Validation Part -II

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Dear Bloggers, I am back again, to you all with my second blog for this month. After going through basics of validation in my first blog (validation Part-I), now I am going to share about: - Types of Validation - Phases of Validation - Equipment Validation - Strategy for Validation -Approaches to Validation Types of Validation Prospective Validation: This Validation is carried out on the batches in the development process. During this exercise whenever any critical situation is found out, then it is investigated and an overall assessment is done after carrying out the trial batches. This type of Validation is very good since the possible risks can be avoided at the later production stage. Concurrent Validation: This validation is carries out on normal production batches. The first three production or pilot batches are studied exhaustively. Retrospective Validation: It is based on the past experience and knowledge gained that the composition procedures and equipment remain unchanged; the results of in-process and final control tests are then evaluated based on this knowledge and experience. Retrospective Validation is never carried out on the new processes or products. Phases of Validation Phase 1 : Pre-Validation Phase Phase 2 : Process Validation Phase Phase 3 : Validation Maintenance Phase Equipment Validation The Validation package must provide the necessary information and test procedures required to provide that the system and process meet specified requirements (1) It comprises of the following Qualifications * Design Qualification (DQ) * Installation Qualification (IQ) * Operational Qualification (OQ) * Performance Qualification (PQ) Strategy for Validation (2) 1) Process Definition activities are identified which define the exact process to be validated. 2) The analytical methods which will be used to define the process need to be qualified and validated. 3) The quality of the starting materials and raw materials should be defined, and the capability of the operators, facility, equipment, and utilities should be examined using historical data, deviations, and planned experiments during clinical batches 4) Finally, the strategy for product specific cleaning has to be designed Approaches of Validation (3) There are two basic approaches to the validation of the process, first is the experimental approach and other is the approach based on the analysis of historical data. The experimental approach which is applicable to both prospective and concurrent validation, may involove - extensive product testing - simulation process trials - challenges/wprst case trials, and - control of process parameters (1) Guideline on General principles of Process Validation. Washington DC: Center for Drug Evaluation and Research,US Food and Drug Administration, May 1987, page.9. (2) accessed on 18 March 2011. (3) Nash RA. Process Validation of a 17-year reterospective study of solif dosage forms. Drug Dev Ind Pharm 1966;22 (1):25-34.

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Author: Shikha Chauhan

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