GMP and ISO compliance audits

Valicare conducts your GMP audit for your system evaluation - from the internal departments to the customer to the 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 reviews the GMP and/or ISO compliance of your systems (based on EN ISO 19011). We analyze the quality and GMP compliance of your products, processes, and documentation system.

We work in the pharmaceutical, medical device, and biotechnology industries and especially with manufacturers of advanced therapy medicinal products (ATMPs), such as gene therapies, cell therapies and biotechnologically processed tissue products. Our expert audit team covers the entire range of the respective manufacturing processes. We plan and implement your and your customer's approach or perform the service according to our own established and GMP-compliant procedure.

In addition to the above-mentioned guidelines, Valicare perform also audits at blood and tissue banks. The regulations 2002/98/EU, 2004/32/EU, 2004/33/EU and 2006/17/EU are applied here to ensure the quality of the starting materials for cell and gene therapies. For further details regarding auditing blood banks, please see our one-pager at the bottom of this page.

If you are in the process of preparing for an internal, external, or upcoming regulatory inspection, our permanently employed and experienced auditors will support you with their full commitment and professional expertise.

Our portfolio includes pharmaceuticals, active pharmaceutical ingredients, biologicals, medical devices, intermediate products as well as excipients. We also carry out audits for advanced therapy medicinal products (ATMPs), including the supply of starting materials such as blood products and tissues.

This is why you should work with us:

Certified auditors who know what is important for inspections

Unbiased, external view of GMP compliance

GMP consultants who know regulations from practical experience

Always up to date with the latest GMP requirements

We conduct the following compliance audits:

Good Manufacturing Practices (GMP) Compliance Audit
Good Distribution Practices (GDP)
Good Laboratory Practices (GLP)
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 audit services comprise:

Preparation, support, and execution of internal and external audits
Preparation and support of inspections by authorities
"Mock" inspections, e.g., as a preparatory measure before authority inspections
Staff Training in preparation for audits and inspections

The audit or analysis report accurately and factually documents all deviations found, which are subsequently discussed with you in detail.

We review or define required "Corrective and Preventive Action" (CAPA) measures and ensure their implementation by follow-up audits.

GMP Audits and Remote GMP Services Download

Brochure: Audits & Inspections

One Pager: Auditing of Blood Banks

One-Pager: Remote GMP Services

Free first consultation now!

Dr. Ellen Sons-Brinkmann
Phone: +49 69 153 293 709

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News

Stay up to date with the latest developments and news from the world of Good Manufacturing Practice (GMP), Advanced Therapy Medicinal Products (ATMP) and Valicare. Our overview provides you with valuable insights to always keep you informed and competitive.

GMP Compliance

Professional GMP compliance ensures the quality of drugs and active ingredients.

Cell and Gene Therapy

ATMPs offer new, promising therapeutic approaches for diseases that were previously considered incurable. However, the regulatory requirements are challenging.

Brochures

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Our Company

Valicare is an ISO 9001-certified service company and operates in the area of qualification and validation of technical equipment and processes.