483s During cGMP Inspection of Sterile Manufacturing Site

• Lack of time limits between product manufacture and filling
• Lack of filter validation for microbial challenge and extractables

• Lack of SOP for how sterility test samples are obtained
• Failure to collect sufficient number of samples to evaluate for particulate matter based on valid statistical plan
• Failure to design and maintain WFI system in certain buildings
• Failure to establish sufficiently detailed and validated instructions for batch reprocessing
• Failure to validate the environment where filling machines located
• Levels of viable and nonviable particulates observed during production cannot be related to media fills or other qualification studies

To be continued…