Inspection of analytical test facilities

The following is a summary of some of the typical areas that an inspector would be required to scrutinise for both drug products and APIs. 

Pre-approval inspections are designed to confirm that the data submitted in an application is authentic and accurate and that the procedures used in the application were actually used to produce the data contained in the application. Since not all data can be included in a submission, the inspection must 

Laboratory records and logs represent a vital source of information that allows a complete overview of the technical ability of the staff and of the overall QC procedures. Laboratory data review would include  

The review of microbiological data regarding topical and parenteral manufacture would typically include  

Laboratory standard solutions must be ascertained as being suitable for use in that they are  

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