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At ProSys Technology, we pride ourselves in keeping you up to date with the latest in the Pharmaceutical and Biopharmaceutical industry.
Did you know that the European Union has released a drafted version of Annex 1? This is expected to be implemented from August 25, 2023. The new requirements will affect the manufacture of sterile medicinal products, including those imported from non-Member States. But, what’s changed? What will this mean for manufacturing within the Pharmaceutical and Biopharmaceutical industries?
One of the major changes revolve around a planned approach to Quality Risk Management through heightened restrictions with Contamination Control Strategy, particularly around movement between clean zones, personnel presence, and documentation requirements.
The concept of Contamination Control Strategy (CCS), is expected to be much further developed than in the current Annex 1 and really is the core of the document.
In fact, the CCS is no longer only a Quality Assurance mission, but a multidisciplinary effort, which should be comprehensively documented and supported in validated manufacturing and control methods.
Contamination Control Strategies require through process and knowledge:
- All potential sources of contamination should be identified.
- Critical control points should be noted.
- The effectiveness of the implemented controls should be monitored, assessed, investigated and trended.
To drive continuous improvement, the CCS should be regularly reviewed and updated where appropriate. The Pharmaceutical Quality System also gains importance here.
Some aspects of the Pharmaceutical Quality System are expected to be added in Annex 1, to address specific requirements of sterile product manufacture and to ensure that all activities are effectively controlled, resulting in reduced contamination in sterile products.
How will the “Premises” and “Disinfection” sections be affected?
- Only materials and equipment that have been included on an approved list, developed during the validation of the transfer process and should be allowed to be transferred into Grade A or Grade B areas.
- Isolators or Restricted Access Barrier Systems (RABs), must be designed to provide protection of the Grade A environment.
- Air supply of clean areas and pressure cascades in cleanrooms will also have new requirements to meet.
- The need to establish a cleaning and disinfection written program, while monitoring its effectiveness, and validating the disinfection process. Annex 15 mentions the effective removal of disinfectant residues, this is now expected to also become a requirement.
Aseptic Process Simulation (APS/Media Fill) is a big topic in the revision. Media Fill is applicable to not only filtered liquids but also to non-filterable formulations, sterile powders, lyophilised products and production campaigns.
Guidance is offered on the critical manufacturing steps, with a slight focus also on the lyophilised products, and interventions that should be included during the process. While developing the APS plan, many factors need to be considered; container size; line speed; volumed filled; agitation; the use of bracketing approaches; holding times; selection of culture media; gas usage; APS duration; shift changeovers etc.
In conclusion, the revision of Annex 1 will introduce several new requirements and clarify some outstanding ones. The two main concepts to retain are Contamination Control Strategy and Quality Risk Management, both widely mentioned throughout the document.
This is the perfect example of the saying of…
“If you fail to prepare, you prepare to fail”
For further advice on the Annex 1 revisions or any other concerns, please contact us by either popping over an email, by clicking here; or give us a ring on +353 21 485 3900.
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