GDP Audits of API

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Since the publication of guidelines of transporteNovember 2013 on Good Distribution Practices and March 2015 on Good Distribution Practices of active substances for human use medicinal products, the assessment of all providers within distribution has become more important.

This guideline applies equally to pharmaceutical companies in GMP environment as well as MAH, distributors, etc…

The need to assess/audit Distributors, Logistic Operators, etc… is a requirement at all industry steps.

Execution of audits to MAH, Distributors, shippers, Logistics Operators, distribution Centers – Warehouses according to:

  • Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (Text with EEA relevance) (2013/C343/01)
  • Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use (Text with EEA relevance) 
(2015/C 95/01)

 

Benefits
  • Audinnova has expert auditors in audits related with GDPs, in both finished product and APIs.
  • Our auditors have a broad experience and knowledge in distribution, transport and in all links of the distribution supply chain.
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