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Validation Procedures in Pharmaceutical Industry - An Overview

Validation is the documented act of proving that any procedure, process, equipment, material, activity or system actually leads to the expected result. Method validation is the process of establishing the performance characteristics and limitations of a method and the identification of the influences which may change these characteristics and to what extent.

Types of Validation

Prospective validation represents all the activities performed before the distribution of new products to ensure compliance with the initial(legislative/proposed) conditions by the product characteristics.

Concurrent validation is issued for establishing documented evidence during actual imputation of the process to show that the process is in a state of control.

Retrospective process validation is based on a review of historical manufacturing and testing data, and the analysis of accumulated results from past production to assess the consistency of a process. It is assumed that the composition, procedures and equipment remained unchanged. During retrospective validation, results of in-process and final control tests are evaluated.

Revalidation is an exploratory review of the current performance of the validation effect to confirm the validated status of the facilities, systems, equipments, manufacturing processes and software.

Examples of Pharmaceutical Validation Guidelines

1. Process Validation Guideline ICH - Download Here

2. US FDA guidelines for equipment qualification - Download Here

3. FDA Process validation guidance - Download Here

4. WHO guidelines for process validation - Download Here

5. EMA Process validation - Download Here

6. PICS Guidelines for Process Validation - Download Here

7. IPA Process Validation Guidelines - Download Here
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