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The most important thing about the new EU GMP Annex 1

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Banner GMP Annex 1

EU Annex 1 is a guide that defines the requirements for a clean room in the pharmaceutical industry and serves as a reference for monitoring and checking compliance with these requirements.

The new one was in August 2022 EU Annex 1 adopted. Its validity comes into effect August 25, 2023 in force. Until then, companies in the cleanroom industry have the opportunity to make adjustments to the new EU Annex 1 and meet the necessary requirements.

Basically, the structure has remained unchanged, but Annex 1 extensive become. There is a higher intensity of description and elaboration of individual parts. The 59 pages (with glossary) now provide very clear instructions on how pharmaceutical companies should proceed in their clean rooms.

The biggest paradigm shift in the new EU Annex 1 is Contamination Control Strategy (CCS) period.

This consists of a document that identifies and assesses contamination risks, determines containment options and defines preventive measures; that can be associated with the full extent of possible contamination of sterile products.

It is important to summarize all precautions against contamination and to look at them more intensively in the individual departments and to establish the principles of one Contamination control strategy (CCS) to be implemented throughout the facility.

The goal for every pharmaceutical company should be to have every analysis carried out summarized in one document. This document should be able to confirm that all strategies within the individually examined areas are so successful that there is no contamination from outside and that the risk within the process can be controlled.

In summary, this is Contamination control strategy the leading element and firmly anchored in the life cycle, because it has to be constantly changed and adjusted.

The aim of the new EU Annex 1 is to think more broadly than just microbacterial and particulate contamination control. The following points play an important role here:

  • What happens at goods receipt?
  • What risk input do the suppliers have for the process? (Filter suppliers, new machine suppliers, etc.)
  • Extensive observation of what flows in from outside

In addition, a new product quality assurance (PQS) was introduced in Annex 1 and its tasks were described in detail.

Another point is that the scope of “manufacture of sterile drugs” has been expanded. Since then, sterility has been required not only for medicines, but also for active ingredients, packaging, etc.

Tip for manufacturers of non-sterile products:

The scope can also be used on non-sterile products and should definitely be examined more closely. The reason for this is that the EC Guide/EUGP Guide provides fewer specific requirements for non-sterile products. Annex 1 gives you a tool to take a closer look at your processes. You have the opportunity to get suggestions for more hygiene and cleanliness.

Amendments

We list them all below Changes to focus topics on how Disinfection/cleaning, Equipment and personnel. We would be happy to support you with the implementation and also have the opportunity to find the optimal solution for you through our extensive product portfolio.

  • Chapter 4.22
    • The cleaning process before the biological decontamination step is essential
    • The Cleaning and sporicidal biodecontamination should clean the interior surfaces of a clean room and the critical zone of isolators of viable microorganisms
    • Sporicidal disinfection should include routine use of a sporicidal agent according to a validated method that has been proven to cover all areas of the internal surfaces and ensure a suitable environment for aseptic processing
  • Chapter 4.33
    • Clean rooms should be cleaned and disinfected. The cleaning programs should effectively remove disinfectant residues. More than one type of disinfectant should be used. The disinfection of should be documented in writing. Further, disinfection should include regular use of a sporicidal agent
  • Chapter 4.34
    • The disinfection procedure should be validated
  • Chapter 4.35
    • Disinfectants and cleaning products used in Class A and B areas should be sterile before use. Sterility may also be required for disinfectants used in classes C and D if specified in the CCS
  • Chapter 5.4
    • The cleaning procedure should be validated to remove any residue or debris that could reduce the effectiveness of the disinfectant used
  • Chapter 7.13
    • In Class A and B cleanrooms, staff should wear appropriate clothing intended for use under a sterilized suit before donning the gown
    • Appropriate sterilized, powder-free rubber or plastic gloves should be worn when putting on sterilized clothing. A sterile headgear should cover all hair. A sterile face mask and sterile eye coverings (e.g. goggles) should also be worn
    • Appropriate sterilized shoes (e.g. overboots) should be worn
    • The sleeves of the gown should be tucked into a second pair of sterile gloves worn over the pair worn when donning the gown
    • In clean rooms of the Class C Hair and beards should be covered. A one- or two-piece pants suit with cinched wrists and a high neckline, along with appropriately sanitized shoes or shoe covers, should be worn
    • In clean rooms of the Class D Hair, beards and mustaches should be covered. A general protective suit and appropriately disinfected shoes or shoe covers should be worn
    • In areas of Classes C and D Additional protective clothing including gloves and a face mask may be required when carrying out activities that pose a risk of contamination according to the CCS definition
  • Chapter 7.14
    • Changing should take place in changing rooms with an appropriate level of cleanliness to ensure the cleanliness of clothing
    • Before entering the Class B and C locker rooms, one- or two-piece pantsuits that fully cover the arms and legs and socks that cover the feet must be worn
  • Chapter 7.15
    • Anyone entering Class B or Class A areas should wear clean, sterilized protective clothing (including eye protection and a mask) of appropriate size each time they enter
  • Chapter 7.16
    • Gloves should be disinfected regularly while working. Clothing and gloves should be changed immediately if they are damaged and pose a risk of product contamination

If you have any questions, concerns or would like individual solutions, please contact us at number 0531 230469-0

Your HEIN Reinraum Team