Audit - 14

Audit Manual 14 - Auditing Microbiology and Sterility 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 14 - Auditing Microbiology and Sterility Testing Laboratory

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The purpose of this training module is to provide information on what to include in a microbiological and sterility testing laboratory audit. Microbiological testing is used to release products, determine if production environments are satisfactory and determine if results of in-process testing are satisfactory.

It is important to understand how the microbiological laboratory functions. When auditing the lab, review the current organization chart. Determine what tests the lab performs. Determine the distribution of personnel across shifts.

Discuss with the lab manager or responsible person any corrective actions from previous audits. Determine the status of these corrective actions and if they were corrected within the agreed time period.

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