IPEC e-newsletter - Excipients Insight March 2017 - 31-03-17


Inside this issue


ECA on GMP requirements for Certificates of Analysis

A recent article in ECA's GMP Newsletter reviews the requirements for Certificates of Analysis, the significance of which is growing owing to outsourcing and globalisation.

ECA notes that there are CoAs for excipients, active pharmaceutical ingredients (APIs), packaging materials and finished products, but adds that some regulatory requirements are "often unknown". Requirements can be found in the following sets of rules:

  • EU GMP Guide Part I (Chapter 4 and Chapter 6)
  • EU GMP Guide Part II - Section 11.4
  • EMA Guideline on batch certification (Internationally harmonised Requirements for Batch certification)
  • WHO Annex 10 - Model Certificate of Analysis
  • USP General Chapter <1080> Bulk Pharmaceutical Excipients - CoA
  • IPEC CoA Guide for Pharmaceutical Excipients

Ultimately, the user of such certificates has to rely on their accuracy and completeness, says the ECA. The IPEC Certificates of Analysis guidance is compliant with all of these regulations but please note they were specifically designed for excipients, not other products or materials.




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