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According to the revised EU legislation 'the holder of a manufacturing
authorization shall at least be obliged to comply with the principles and
guidelines of good manufacturing practice for medicinal products and to use
as starting materials only active substances, which have been manufactured
in accordance with the detailed guidelines on good manufacturing practice
for starting materials' (Directive 2001/83/EC as amended, article 46(f) for
Human Medicinal Products and Directive 2001/82/EC, Article 50(f) for
Veterinary Medicinal Products).
The
aim of the APIC Audit Programme is to provide a standardised Third Party
Auditing process to ensure that an effective assessment is performed of the
GMP status of APIs used as Starting Materials for Medicinal Products sold
within Europe and in so doing contribute to the assurance of the Quality,
Safety and Efficacy of the Medicinal Products.
You will find the
APIC
Auditing Programme here.
Please visit the Webpage of APIC/CEFIC to download further
Best Practice Guides.
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Reduced costs