Validation 1
This document was uploaded by user and they confirmed that they have the permission to share it. If you are author or own the copyright of this book, please report to us by using this DMCA report form. Report DMCA
Overview
Download & View Validation 1 as PDF for free.
More details
- Words: 490
- Pages: 17
VALIDATION
DEFINITION Validation is defined as the establishing of documented evidence which provides a high degree of assurance that a planned process will consistently perform according to the intended specified outcomes .
Validation studies Analytical tests (pH of the lot for parenterals ) Equipment (temp ,pressure of molding machines) Facility systems such as air, water, steam For processes such as Cleaning Sterilization( sterilizer time and temperature data) Sterile filling Lyophilization
PROCESS VALIDATION DEFINITIONS
INSTALLATION QUALIFICATION Establishing confidence that process equipment and ancillary systems are capable of consistently operation within established limits and tolerances.
PROCESS PERFORMANCE QUALIFICATION
Establishing confidence that the process is effective and reproducible
PRODUCT PERFORMANCE QUALIFICATION
Establishing confidence through appropriate testing that the finished product produced by a specified process meets all release requirements for functionality and safety (mainly for medical devices)
PROSPECTIVE VALIDATION
Validation conducted prior to the distribution of either a new product or product made under a revised manufacturing process. Where the revisions may affect the product’s characteristics.
RETROSPECTIVE VALIDATION
Validation of a process for a product already in distribution based upon accumulated production,testing and control data.
VALIDATION PROTOCOL
A written plan stating how validation will be conducted,including test parameters,product characteristics ,production ,equipment and decision points on what constitutes acceptable test results.
VALIDATION PROTOCOL Specifies Procedures Tests to be conducted Data to be collected
Purpose for which data is collected Should be clear Reflect facts Data to be collected carefully and accurately
contd Protocol should specify Sufficient number of replicate process runs Demonstrate reproducibility Provide an accurate measure of variability among successive runs
Key process variables to be monitored and documented
ELEMENTS OF PROCESS VALIDATION PROSPECTIVE VALIDATIION
Equipment and process
Process
Performance qualification
Product
Installation qualification
Performance qualification
Documentation
Equipment : IQ Examination of equipment design Determination of calibration Mainatanance Adjustment requirements Identify critical equipment features Repeat tests and challenges
contd IQ should include Review of pertinent maintanance procedures Repair parts lists Calibration methods
Objective : to assure that all repairs does not affect the characters of the material processed
PROCESS :PERFORMANCE QUALIFICATION Purpose:
Provide rigorous testing to demonstrate effectiveness and reproducibility of a process
Process specification are established through lab studies or trials Process should be defined and described
DOCUMENTATION Validation program documented Data from EQ,PQ and product package testing For routine production Process details(time, temperature ,equipment used) Record any changes which have occurred
ELEMENTS OF PROCESS VALIDATION RETROSPECTIVE PROCESS VALIDATION
Insufficient premarket process validation
VALIDATION PHASE GOALS Technical transfer of deliverables from the Development phase Plans for process & method validation Documented evidence of assurance that the facility is capable of manufacturing a clinical product Elements Validation Timeline Validation Plan
VALIDATION PHASE GOALS Documentation Training Test Methods Equipment/Supplier qualification Risk Management Budget Review Validation execution & approval
DEFINITION Validation is defined as the establishing of documented evidence which provides a high degree of assurance that a planned process will consistently perform according to the intended specified outcomes .
Validation studies Analytical tests (pH of the lot for parenterals ) Equipment (temp ,pressure of molding machines) Facility systems such as air, water, steam For processes such as Cleaning Sterilization( sterilizer time and temperature data) Sterile filling Lyophilization
PROCESS VALIDATION DEFINITIONS
INSTALLATION QUALIFICATION Establishing confidence that process equipment and ancillary systems are capable of consistently operation within established limits and tolerances.
PROCESS PERFORMANCE QUALIFICATION
Establishing confidence that the process is effective and reproducible
PRODUCT PERFORMANCE QUALIFICATION
Establishing confidence through appropriate testing that the finished product produced by a specified process meets all release requirements for functionality and safety (mainly for medical devices)
PROSPECTIVE VALIDATION
Validation conducted prior to the distribution of either a new product or product made under a revised manufacturing process. Where the revisions may affect the product’s characteristics.
RETROSPECTIVE VALIDATION
Validation of a process for a product already in distribution based upon accumulated production,testing and control data.
VALIDATION PROTOCOL
A written plan stating how validation will be conducted,including test parameters,product characteristics ,production ,equipment and decision points on what constitutes acceptable test results.
VALIDATION PROTOCOL Specifies Procedures Tests to be conducted Data to be collected
Purpose for which data is collected Should be clear Reflect facts Data to be collected carefully and accurately
contd Protocol should specify Sufficient number of replicate process runs Demonstrate reproducibility Provide an accurate measure of variability among successive runs
Key process variables to be monitored and documented
ELEMENTS OF PROCESS VALIDATION PROSPECTIVE VALIDATIION
Equipment and process
Process
Performance qualification
Product
Installation qualification
Performance qualification
Documentation
Equipment : IQ Examination of equipment design Determination of calibration Mainatanance Adjustment requirements Identify critical equipment features Repeat tests and challenges
contd IQ should include Review of pertinent maintanance procedures Repair parts lists Calibration methods
Objective : to assure that all repairs does not affect the characters of the material processed
PROCESS :PERFORMANCE QUALIFICATION Purpose:
Provide rigorous testing to demonstrate effectiveness and reproducibility of a process
Process specification are established through lab studies or trials Process should be defined and described
DOCUMENTATION Validation program documented Data from EQ,PQ and product package testing For routine production Process details(time, temperature ,equipment used) Record any changes which have occurred
ELEMENTS OF PROCESS VALIDATION RETROSPECTIVE PROCESS VALIDATION
Insufficient premarket process validation
VALIDATION PHASE GOALS Technical transfer of deliverables from the Development phase Plans for process & method validation Documented evidence of assurance that the facility is capable of manufacturing a clinical product Elements Validation Timeline Validation Plan
VALIDATION PHASE GOALS Documentation Training Test Methods Equipment/Supplier qualification Risk Management Budget Review Validation execution & approval
Related Documents
Validation 1
June 2020 5
Validation 1
November 2019 19
Validation
June 2020 20
Validation
June 2020 24
Validation Statement - 1
November 2019 1