GMP Audits

GMP and ISO compliance Audits

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. 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.

If you are in the process of preparing for an internal, external or an upcoming regulatory inspection, our permanently employed, certified and experienced auditors will support you with their full commitment and professional expertise. Our portfolio includes Advanced Therapy Medicinal Products (ATMPs), pharmaceuticals, active pharmaceutical ingredients, biologicals and medical devices, intermediate products as well as Excipients.

That's why you should choose to work with us:

Certified auditors who know what is important about inspections
Experienced GMP consultants for whom regulations are not just theory
Unbiased, external view of GMP compliance
Always up to date with the latest GMP requirements

Our certified auditors have conducted a large number of successful audits worldwide since 2020, particularly in Europe, Canada and Asia (e.g. India and Taiwan). Benefit from our professionalism and the long-standing GMP audit experiences of our experts and feel comfortable and confident in future audits and inspections.

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Overview of our audits
We conduct these audits:
- Good Manufacturing Practices (GMP) Compliance Audit
- Good Distribution Practices (GDP) Compliance Audit
- Good Laboratory Practices (GLP) Compliance Audit
- Gap Analysis
- Supplier Qualification of equipment suppliers, contract manufacturers, contract laboratories and service providers
- Computer System Validation (CSV)
- Hardware Qualification/Software Validation
- CASY Accreditation
- DIN ISO 9001:2016 Accreditation
Our range of services
Our audit services:
- Preparation, support, implementation of internal and external audits
- Preparation and support of inspections by authorities
- "Mock" inspections, e.g., as a preparatory measure before authority inspections
- Training of employees in preparation for audits and inspections
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.