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GMP Audits

PharmAssess™ GMP Audits

PharmAssess™ is a GMP audit service that has been created by Rephine to help pharmaceutical manufacturers meet their regulatory requirements for GMP audits. With the introduction of 2004/27/EC in October 2005, the pharmaceutical industry is now required "to use as starting materials only active substances, which have been manufactured in accordance with the detailed guidelines on GMP for starting materials." (ICH Q7).

ICH Q7 Rules and guidance for Pharmaceutical Manufacturers and Distributors (orange guide) 2007 »

Manufacturers are required to carry out GMP audits of suppliers themselves or have audits undertaken on their behalf by appropriately qualified and experienced auditors.

PharmAssess™ is a third party GMP audit service that benefits the supplier by reducing the number of audits carried out at their site and is more economical for manufacturers than undertaking audits themselves.

The PharmAssess™ GMP Audit Service

  • Is a fully independent third party audit service
  • Produces audit reports that are detailed and comprehensive
  • Provides audit reports that have been accepted by QPs and Regulatory Authorities in 30 countries
  • Makes a statement of compliance with acknowledged GMP auditing quality standards
  • Only uses auditors who are highly experienced and qualified
  • Audit reports are updated with CAPA progress
  • Carries out re-audits every 2-3 years

The PharmAssess™ Audit Process

  1. Supplier Engagement and Confidentiality Agreements are signed
  2. Scope and standards of the audit are agreed
  3. Audit is carried out
  4. Interim report produced
  5. Audit report and remedial plan finalised
  6. PharmAssess™ audit report available to purchasers
  7. Update obtained and eventual closure

The Financial Incentive

  • PharmAssess™ GMP audits are carried out at NO CHARGE to the supplier and are undertaken by PharmAssess auditors
  • Repetitive auditing of suppliers is reduced and cost savings are made
  • Reduced disruption to manufacturing as a result of fewer audits
  • The cost of a PharmAssess™ audit report to each purchaser is a fraction of typical audit costs

Further Information

GMP Audits Reports Available for Purchase

To view the list of available GMP audit reports to purchase, see Pharmassess GMP Audit Reports Available ».

Frequently Asked Questions

If you have any questions relating to the PharmAssess™ API Supplier Audit service please see FAQs.

Please do not hesitate to contact Rephine if you have a question that has not been answered here.