Annex 1

EU GMP Support

Annex 1 of the EU GMP Guide was updated on 22nd Aug 2022 and will be effective from 25 Aug 2023, with the exception of point 8.123 regarding lyophilizers (effective date 25 Aug 2024). This update to Annex 1 has brought with it a series of clarifications on a number of topics related to the manufacture of sterile products and also includes in the scope products that are not intended to be sterile such as certain liquids, creams, ointments and low bioburden biological intermediates.

The revised Annex 1 has placed 2 concepts at its centre

  • Quality Risk Management (QRM)
  • Contamination Control Strategy (CCS)

Quality Risk Management:

The revised Annex 1 makes 124 individual mentions on risk throughout the document, compared with 20 in the previous version. The placement of risk as a central tenet of this document highlights the importance of risk based thinking when it comes to all aspects of the manufacturing process. It covers everything from facility design to the environmental monitoring program.

Contamination Control Strategy:

The development of a CCS document is a key element to the revised Annex 1 and it is made clear that the CCS may be used to support the manufacture of non-sterile products. The CCS is intended to be the core reference document describing how the site assures control of contamination  of the products manufactured within its facilities.

As a QP services company delivering QP Certification, QP Audits, QP Declarations and Supply Chain Services to global Pharma and BioPharma companies, MIAS Pharma is uniquely placed to assist in the implementation of the revised Annex 1 to the EU GMP Guide (Effective 25 Aug 2023).

Our team has a deep understanding of sterile manufacturing technology and so can provide guidance to your company to support the gap analysis phase, any resulting PQS improvements and implementation plans and also the drafting of a Contamination Control Strategy.

We can apply the lens of a QP to the manufacturing process, specifically what a QP would expect to see and what a QP would be looking for as part of the QP release process or during an audit.

In taking this approach together we can reduce risk, enhance compliance and continue to deliver critical medicines to patients.

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