Audit is an increasing requirement being placed on the pharmaceutical industry for those in manufacturing and distribution of medicinal products. Traditionally the audit requirement has extended to Contract Manufacturing Organisations and Contract Laboratories, but the obligations are extending to Distributors of the Finished Product and Manufacturers and Distributors of Active Pharmaceutical Ingredients (APIs). In some cases, even excipients carry the requirement for auditing. It is also common for the audit function to be applied to emerging areas of Regulatory Concern such as Marketing Authorisation Holders, Packaging Suppliers, etc.
Our experienced group of QPs and Auditors are uniquely placed to meet your audit needs with focus on the following deliverables;
- Quality expertise
- Regulatory expertise
- Risk-based focus
- Technical expertise