There may be a number of reasons why an independent cGMP audit may be required; either before or during a major refurbishment, or simply to address ongoing concerns. It may be to examine the effectiveness of the company’s entire quality system, or it may concentrate on the effectiveness of an individual department within a site. eg Engineering or Production. The outcome of such an audit is usually the production of an action plan for local management to implement.
Aker Kvaerner maintain close contact with the European and US Regulatory Authorities, and have the capability and experience needed to perform independent cGMP audits for the Pharmaceutical industry.
Through our involvement in the generation of the ISPE baseline guide on Commissioning and Qualification, Gap Analysis has been developed into a specialisation by Aker Kvaerner. This form of audit assesses the completeness of the company’s quality system and audit trails. It normally also includes Impact Analysis which, by defining the product critical items, enables the audit team to focus on issues which affect product quality.
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