Auditing and assistance for compliance |
We are able to perform a wide range of audits and inspections at the client’s site. Our audit teams comprise of experienced chemists, former auditors, engineers, analytical and/or quality assurance experts who have had practical experience in the industry and are aware of the latest developments, trends and norms. They can check your facility design and construction, manufacturing processes, analytical methodology, validation procedures, stability testing facilities and all your equipment for compliance with regulations, guidelines and GMP. Upon compilation of a detailed report of the findings, suggestions for changes, modifications and corrective action may be made. Working with your technical staff in critically analysing the findings and benchmarking your practices against the best in the industry, our teams can identify particular problem areas and devise solutions. Audits can generally be conducted for the purpose of: • ISO 9001:2000 compliance check • WHO GMP or regulatory pre-inspection • Pre-customer inspection • Equipment and Process checks for GMP compliance and maintenance We can also help you develop and implement self inspection or internal audit programmes based on internationally recognized standards and published WHO GMP guidelines. |
