Audits to verify GMP and ISO compliance
The performance of GMP audits is the basis for system evaluation by the pharmaceutical manufacturers, regardless of whether it is an internal department, a customer or a supplier.
Based on applicable regulations, standards and guidelines (AMWHV, EU-GMP Part I/II, ICH Q7, ICH Q10, PIC/S, USP-NF ˂1078˃, EN ISO 9001, EN ISO 13485), Valicare GmbH reviews the GMP and/or ISO compliance of your systems. We analyze the quality and GMP compliance of your products, processes and documentation system.
We work across industries in the pharmaceutical, medical device, biotechnology industries and especially with manufacturers of advanced therapy medicinal products (ATMP). We cover the entire range of the respective manufacturing processes by our expert audit team.
If you are in the process of preparing for an internal, external or an upcoming regulatory inspection, we will support you with full commitment and professional expertise by our trained and experienced auditors.
As an audit service provider, Valicare GmbH is a competent partner. Our service can plan and implement your and your customer's approach or can perform the service according to Valicare GmbH's established and GMP-compliant procedure.
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Services for Audits and Inspections
Audits to verify GMP and ISO compliance
- Preparation, support, implementation of internal and external audits as qualification audit, routine or "for-cause" audit
- Third-party audits, e.g. as part of the supplier qualification of raw material, intermediate product, active pharmaceutical ingredient and excipient manufacturers as well as equipment vendors, contract manufacturers, contract laboratories and service providers.
- Preparation and support of inspections by authorities
- Carrying out "mock" inspections, e.g. as a preparatory measure before authority inspections
- Follow-up audits
- GAP analysis for compliance testing of existing GMP systems
- Training of employees, e.g. on how to perform a self-inspection
The audit or analysis report documents accurately and factually, all deviations found, which are subsequently discussed with you in detail.
Required "Corrective and Preventive Action" (CAPA) measures are defined or proposed corrective measures are professionally reviewed and their implementation is sustainably ensured by follow-up audits.
Take advantage of our expertise and capacity to gain more confidence in GMP compliance issues and feel comfortable and confident in future audits and inspections.