To ensure compliance with the regulations of the German Medicines and Active Pharmaceutical Ingredients Regulation (AMWHV), including GMP Directive 91/356/EEC, audits and self-inspections must be carried out regularly in accordance with Chapter 9 of Part 1 of the GMP Guide.
With our experts, who have many years of experience in the pharmaceutical industry, we conduct audits – at your company and also at your suppliers and service providers.
Goals of an audit:
- Description of the strengths and weaknesses of a quality assurance system and its daily implementation, with particular emphasis on the activities performed
- Checking whether the measures derived from previous audits and self-inspections have been implemented and were successful.
Conduct of audits and self-inspections
Audits are to be carried out for all departments in which preparations are medically and scientifically processed, developed, manufactured, tested, stored and logistically supported. These include the Medical Science Departments, Pharmacovigilance, Regulatory Affairs, Marketing, Quality Assurance, Production, Quality Control and Sales.
Depending on the business activities of a company, audits can cover one or more departments or even individual focal points and should take place so frequently that all areas or departments are inspected at least once every 2 years. If certain areas prove to be critical, we recommend conducting self-inspections at shorter intervals.
The conclusion of each audit is a report that concretely and precisely describes the status and proposes measures.