Public consultation draft of the revised EU GMP Annex 1 out now.

The eagerly awaited public consultation draft of the revised EU GMP Annex 1 Manufacture of Sterile Medicinal Products has now been published after 2 years of development. The document has had a major rewrite with the content divided up into 10 sections covering the critical factors effecting the success of sterile product manufacturing process. 

The major change to text is the application of quality risk management principles throughout the document in all stages of manufacturing operation. Sterile product manufacture has always been subject to additional GMP controls as they are high risk operations, but the revised Annex 1 now requires an additional Contamination control Strategy, based on risk assessment to be implemented, maintained and reviewed periodically to ensure that product contamination risks are minimised.

So what would an appropriate contamination control strategy look like?

At Honeyman our Microbial Risk Management of Contamination (RMC) course presents a systematic approach to the management of contamination for sterile product manufacture. The system identifies microbial risks to a product, assesses the extent of the risk and where necessary, reduces it. The identified risks, or their methods of control, are monitored and limits established to ensure that contamination is correctly controlled. The system is then verified on a continuing basis to ensure that it is working effectively.

We have successfully applied the tools and techniques defined in this training for contamination control strategies to many applications with our clients including cleanroom start-up operations, manufacturing investigations, risk assessment and cleanroom classification. The feedback we receive from our clients on completion of projects is that they have an increased understanding of the fundamental mechanisms of contamination transfer, and are able to appraise their systems and improve contamination control within the facility.

As a result of the proposed changes in Annex 1 at Honeyman Group our Training courses in 2018 will include a review of the proposed changes to Annex 1 for the related subject areas and include discussion sessions on these changes.

The following courses have been updated.

Don’t miss out on our views on the proposed changes and how they may impact on your operations in the coming years and book your place on one of our training courses by clicking on the relevant links above.

If you would like to speak to one of our training experts, please email us on: with your details and we will get in touch with you soonest.

On behalf of the Honeyman Group, we hope to hear from you soon.

Thank you.

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