无菌液体药品的过程验证.pdf

Process Validation of Sterile Liquid Products By Weerayut Chirarutsami 23/08/2006 1 Process Validation Process validation is establishing documented evidence which demonstrate that the manufacturing process will consistently produce a product meeting its pre- determined specifications and quality Characteristics. New Product == Trial Batch, Development Batch Transferred Product == Products produced at the sending site Revalidation Product == The original product before revalidation 2 Process Validation Type of Process Validation Prospective Conducted prior to market the product Concurrent Based on information generated during actual implementation of the process (each batch will be released separately) Retrospective (Not recommended for sterile product) Based on accumulated historical production, testing and control data Generally requires data from 10-30 batches Use data only from batches made by the same process 3 Validation of Sterile Product Sterile Product : The Products which free of any viable organisms. Sterility : Viable microorganisms are absent. Bioburden : Total number of viable microorganisms on or in pharmaceutical product prior to sterilization. 4 Validation of Sterile Product Terminal Sterilization : Operation whereby the product is sterilized separately by autoclave after filled and packaged using sterilized containers and closu