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A Review on Cleaning Validation-Regulatory Guidelines for The Pharmaceutical Industry
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Manufacturing of Pharmaceutical products shall demonstrate a control to reproduce consistently the desired quality of product, wherein the control of cross-contamination plays an important role. An effective cleaning shall be in place to provide documented evidence that the cleaning methods employed within a facility consistently controls potential carryover of product (including intermediates and impurities), cleaning agents and extraneous material into subsequent product to a level which is below predetermined levels. Pharmaceutical manufacturers must validate their cleaning process to ensure compliance with cGMP regulations. So it is necessary to validate the cleaning procedures to ensure safety, efficacy, quality of the subsequent batches of drug product and regulatory requirements in Pharmaceutical product manufacture. In this article cleaning validation and cleaning validation program discussed in brief.
Keywords
- FDA expects firms to have written standard operating procedures (SOP) detailing the cleaning process used for various pieces of equipment.
- If firms have a specific cleaning process for cleaning between different batches of the same product and use a different process for cleaning between product changes, FDA expects the written procedures to address these different scenarios.
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