Annex 1 – Revolution in GMP heaven?

The new Annex 1

a document that is awaited with more excitement than ever before in the history of GMP regulations. One reason for this is that Annex 1 has now been available as a draft for more than 4 years and its publication has been repeatedly delayed for various reasons. According to current information, the publication is now scheduled for September 2022.

What is new and therefore very special?

On the one hand, the (recommended) scope of Annex 1 has been significantly expanded. In future, the focus will no longer be solely on the manufacture of sterile medicinal products, but it is recommended that “principles can also be used to support the manufacture of other products that are not intended to be sterile, such as certain liquids, creams, ointments and biological intermediates with low biological load”. It can therefore be assumed that the requirements, e.g. for the definitions of cleanroom zoning and the associated qualification and implementation of monitoring, will then also be applied to other production facilities that were not previously included in the Annex 1 control loop.

Monitoring of processes

The topic of monitoring processes, including the requirements for the expertise of all those involved in the value creation process, is then very much in focus and clear expectations are defined. For example, the specification of the bacterial load in the A zone changes from previously < 1 CFU/m³ air volume in the monitoring of room conditions to 0 CFU/m³ (“no growth”) with the expectation that every occurrence of a germ is immediately transferred to an investigation (deviation), with the requirement that the “real cause” is also determined. Annex 1 then formulates the requirement that the process control in the manufacture of sterile medicinal products is closely monitored, e.g. with the requirement of QA monitoring through windows in the cleanroom that allow a complete view of the processes, or alternatively by means of recording cameras.

The central theme in Annex 1

however, is the requirement to implement a so-called contamination control strategy (CCS) in the company, which, on the basis of a detailed risk analysis, determines the corresponding assessments of possible influencing factors for the occurrence of particulate or microbial contamination and defines the strategic measures for defense / monitoring. In the current reading of the new Annex1 , this is to be interpreted as meaning that, in addition to the SMF and VMP, a further strategy document should be created and maintained at a high level in the company’s organizational structure on the basis of a well-implemented risk management system.

Overall, Annex 1 has become much more technical. This is the first time that the media systems have been recorded in great detail and clear requirements for the design / definition of acceptance criteria have been formulated and specified.

APS (Aseptic Process Simulation)

A large part of the new Annex 1 is taken up by the actual production, including the chapter of the APS (Aseptic Process Simulation) formerly known as MediaFill. There are not necessarily any revolutionary changes, but there is a significantly greater specification of current practice combined with the requirements for the qualification of those involved and the targeted use of the risk management system.

Conclusion

Very exciting, very ambitious. With publication, it will be a major task in the company to evaluate the many clarifications / new requirements and changes, and to derive and implement the right conclusions with regard to implementation.

More information

Please contact us for further training and consulting services relating to Annex 1 via e-mail info@expertsinstitut.de

Target group

The online seminar is no longer only aimed at employees working with sterile medicinal products, but is open to the entire spectrum, i.e. everyone involved in the implementation / execution of Annex 1 in the company. Departments such as production, quality, QA / QC, as well as engineering, plant manufacturers and also inspectors benefit from the knowledge imparted in this seminar. Contact: info@expertsinstitut.de

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Dipl. Ing. Wolfgang Rudloff

Vita

• 30 Jahre Erfahrung in der pharamzeutischen Industrie

Expertise:

• Geprüfter Sachverständiger für Reinraumtechnik und GMP-Management
• Lead Auditor und Gutachter

Stationen:

• Technischer Leiter
• COO / Gesamt-Herstellungsleiter
• Remidiation-Manager
• Projektleiter Neubau/GMP-Upgrade
• Management-GMP-Beratung
• Fachautor, GMP-Trainer, Mediator