Pharmaceutical, biotechnological, and medical device manufacturers are subject to inspections by various authorities, including the regulatory bodies of the country where manufacturing is carried out and the regulators of the country in which the product is sold. These inspections are performed prior to product approval at routine intervals and in some cases, “for cause”. Inspections may be system-based and cover general GMP compliance or may be product-oriented.
To prepare for inspections, it is useful to have an external organization perform a mock inspection. A mock inspection simulates an actual inspection and the inspection report is structured in the same way as an inspection report from a regulatory agency.
Benefits of mock inspections, or pre-approval readiness reviews include:
- Enabling your inspection team to ‘practice’ the inspection interview process
- Guidance on addressing questions in advance of a real inspection
Our experienced staff includes former FDA employees with extensive auditing experience. Pre-approval Inspection Readiness Reviews are conducted to help your organization prepare for a pre-approval inspection.
If you would like more information, get in contact with us directly here.