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Good manufacturing and distribution practices for pharmaceutical excipients
EXCiPACT, Good manufacturing and distribution practices of pharmaceutical excipients

Good manufacturing and distribution practices for pharmaceutical excipients

Quality and safety assurance in pharmaceutical excipients

Excipact ™ is a voluntary certification scheme aimed at companies that manufacture or distribute pharmaceutical excipients with a global outreach.

This certification scheme reinforces the safety of medication through a quality management system, whilst minimising quality assessment costs within the supply chain of excipients.

Good manufacturing practice (GMP) and good distribution practices (GDP) constitute the practical development of the concept of quality assurance and they are based on solid scientific criteria and risk assessments.

Benefits obtained:

  • Guarantee that the organisation complies with Good Manufacturing and/or Distribution Practices of excipients according to the Excipact references.
  • Cost savings as the audit load by medication manufacturers is reduced.
  • Improves the levels of management, planning, organisation and control.
  • Ensures maximum quality and safety of the excipients.
  • Access to new markets through an internationally renowned certification scheme.

Applicable to manufacturers and distributors of pharmaceutical excipients.

Fácil integración con cualquier sistema de gestión por procesos, como ISO 9001.

Once the audit process has been successfully completed your organisation obtains:

  • A complete audit report in English so that the certified organisation can show it to its customers.
  • Certificate of compliance with the Excipact references of Good Manufacturing Practices (GMP) and/or Distribution of pharmaceutical excipients.
  • Inclusion of the organisation on the list of available certified companies on the Excipact website.

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BCN Trasvases, S.L. and Croda Iberica SA were the first companies to be certified by AENOR in this scheme.