Three Key Takeaways from the PDA Annex 1 Workshop

Since the publication of the first draft version of EudraLex Volume 4 Annex 1 “Manufacture of Sterile Medicinal Products” [1] the PDA has organized numerous workshops across the globe. The Workshop event in Dublin was the 15th and last in this setting and participants had the opportunity to ask a panel of experts and regulators about topics related sterile manufacturing and the guidance provided in Annex 1.

This resulted in active engagements during the various panel and round-table discussions that centered on interpretation of some of the text of Annex 1 and observations made by regulatory bodies, not only from representatives from the industry but also from regulators. Discussion points raised included:

  • Regulators perspective since Annex 1 became effective.
    The Regulatory presenters reiterated that companies must understand that risk assessments or an aseptic process simulation cannot be used to justify bad practices that could pose a risk for the introduction of microbiological contamination.
    According to an inspector from Ireland, from the 29 inspections held in Ireland to date, the most commonly cited observation was in relation to the CCS where the CCS is still not captured as one central document.
  • Quality Risk Management
    The presenters stressed the importance of avoiding the creation of large numbers of disconnected risk assessment efforts, as efforts should be cross functional and stream lined through a risk assessment portfolio. A QRM master plan is a useful tool as its contents should indicate what living risk assessments are present or to be created across a company, what the timelines are for completion or revision. This avoids that living risk assessments are completed all together and allows for making decisions based on criticality and can be categorized as such.
  • Knowledge Management
    It was noted that living risk assessments are also an important factor when it comes to knowledge management within a company and is about the insights of personnel, the ability knowing what to do based on the information provided, available data and knowledge itself. Personnel on the work floor have the tacit knowledge about the process and equipment, they know the “why” and “how” that a company can build on. It was also mentioned that time to invest in training was one of the most challenging factors for a company.

 

References

  1. EudraLex Volume 4 Good Manufacturing (GMP) Guidelines – Annex 1, Manufacture of Sterile Medicinal products (2022) . Accessed through: https://health.ec.europa.eu/system/files/2022-08/20220825_gmp-an1_en_0.pdf

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This blog is intended to communicate PharmaLex’s capabilities which are backed by the author’s expertise. However, PharmaLex US Corporation and its parent, Cencora, Inc., strongly encourage readers to review the references provided with this article and all available information related to the topics mentioned herein and to rely on their own experience and expertise in making decisions related thereto as the article may contain certain marketing statements and does not constitute legal advice. 

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