Audit - 15

Audit Manual 15 - Auditing an Analytical Quality & Stability Testing Laboratory

Understand what the GMP requirements are for the analytical quality laboratory and stability testing laboratory. Identify which GMP regulations govern the analytical quality laboratory. Use a range of information tools, from the contents of this training i

Audit 15 - Auditing an Analytical Quality & Stability Testing Laboratory

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The purpose of this training module is to provide information on what to include in an audit of an analytical quality laboratory. Since the analytical laboratory performs many sophisticated and complex tests, this training module will contain detailed information about some of the tests that can be performed in a laboratory to increase the auditor’s understanding of the analytical laboratory environment.

An audit of the quality analytical laboratory is important for a number of reasons. Testing is performed to assure that the drug product meets acceptance criteria throughout the drug manufacturing process and its shelf life. Shown below are the types of testing the analytical laboratory performs and the benefits of the testing.

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