As a gmp-experts core competence, we support You to sovereignly stand authority inspections (EU, US FDA, SwissMedic, ANVISA / Brasil, PMDA / Japan) and customer audits. As a preparative step we can identify weak points in Your GMP compliance through mock audits. Together with You we also review and assess reports from past inspections. We will stay available to You during the subsequent preparation for the next audit or inspection and will help You to get all Your questions answered.
Our support services concerning the revision of GMP systems are extensive and have stood the test of reality many times. Where requested, we will sensitize Your personnel for important details and traps – through inspection training. This promotes confidence and through that professional behavior during the audit or inspection. In some situations, inspection escorting from our side can be expedient. It has been our experience that this is received positively by authority representatives.
Our services to You:
- Mock auditing for identification of potential GMP compliance deficits and weak points
- Support in mending weak points and correction of deficiencies
- Revision of quality assurance processes (e.g. CAPA, PQR, deviation management)
- Preparation or moderating of risk analyses
- Where requested, communication to involve authorities in a GMP upgrade process
- Practical in-house inspection training during preparation for inspections
- Inspection escorting and support in Front- and Back-Office