A critical look at the new Annex 1 draft of the EU GMP

10/07/2018 -

On 20 December 2017, the European Medicines Agency (EMA) published the draft for the new Annex 1 “Manufacture of Sterile Medicinal Products”. At QbD, we did a critical analysis on the new Annex, including a thorough discussion on the main changes and their impact on day-to-day operations.

In our previous news item on the new Annex 1, we already announced that it had expanded significantly. In fact, the guideline has grown from 16 to at least 50 pages, describing Good Manufacturing Practices of Sterile Medicinal Products in more detail.

The document is now better aligned with the WHO Annex 6 (WHO Good Manufacturing Practices for Sterile Pharmaceutical Products) and the PIC/S Annex 1 (Manufacturing of Sterile Medicinal Products) but offers more detailed advice (WHO and PIC/S guidelines have respectively 24 and 17 pages).

The comprehensive chapter 8 “Production and Specific Technologies” deals with techniques like Blow Fill Seal. Chapters about Premises and Equipment are also more detailed, while the chapter about Utilities is completely new. Overall, the Annex contains 11 chapters, covering various aspects – from the Pharmaceutical Quality System to Quality Control, and from Personnel to Premises, Equipment and Utilities.

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