Internal and supplier auditing for life science companies

Auditing services

The bedrock of Good Manufacturing Practice (GMP), Good Distribution Practice GDP), and Good Laboratory Practice (GLP) is control, not trust.

Regular internal and supplier audits are an essential part of the life cycle of a medicinal product, a medical device or in vitro diagnostics. A well-executed audit will help to ensure regulatory compliance and mitigate quality risks. It may also protect your investments in suppliers and products.

Our expert auditors have extensive experience of working in the life-science industry and can support you with an audit, which has your process in focus, to identify potential gaps versus applicable regulations that may also be critical to the success of your project.

 

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Managing successful GMP, GDP, and GLP audits

Our experienced specialists provide independent, objective assessments to help you succeed in your auditing activities.

Internal audits or Self-inspections: Making sure that your own quality system is efficient and compliant is key regardless of whether you are a wholesale distributor, Marketing Authorisation Holder, manufacturer or development company. We like to look at internal audits as your possibility to identify potential gaps versus regulations, but also to identify opportunities for improvements and streamlining.

Supplier qualification: Audits of suppliers are not only a regulatory requirement, but it also helps ensure that your assets are secured and build a well-functioning relationship with your supplier. A well-executed audit is a good investment for both you and the auditee. 

Auditor: As an auditor you need to know the applicable regulations, be objective and experienced with the audit process. Another critical asset that we value with our team of auditors is to have extensive practical experience from the applicable area. This allows you to make an overall impact analysis of the quality processes and to make risk-based assessments of findings.

Why use our team for auditing support?

We can support you with audits of your suppliers or self-inspections, as well as offer advice in the CAPA process after an audit or inspection. Our experienced consultants can help with planning, conducting and reporting of audits for medicinal products, medical devices and in vitro diagnostics.

We have experienced auditors in the following areas:

  • Good Manufacturing Practice (GMP), for example:
    • Final product manufacturers of sterile and non-sterile products, biologics and Advanced Therapy Medicinal Products (ATMPs).
    • Manufacturers of API and Regulatory starting material
    • Packaging operations
    • Analytical laboratories
  • Good Distribution Practice (GDP), for example:
    • Warehousing and distribution
    • Wholesale distributors
    • Transport companies
  • Good Laboratory Practice (GLP), for example
    • Contract research organizations (CROs), analytical laboratories
    • Non-clinical safety studies (Tox studies)
  • Medical Device and IVD: LINK TO MEDICAL DEVICE
  • Internal audits within GMP, GDP, GLP, ISO 13485, MDSAP, FDA

 

More quality assurance services

Acting Qualified Person (QP)
Commercial production support and advice
GMP responsibilities for MA holders
Quality assurance and GMP compliance
Quality control and batch evaluation
Technology transfer support and advice

Your contact person
Portrait of Nelly Fransen Arex Advisor

Nelly Fransén

www.arexadvisor.com

Arex Advisor AB

  • Sveavägen 9,
  • 111 57 Stockholm
  • Sweden

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Staffan Thunell

Founding partner

BSc Economics and BA

Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from posit­ions as Founder, Chair­man, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.