to the process of production verification by the R & D process development personnel and production units craft jointly drafted (involving changes have jointly drafted); Process daily production and product verification drafted by the manufacturer, the production unit processes the person in charge;
5. verification Implementation of
process validation by the approval of the validation program one by one implementation of the production workshop responsible person to do a good job plan staff distribution, craft and QA do a good job of verifying the process of data collection records consolidation analysis, tracking control of intermediates, to verify the process Change and deviation processing.
6. Verification Report Drafting:
Most enterprises are QA to carry out the verification report drafting, I suggest that the workshop technicians and QA co-drafting, statistical analysis of key process parameters by the craftsmen to do, intermediate and finished product indicators from the QC statistical analysis, QA summarizes all verification records and concludes.
The quality manager and production manager will review and approve the verification report.
7. Process validation status of the maintenance of
7.1 End of the verification batch of commercial production, pay attention to daily routine key process parameters and quality indicators of statistical analysis (production units for statistical analysis of process parameters; QC quality indicators for statistical analysis; QA regular collection Data such as monthly or quarterly assessment, defect detection, timely correction);
7.2 verification to complete the following conditions to assess whether to re-verify:
7.2.1 production process has changed;
7.2.2 raw materials, packaging materials have changed (Including manufacturer's changes) may affect the quality of the product;
7.2.3 Equipment and facilities have major changes;
8. Process validation program included
Case 1 Sterile preparation
cover: Verification program name, number, version Approval; Drafting, Reviewing (Heads of Related Authorities), Approval
1. Purpose
2. Scope
3. Responsibilities
Available in List Form
Name Title Duties
4. Referenced legislation and guidance
typically include: Good Manufacturing Practices 2010 Edition ";" Guidelines for the Implementation of Quality Control of Pharmaceutical Production "(2011 edition); "Guide to the Validation of Pharmaceutical Production" (2003 Edition); " Chinese Pharmacopoeia " (2010 Edition) and the Company's Verification Master Plan and Validation Management Rules.
5. Product Overview (Product Overview (Product Category, Clinical Use, Registration, Registered Process Change Information and Production History) and Process Description (Formulation, Process Flow Chart)
6. Pre-Validation Verification
6.1 Validation of Production Environment and Facilities Humidity, pressure differential confirmation, cleanliness test results meet the requirements of the appropriate level of clean area; confirm the public facilities (air purification system, purified water and water system for injection, air compression system) has been verified to meet the requirements)
6.2 production equipment to confirm (whether the main equipment Verify and comply with the regulations, you can list the description)
6.3 Preparation of documents (documents related to process validation check, list confirmation, pay attention to if the new plant process and cleaning procedures may be approved draft)
6.4 Verification of equipment and instrument calibration Instruments, meters, measuring instruments have been confirmed or verified and within the validity period)
6.5 Participate in the verification of the verification personnel (personnel training: list all participants to attend this certification list, check the training files to confirm whether the staff involved in the verification Training? Training is qualified? : Authentication scheme; GMP(2010) basic knowledge, basic knowledge of microbiology, where the jobs and equipment operation, maintenance, cleaning SOP; staff out of the general production area clean areas and standard operating procedures; enter the sterile area, dressing confirm Meet the requirements, access to the confirmation report and health records; Acceptance criteria: confirm whether the post operator certificate holder;)
6.6 verification of the confirmation of the materials used (raw materials and packaging materials, list description: material name, material code, quality standards, test results )
7. Sampling plan and evaluation criteria
can be centralized list description can also be described separately in each process
8. Process Verification Implementation of the
process specification Brief
process flow to confirm the key process parameters
8.1 Bottle sterilization (brief purposes; Operational requirements and record requirements; list itemized verification items, standards; evaluation requirements)
8.2 rubber stopper cleaning, sterilization (for the purpose of brief; operation requirements and record requirements; list itemized verification items, standards; evaluation requirements)
8.3 Weighing, preparation of filtering (brief purposes; operational requirements and recording requirements; Item to write out the verification items, standards, evaluation requirements)
8.4 Filling (Brief description purpose; Operation requirements and record requirements; List itemized verification items, standards; Evaluation requirements. Operation and process monitoring; filling and cleaning tools after sterilization transfer)
8.5 freeze-dried (brief purposes; operational requirements and record requirements; list itemized verification items, standards; evaluation requirements.
8.6 cover (brief purposes; operation requirements and record requirements; list itemized verification items, standards; evaluation requirements. Including the production environment, sterilization parameters, disinfection procedures, equipment operation and process monitoring; and metastasis)
8.7 light inspection (Objective: confirmation light detecting remove substandard quality product performance, process light inspection good product is not formed and nonconforming Confusion; the implementation of "lamp inspection post SOP." And light inspection machine SOP, the operation of the process recorded in a timely manner light inspection records; Project and standards: aluminum cover and bottle: Capping tight, No cracks, no foreign body outside the bottle wall; bottle: colorless point, no glass crumbs or other foreign matter, powder no discoloration, no crystal bottom shape, pinch waist phenomenon; can remove empty bottles, liquid glue wall, Plug, there are significant differences in the amount of product or have other problems. Record the results of the verification, the evaluation gives the conclusion, if deviations, according to the deviation processing program execution).
8.8 packaging (summary purpose; operational requirements and record requirements; list item by item to write out the verification project, standards; evaluation requirements)
8.9 total material balance (brief purpose; material balance range; evaluation requirements)
9. Finished Product Quality Inspection and Stability Test (Purpose: To confirm whether the products manufactured according to the manufacturing process of the product meet the statutory standards and internal control standards.) Operation and Record Requirements: To examine the inspection records and inspection reports of the products, Standard and internal control standards are checked item by item, the test results are within acceptable limits, recorded in the verification records and compared with the last verified batch, the product quality is evaluated, and the stability test is added if necessary.
10. Deviation Report (Determine the processing requirements in case of deviations in the verification process)
11. Evaluation and its conclusion (The verification team makes the final evaluation based on the verification results and make corresponding assessment and conclusion according to the verification conditions.)
12. Verification Status Maintenance (Revalidation )
attachments: process flow diagrams; sampling plan; risk assessment report. Process verification process records, deviation records and other
product process verification report
Cover: verify the report name, number, version number; approval: drafting, review (relevant department heads), to approve the
process verification program to provide records of all test items Have been completed and are attached to the Summary Report to certify that all changes and deviations have been documented and approved and are attached to the report and submitted for approval. The report includes:
Verification Implementation Description:
1. Validation of Program Implementation Start and End Time , validation lot information (lot number, production)
2. verify embodiment is briefly
3. verify process embodiments: by recording and evaluating programs (recorded programs completion table) for each of the results, trend analysis, if necessary;
4. Finally, the entire verification is summarized and evaluated. The evaluation results are attached to the report.
5. Revalidation
Tuesday, December 19, 2017
Monday, December 18, 2017
Process validation for the pharmaceutical industry
Concept validation
defines validation GMP is "Establishing documented evidence that provides a high degree of assurance that a specific process will consistently a product meeting its predetermined specifications and quality attributes."
proper and complete documentation is recognized as critical to the validation effort. Standard Operating Procedures (SOPs), manufacturing formulas, detailed documentation of the batch, change control systems, investigative reporting systems, analytical documentation, report development, validation protocols and reports are part of the validation of philosophy. The validation documentation provides a source of information for the current installation in operation and is a resource that is used in the development of subsequent process or modification activities.
All validation activities will include a level of impact assessment to ensure that the systems, services and products directly influenced by trials were identified.
A rehabilitation program should be implemented in routine basic equipment revalidation requirements and the change control policy.
Types of Validation
Prospective Validation
Establishing documented evidence that a piece of equipment / process or system will do what it claims to do, based on a series of pre-planned scientific tests as defined in the validation plan.
Concurrent validation
occupied East when an existing process can be localized in a control state by applying tests on samples at strategic points through a process, and at the end of the process. All data collected at the same time that the implementation of the procedure until the available information is sufficient to demonstrate the reproducibility of the process.
Retrospective Validation
Establishing documented evidence that the process does what it claims to do, based on review and analysis of historical data.
Design qualification (DQ)
The purpose of the DQ is encountered in the design and commissioning of a number of mechanisms, which include:
- Specification Generation of user requirements
- Verification that the design meets the relevant specifications of user requirements.
Evaluation of suppliers / Checks -
- Challenge design by GMP review audits
- Assessing the impact of product quality
- Specifying the documentation requirements for validation of equipment suppliers
- Agreement with suppliers on performance targets
- factory acceptance tests (FAT), site acceptance test (SAT) and commissioning procedures
- definition of the construction and the installation documentation to help installation Qualification (IQ).
Installation Qualification (IQ)
IQ provides documented evidence that the equipment or system has been developed, supplied and installed in accordance with design drawings, vendor Advice and internal needs. In addition, IQ ensures that the file of the main characteristics of the equipment or system, as installed, is available and it is supported by adequate documentation sufficient to allow satisfactory operation of control, the maintenance and change to implement.
Operational Qualification (OQ)
OQ provides documented evidence that the equipment works as intended throughout the specific design, operational or acceptance range of approved equipment, where applicable. In cases where the process steps are tested, a suitable placebo lot is used to demonstrate the functionality of equipment.
Any new equipment must be fully commissioned before the start of OQ ensure that, at minimum, the equipment is safe to operate, all mechanical assemblies and pre-qualification audits were completed, the hardware is fully functional and that the documentation is complete.
Performance Qualification (PQ)
The purpose of the PQ is to provide documented evidence that the equipment can still achieve and maintain its performance specifications over an extended operating period at a defined operating point to produce a pre-determined product quality. The performance specification will reference the process parameters during manufacturing and product specifications. PQ requires three lots of products to meet all acceptance criteria for in-process and product testing. For utility systems, PQ requires the utility carrier to meet all specifications over a long sample period.
PQ documentation should refer to standard manufacturing procedures and batch records and describe the sampling methodology and testing to use.
This is validated
General
All process steps, production equipment, systems and the environment, directly used in the manufacture of products sterile and non-sterile products must be formally validated.
All major packaging materials and processes must be validated. This validation is less complete.
All auxiliary systems that are not directly impact the quality of the product must be qualified through technical documentation of the extent of the system and how it works.
Easy
- Area Design Manufacturing.
- Personnel and material flow, etc.
Process and equipment design
steps of the process and the description of the equipment. ie distribution, formulation, washing of the packaging equipment,
and cleaning. etc.
Systems design Utility
Raw / purified steam, purified water, etc. waste compressed air, air conditioning system, vacuum, power, lighting, cooling water,
Designing computer systems
information system, automated laboratory equipment, manufacture of automated industrial equipment, electronics, etc. files
Cleaning validation (CV)
CV provides documentary evidence that a cleaning procedure is effective in reducing pre-defined maximum tolerable limits, all chemical and microbiological contamination from a piece of equipment or a manufacturing area following the treatment. The way to assess the cleaning efficiency involves sampling cleaned and disinfected surfaces and check the level of product residues, cleaning residues and bacterial contamination.
The CV term should be used to describe the analytical investigation of a procedure or cleaning cycle. The validation protocols must refer to the basic documentation relating to the justification of "worst case" testing when it is offered. It must also explain the development of acceptance criteria, including chemical and microbial specifications, limits of detection and selection of sampling methods.
Method Validation (MV)
MV provides documented evidence that the test methods developed internally are accurate, robust, efficient, reproducible and repeatable. The validation protocols must refer to the basic documentation relating to the justification of determining detection sensitivity limits and method.
Computer Validation
Computer Validation provides documented evidence to ensure systems will still function according to their predetermined specifications and quality attributes, throughout their life cycle. Important aspects of this validation process are the formal design management (through a process of specification); quality system (through a systematic review and analysis), risk (through the identification and evaluation of new and critical feature) and life cycle (through control lasting change).
When the equipment is controlled by embedded computer systems, computer validation elements can be performed as part of the equipment and IQ OQ protocols.
...................................................................................................................................
defines validation GMP is "Establishing documented evidence that provides a high degree of assurance that a specific process will consistently a product meeting its predetermined specifications and quality attributes."
proper and complete documentation is recognized as critical to the validation effort. Standard Operating Procedures (SOPs), manufacturing formulas, detailed documentation of the batch, change control systems, investigative reporting systems, analytical documentation, report development, validation protocols and reports are part of the validation of philosophy. The validation documentation provides a source of information for the current installation in operation and is a resource that is used in the development of subsequent process or modification activities.
All validation activities will include a level of impact assessment to ensure that the systems, services and products directly influenced by trials were identified.
A rehabilitation program should be implemented in routine basic equipment revalidation requirements and the change control policy.
Types of Validation
Prospective Validation
Establishing documented evidence that a piece of equipment / process or system will do what it claims to do, based on a series of pre-planned scientific tests as defined in the validation plan.
Concurrent validation
occupied East when an existing process can be localized in a control state by applying tests on samples at strategic points through a process, and at the end of the process. All data collected at the same time that the implementation of the procedure until the available information is sufficient to demonstrate the reproducibility of the process.
Retrospective Validation
Establishing documented evidence that the process does what it claims to do, based on review and analysis of historical data.
Design qualification (DQ)
The purpose of the DQ is encountered in the design and commissioning of a number of mechanisms, which include:
- Specification Generation of user requirements
- Verification that the design meets the relevant specifications of user requirements.
Evaluation of suppliers / Checks -
- Challenge design by GMP review audits
- Assessing the impact of product quality
- Specifying the documentation requirements for validation of equipment suppliers
- Agreement with suppliers on performance targets
- factory acceptance tests (FAT), site acceptance test (SAT) and commissioning procedures
- definition of the construction and the installation documentation to help installation Qualification (IQ).
Installation Qualification (IQ)
IQ provides documented evidence that the equipment or system has been developed, supplied and installed in accordance with design drawings, vendor Advice and internal needs. In addition, IQ ensures that the file of the main characteristics of the equipment or system, as installed, is available and it is supported by adequate documentation sufficient to allow satisfactory operation of control, the maintenance and change to implement.
Operational Qualification (OQ)
OQ provides documented evidence that the equipment works as intended throughout the specific design, operational or acceptance range of approved equipment, where applicable. In cases where the process steps are tested, a suitable placebo lot is used to demonstrate the functionality of equipment.
Any new equipment must be fully commissioned before the start of OQ ensure that, at minimum, the equipment is safe to operate, all mechanical assemblies and pre-qualification audits were completed, the hardware is fully functional and that the documentation is complete.
Performance Qualification (PQ)
The purpose of the PQ is to provide documented evidence that the equipment can still achieve and maintain its performance specifications over an extended operating period at a defined operating point to produce a pre-determined product quality. The performance specification will reference the process parameters during manufacturing and product specifications. PQ requires three lots of products to meet all acceptance criteria for in-process and product testing. For utility systems, PQ requires the utility carrier to meet all specifications over a long sample period.
PQ documentation should refer to standard manufacturing procedures and batch records and describe the sampling methodology and testing to use.
This is validated
General
All process steps, production equipment, systems and the environment, directly used in the manufacture of products sterile and non-sterile products must be formally validated.
All major packaging materials and processes must be validated. This validation is less complete.
All auxiliary systems that are not directly impact the quality of the product must be qualified through technical documentation of the extent of the system and how it works.
Easy
- Area Design Manufacturing.
- Personnel and material flow, etc.
Process and equipment design
steps of the process and the description of the equipment. ie distribution, formulation, washing of the packaging equipment,
and cleaning. etc.
Systems design Utility
Raw / purified steam, purified water, etc. waste compressed air, air conditioning system, vacuum, power, lighting, cooling water,
Designing computer systems
information system, automated laboratory equipment, manufacture of automated industrial equipment, electronics, etc. files
Cleaning validation (CV)
CV provides documentary evidence that a cleaning procedure is effective in reducing pre-defined maximum tolerable limits, all chemical and microbiological contamination from a piece of equipment or a manufacturing area following the treatment. The way to assess the cleaning efficiency involves sampling cleaned and disinfected surfaces and check the level of product residues, cleaning residues and bacterial contamination.
The CV term should be used to describe the analytical investigation of a procedure or cleaning cycle. The validation protocols must refer to the basic documentation relating to the justification of "worst case" testing when it is offered. It must also explain the development of acceptance criteria, including chemical and microbial specifications, limits of detection and selection of sampling methods.
Method Validation (MV)
MV provides documented evidence that the test methods developed internally are accurate, robust, efficient, reproducible and repeatable. The validation protocols must refer to the basic documentation relating to the justification of determining detection sensitivity limits and method.
Computer Validation
Computer Validation provides documented evidence to ensure systems will still function according to their predetermined specifications and quality attributes, throughout their life cycle. Important aspects of this validation process are the formal design management (through a process of specification); quality system (through a systematic review and analysis), risk (through the identification and evaluation of new and critical feature) and life cycle (through control lasting change).
When the equipment is controlled by embedded computer systems, computer validation elements can be performed as part of the equipment and IQ OQ protocols.
...................................................................................................................................
Process validation concept for the pharmaceutical industry
Validation concept
In accordance with GFD validation definition is "Establish documented evidence that provides a high degree of assurance that a specific process will always produce a product that meets its predetermined specifications and quality attributes."
Appropriate and comprehensive documentation is recognized as being essential for validating data. Standard Operating Procedures (SOPs), manufacturing formulas, detailed batch documentation, change control systems, survey reporting systems, analytical documentation, development reports, protocol validation, and reports are an integral part of the validation philosophy. The validation documentation is a source of information for the ongoing operation of the installation and is a resource that is used in the subsequent development process or modification activities.
All validation activities will include a level impact assessment to ensure that the systems, services and products directly influenced by the testing have been identified.
A revalidation program must be implemented based on routine equipment revalidation requirements and on the change control policy.
Types of Validation
Prospective validation
Establishing documented evidence that a piece of equipment / process or system will do what it is supposed to do, based on a series of pre-planned scientific tests as defined in the validation plan.
Simultaneous validation
When using an existing method can be localized to be in a state of control by applying tests on samples at strategic points through a process, and at the end of the process. All data are collected at the same time as the implementation of the procedure until the available information is sufficient to demonstrate reproducibility of the process.
Retrospective validation
Establishing documented evidence that a process is doing what it is supposed to do, based on the review and analysis of historical data.
Qualification Design (DQ)
The purpose of the DQ is fulfilled during design and commissioning by a number of mechanisms including:
- Generation of specification of user requirements
- Verification that the design meets the relevant specifications of user requirements.
Assessment Provider / Audits -
- The challenge of designing by GMP exam audits
- Evaluation of the impact of quality products
- Specification of hardware vendor validation documentation requirements
- Agreement with suppliers on performance objectives
- Factory acceptance testing (FAT), Site Acceptance Test (SAT) and commissioning procedures
- Definition of the construction and installation documentation to assist in qualification of the installation (IQ).
Installation Qualification (IQ)
IQ provides documented evidence that this equipment or system has been developed, supplied and installed in accordance with the technical drawings, supplier's advice and In-house requirements. In addition, the IQ ensures that the file of the main characteristics of the equipment or system, as installed, is available and that it is supported by adequate documentation sufficient to allow satisfactory operation of control. maintenance and change to implement.
Operational Qualification (OQ)
OQ provides documented evidence that the equipment operates as intended throughout the specific, operational design or acceptance limits of the approved equipment, if applicable. In cases where the process steps are tested, an appropriate placebo lot will be used to demonstrate the functionality of the equipment.
All new equipment must be fully commissioned before the start OQ to ensure that, at a minimum, the equipment is safe to operate, all mechanical assembly and pre-qualification checks have been performed, that the equipment is fully functional and that the documentation is complete.
Performance Qualification (PQ)
The purpose of PQ is to provide documented evidence that the equipment can still achieve and maintain its performance specifications over an extended period of operation at a defined operating point to produce a product of predetermined quality. The performance specifications will reference process parameters, in-process and product specifications. PQ requires three batches of products to meet all of the acceptance criteria for in-process and on-product. For utility systems, PQ requires utility support to meet all specifications during an extended sampling period.
The PQ documentation must refer to standard manufacturing processes and batch records and describe the sampling and testing methodology to be used.
What is validated
General
All process steps, production equipment, systems and the environment directly used for the production of sterile and non-sterile products must be formally validated.
All major packaging material and processes must be validated. This validation is less complete.
All ancillary systems that do not directly relate to the impact on the quality of the product must be qualified by means of technical documentation of the extent of the system and how it works.
Ease
- Area Design Manufacturing.
- Staff and material flows, etc.
Equipment design process and
The stages of the process and the description of the equipment. ie distribution, formulation, washing of packaging equipment,
and cleaning. etc.
System Design Utility
Raw / purified steam, purified water, etc. Compressed air waste, air conditioning system, vacuum, power supply, lighting, cooling water,
Computerized Systems Design
Information system, automated laboratory equipment, automated equipment manufacturing, electronic records etc.
Cleaning validation (CV)
CV provides documented evidence that a cleaning procedure is effective in reducing the pre-defined maximum allowable limits, all chemicals and microbiological contamination of a piece of equipment or manufacturing area after treatment. The means to evaluate cleaning efficiency involves sampling cleaned and sanitized surfaces, and checking the level of residues of cleaning products and residues of bacterial contamination.
The term CV is used to describe the analytical study of a cleaning or cycle procedure. Validation protocols should refer to the basic documentation of the "worst case" justification for testing when it is proposed. It should also explain the development of acceptance criteria, including chemical and microbial specifications, detection limits and selection of sampling methods.
Validation of the method (MV)
MV provides documented evidence that internally developed test methods are accurate, robust, efficient, reproducible and repeatable. Validation protocols should refer to the basic documentation of the rationale for determining sensitivity limits for the detection and method.
Computer validation
Computer validation provides documented evidence to ensure systems will always operate according to their predetermined specifications and quality attributes, throughout their life cycle. Important aspects of this validation approach are the formal management of the design (through a specification process), the quality system (through systematic review and testing); risk (through identification and assessment of novelty and critical functionality) and life cycle (through control of lasting changes).
When the equipment is controlled by integrated computer systems, computer validation elements can be performed as part of the IQ OQ equipment and protocols ....
In accordance with GFD validation definition is "Establish documented evidence that provides a high degree of assurance that a specific process will always produce a product that meets its predetermined specifications and quality attributes."
Appropriate and comprehensive documentation is recognized as being essential for validating data. Standard Operating Procedures (SOPs), manufacturing formulas, detailed batch documentation, change control systems, survey reporting systems, analytical documentation, development reports, protocol validation, and reports are an integral part of the validation philosophy. The validation documentation is a source of information for the ongoing operation of the installation and is a resource that is used in the subsequent development process or modification activities.
All validation activities will include a level impact assessment to ensure that the systems, services and products directly influenced by the testing have been identified.
A revalidation program must be implemented based on routine equipment revalidation requirements and on the change control policy.
Types of Validation
Prospective validation
Establishing documented evidence that a piece of equipment / process or system will do what it is supposed to do, based on a series of pre-planned scientific tests as defined in the validation plan.
Simultaneous validation
When using an existing method can be localized to be in a state of control by applying tests on samples at strategic points through a process, and at the end of the process. All data are collected at the same time as the implementation of the procedure until the available information is sufficient to demonstrate reproducibility of the process.
Retrospective validation
Establishing documented evidence that a process is doing what it is supposed to do, based on the review and analysis of historical data.
Qualification Design (DQ)
The purpose of the DQ is fulfilled during design and commissioning by a number of mechanisms including:
- Generation of specification of user requirements
- Verification that the design meets the relevant specifications of user requirements.
Assessment Provider / Audits -
- The challenge of designing by GMP exam audits
- Evaluation of the impact of quality products
- Specification of hardware vendor validation documentation requirements
- Agreement with suppliers on performance objectives
- Factory acceptance testing (FAT), Site Acceptance Test (SAT) and commissioning procedures
- Definition of the construction and installation documentation to assist in qualification of the installation (IQ).
Installation Qualification (IQ)
IQ provides documented evidence that this equipment or system has been developed, supplied and installed in accordance with the technical drawings, supplier's advice and In-house requirements. In addition, the IQ ensures that the file of the main characteristics of the equipment or system, as installed, is available and that it is supported by adequate documentation sufficient to allow satisfactory operation of control. maintenance and change to implement.
Operational Qualification (OQ)
OQ provides documented evidence that the equipment operates as intended throughout the specific, operational design or acceptance limits of the approved equipment, if applicable. In cases where the process steps are tested, an appropriate placebo lot will be used to demonstrate the functionality of the equipment.
All new equipment must be fully commissioned before the start OQ to ensure that, at a minimum, the equipment is safe to operate, all mechanical assembly and pre-qualification checks have been performed, that the equipment is fully functional and that the documentation is complete.
Performance Qualification (PQ)
The purpose of PQ is to provide documented evidence that the equipment can still achieve and maintain its performance specifications over an extended period of operation at a defined operating point to produce a product of predetermined quality. The performance specifications will reference process parameters, in-process and product specifications. PQ requires three batches of products to meet all of the acceptance criteria for in-process and on-product. For utility systems, PQ requires utility support to meet all specifications during an extended sampling period.
The PQ documentation must refer to standard manufacturing processes and batch records and describe the sampling and testing methodology to be used.
What is validated
General
All process steps, production equipment, systems and the environment directly used for the production of sterile and non-sterile products must be formally validated.
All major packaging material and processes must be validated. This validation is less complete.
All ancillary systems that do not directly relate to the impact on the quality of the product must be qualified by means of technical documentation of the extent of the system and how it works.
Ease
- Area Design Manufacturing.
- Staff and material flows, etc.
Equipment design process and
The stages of the process and the description of the equipment. ie distribution, formulation, washing of packaging equipment,
and cleaning. etc.
System Design Utility
Raw / purified steam, purified water, etc. Compressed air waste, air conditioning system, vacuum, power supply, lighting, cooling water,
Computerized Systems Design
Information system, automated laboratory equipment, automated equipment manufacturing, electronic records etc.
Cleaning validation (CV)
CV provides documented evidence that a cleaning procedure is effective in reducing the pre-defined maximum allowable limits, all chemicals and microbiological contamination of a piece of equipment or manufacturing area after treatment. The means to evaluate cleaning efficiency involves sampling cleaned and sanitized surfaces, and checking the level of residues of cleaning products and residues of bacterial contamination.
The term CV is used to describe the analytical study of a cleaning or cycle procedure. Validation protocols should refer to the basic documentation of the "worst case" justification for testing when it is proposed. It should also explain the development of acceptance criteria, including chemical and microbial specifications, detection limits and selection of sampling methods.
Validation of the method (MV)
MV provides documented evidence that internally developed test methods are accurate, robust, efficient, reproducible and repeatable. Validation protocols should refer to the basic documentation of the rationale for determining sensitivity limits for the detection and method.
Computer validation
Computer validation provides documented evidence to ensure systems will always operate according to their predetermined specifications and quality attributes, throughout their life cycle. Important aspects of this validation approach are the formal management of the design (through a specification process), the quality system (through systematic review and testing); risk (through identification and assessment of novelty and critical functionality) and life cycle (through control of lasting changes).
When the equipment is controlled by integrated computer systems, computer validation elements can be performed as part of the IQ OQ equipment and protocols ....
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