Supplier audits

Compliance with cGMP, GLP or GCP does not depend solely on the company’s own organization; compliance requirements extend to any critical service provider.

The audit of providers of critical materials or services is an essential activity for their qualification which, in turn, is one of the key milestones of the Pharmaceutical Quality System in an environment that, at the operational level, is increasingly fragmented and globalized.

The audit provides an insight into the level of confidence that can be placed on the quality system of our suppliers and in their compliance with associated regulations, so that it can be ensured that the extended operations of drug manufacturing comply with GxP and that the quality of the drug is not adversely affected by supplier operations.

The services that are generally audited are the following:

GMP Services:

  • Contract manufacturing
  • Active substances (API)
  • Excipients
  • Packaging material

GDP Services:

  • Distribution of medicines and starting materials
  • Storage of medicines and starting materials
  • Transport of medicines and starting materials
  • Logistics operators

GCP Services:

  • CRO

General services:

  • Cloud services, IT, software and integrator
  • Pharmacovigilance
  • Cleaning of work clothes

 

TDV offers customised audit services through the Forum Audits Association, which fosters the sharing of the auditing efforts among different companies, whilst maintaining high quality standards and rigour. More information at www.forumauditorias.org

 

For more information on Supplier  or Internal Audits, please contact:

Eduard Cayón
ecayon@tdvct.com
www.forumauditorias.org

 

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