Cleaning Method Validation of Solid Dosage form

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The objective of Cleaning Validation Master plan ofequipment, utensils, components and areas is · To establish sufficient documented evidence toassure that, cleaning procedures can repeatedly and reproducibly remove residueof the subjected product-within established acceptance limit. The acceptancelimit is maximum allowable quantity of product residue, which does not affectquality and safety of the subsequent product to be manufactured, by using sameequipment and facility. · To establish acceptable time limit for storageof cleaned equipment, utensils and components after cleaning (Cleaned EquipmentHold Time Study). Equipment are not expected to be free from all microorganisms,particularly when the final stage in cleaning does not involve final rinsing withsterile water for injection. The objective shall be to demonstrate that thereis no microbial proliferation in equipments during storage. Themain purpose of cleaning validation master plan is to set up guideline toestablish cleaning, sampling, testing procedure and residue limits that arepractical, achievable, and verifiable to assure safety.

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