Audits and Inspections
GMP compliance – regular verification is a key requirement of the GxP rules, regulations and guidelines. Companies are audited by their customers. Official inspections are announced. Thus companies want to make sure they pass the next audit without problems, that documentation and processes are consistently compliant, employees prepared and the list of findings small. In short, audit and inspection readiness is needed. This is where gempex acts as a coach that is familiar with audit and inspection situations, has prepared for them in a variety of ways, provides support and is competent point of contact.
Knowing where You Stand
Whether the offspring is facing the next exam, the vehicle requires an inspection or it’s all about the GMP audit: identifying weak points in advance and addressing them as far as possible is always useful and important. This is where a gap-analysis comes in. It is sensible since it helps identify system weaknesses. Presuming it is performed in a timely manner, it makes it possible to professionally close those gaps. This is a fundamental prerequisite for successful inspections and to pass audits.
When the Strategy is Crucial
Often the GMP system as such is good and satisfactory, but its representation and explanation are lacking so that misunderstandings make the list of findings grow. gempex can help with that as well. For instance by preparing a suitable presentation, designing an audit or inspection program, training key personnel and coordinating the inspection or audit process in detail, including a conceivable tour of the facilities. However, an audit or inspection cannot be planned in advance down to the last detail, since inspectors and auditors also have their say. Nevertheless, good preparation is surely the right way to complete the audit with confidence.
Rehearsing for Real Life and Enjoying Assistance
“Not every emergency needs to be rehearsed, having it occur is enough.” – A nice saying that does not always apply. For companies that never experienced an inspection or have a lot riding on the result, a trial run can be very valuable.
A mock inspection conducted in advance by one of the experienced gempex auditors realistically simulates the audit or official inspection. This can reveal final compliance gaps, provides an independent expert assessment and ultimately leads to inspection readiness. Directly in the company on site. It results in a learning effect among the participants and helps them take control. It also verifies the strategy.
When it comes time for the actual inspection or audit, gempex offers the support of competent consultants who are well aware that not they but the subject of the inspection or audit is primarily in demand.
All Done? Follow-up
The audit or inspection resulted in findings? gempex assists with professional follow-up communication in compliance with the requirements. Fast, competent and reliable. Responses to findings, replies to authorities, definition of CAPAs, implementation and verification. Until the audit is passed, the official inspection successfully completed and the findings addressed.
- no fear of audits and inspections
- clear definition of any remaining weaknesses
- optimal preparation and strategy
- professional and competent support in all phases
- guaranteed success once the GMP system is established