EU GMP Annex 1 is a specialized section under the rules governing medicinal products in the EU, focusing on the production of sterile medicinal products
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What is EU GMP Annex 1?



What is EU GMP Annex 1?

EU GMP Annex 1 is a specialized section under the rules governing medicinal products in the European Union, focusing specifically on the production of sterile medicinal products. The primary objective of this guidance is to produce contamination-free products. This is achieved by consistently applying the principles of Quality Risk Management (QRM) throughout the production process and placing special emphasis on the implementation of a formal contamination control strategy.

The Annex 1 guidelines underwent a comprehensive revision and became effective from 25 August 2023. For a more in-depth understanding, refer to Ansell's blog article, podcast and whitepaper on the topic.

How does the EU GMP Annex 1 guidelines impact Ansell and its products?

Ansell is a global manufacturer of personal protective equipment. We’re unique in the industry by way of owning and operating our own production facilities – ISO class 4 and 5 cleanrooms and two gamma irradiation facilities. Ansell has a portfolio of life sciences solution that focuses on barrier protection from head to toe as well as isolator and RABS gloves.

The EU GMP Annex 1 has mentions of these products and its best practices, which is why we can help provide manufacturing information regarding personal protective equipment to help our customers meet their EU GMP Annex 1 contamination control strategies.

Ansell proudly manufactures high-quality clean and sterile gloves, coveralls, RABS & Isolator glove systems, goggles, facemasks, and cleanroom accessories. Our customers not only benefit from the superior quality of these products but also their compliance with rigorous industry standards.

What is the role of Quality Risk Management & Contamination Control Strategy in ensuring the safety of products during production?

The quality risk management in the pharmaceutical industry is a thorough process that spans the entire production cycle. Its primary objective is to identify and control risks, ensuring that the end product, whether it's a sterile medicinal product or a STERILE medical device, is safe for use.

Contamination, in all its forms - whether in the form of particles, skin flakes, microbes or chemical residues is one of the main risks in medicinal products. The contamination control strategy is a fully documented and technical approach to keep the contamination controlled and within acceptable levels. However, with the EU GMP Annex 1 revision, all the different elements of the contamination control strategy are now defined and formalized and throughout the entire production cycle of the pharmaceutical products.

What are some of the key points specified in the EU GMP Annex 1 regarding ‘personnel’?

When it comes to personnel in the EU GMP Annex 1, the section places strong emphasis on assessment selection, proper usage, and training on cleanroom coveralls and gowning. The Annex 1 provides a detailed description of the specific clean & sterile PPE required for different cleanliness grades.

A key point to note in the updated Annex 1 is the defined need to wear sterile face masks and goggles in the grade B areas. The Annex 1 also underscores importance of selecting protective clothing that minimizes shedding due to operator movement. Coveralls should be packed and folded in such a way as to allow operators to don the gown without contacting the outer surface of the coverall and to prevent the coverall from touching the floor.

In response to these updated guidelines, Ansell has developed an innovative coverall fold technique. This method, designed to enable true aseptic donning also ensures that the wearer can gown without touching the external surface of the coverall. This approach, which aligns seamlessly with section 7.13i of Annex 1, showcases the advanced measures Ansell taken to ensure product and user safety.

What is aseptic donning and why is it important?

Aseptic donning method for cleanroom coveralls is a recommended approach to minimize contamination during the gowning process. Ansell, a leader in personal protection solutions, has introduced an innovative coverall fold technique that enables true aseptic donning.

Ansell's donning method ensures that cross-contamination is prevented before entering cleanroom environments. By folding up the coveralls to shorten their length, operators provide a better grip for easier donning, and the foot section of the coverall does not touch the floor when operators insert their legs into the pant/trousers part of the coverall. This method and the way Ansell cleanroom coveralls are packed minimize cross-contamination, protecting operators, and maintaining the integrity of products.

Ansell's donning guides, available in static and video formats, show how to don cleanroom coveralls according to strict guidelines stipulated in Annex 1. Operators are only allowed to touch the inner surface of the cleanroom coverall when donning.

Watch our video guide for the BioClean-D™ Coverall with Collar (S-BDCCT) to understand the steps involved in maintaining a sterile environment during the donning process.

For more detailed guides, check out our other donning videos: BioClean-D™ Coverall with Hood and Integrated Boots S-BDFC & BioClean-D™ Sterile Coverall with Hood S-BDCHT.

What is the importance of using barrier technologies?

The use of barrier technologies plays a very important role in protecting sterile medicinal products from external sources of contamination. Also, it can assist in rapid detection of contaminants in the sterile environment and the products. By using a RABS or an isolator, you are isolating that part of production from the surrounding sterile environment, which consequently can be a lower grade of cleanroom than if you were to produce in the cleanroom itself.

To better understand the practical application of these barrier technologies and to explore high-quality solutions, check out Ansell's comprehensive range of RABS & Isolator gloves. These gloves are specifically designed to offer the highest level of protection and compliance with industry standards.

What is the difference between RABS and Isolator Systems?

RABS (Restricted Access Barrier Systems) and Isolator systems are both designed to be physical barrier methods of product protection and containment that are used during manufacturing operations to separate operators from the process, but they serve different purposes and have distinct characteristics:

  • They are fully enclosed and separated from the surrounding environment.
  • They utilize automated bio-decontamination, frequently relying on vapourized hydrogen peroxide.
  • Throughout batch production, no interaction with the external environment is possible, which allows isolators to maintain Grade A conditions consistently.
  • Isolators often operate under continuous overpressure, ensuring that external contaminants cannot penetrate the system.
    RABS (Restricted Access Barrier Systems):
  • While RABS are enclosed, they aren't entirely sealed from the surrounding environment.
  • Disinfection and decontamination primarily occur when the process is offline.
  • Although interactions with the external environment are feasible in RABS, they are minimized whenever possible.

Both isolator and RABS systems utilize isolator gloves. The revised Annex 1 offers comprehensive guidelines on the selection, assessment, and proper use of these gloves. For instance, Annex 1 emphasizes the importance of the materials used in glove systems, insisting on "appropriate mechanical and chemical resistance".

Additionally, the Annex highlights that the frequency of isolator glove replacement should be defined within the Contamination Control Strategy (CCS). Leak testing of isolators is also crucial, mandated to be conducted at least at the start and conclusion of each batch or campaign.

For RABS systems, especially concerning gloves used in Grade A environments, the gloves should be sterilized before installation. Furthermore, they need to be either sterilized or bio-decontaminated prior to every manufacturing campaign. It's essential that the sterilization process is validated.

In summary, the revised Annex 1 places significant emphasis on RABS and isolators, reflecting their importance in ensuring sterility. To ensure that you're equipped with the best protective solutions, explore Ansell's range of RABS and Isolator glove systems. These gloves are designed to meet the rigorous standards of sterile environments and align with the specifications laid out in Annex 1.

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