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Annex 1 of the revised GMP: deadline of 25 August 2023 for compliance

After several years of work, Annex 1 of the GMP (Manufacturing of Sterile Products) has been updated.
What is it? Who will be impacted? What changes will be required and how can we help you? You can find all the answers below.

What exactly is Annex 1?

Annex 1 deals with the Manufacturing of Sterile Products and is one of the twenty annexes that make up the Good Manufacturing Practices (GMP) guide.

Intended for companies in the pharmaceutical industry, Annex 1 shows the principles and guidelines for the aseptic/sterile manufacture of medicines for human and veterinary use.

What are the impacts on cleanroom environments?

Cleanroom clothing and its quality must be appropriate to the process and grade of the work area. According to Chapter 7, Paragraph 13 of the Annex 1, this now means : 

  • Grade A/B: It becomes necessary to have sterilised headgear, gloves, eye coverings, shoes and mask, in combination with sterile upper garments and undergarments which must be worn under a sterile suit.  
  • Grade C: Operators must cover their hair, beard, moustache and have dedicated socks. They should also wear disinfected trousers and shoes. 
  • Grade D: Hair, beards and moustaches must be covered. A general protective suit and properly disinfected shoes (or overshoes) must be worn.

What other changes are expected?

One of the new elements is “outdoor clothing including socks […] should not be brought into changing rooms leading directly to grade B and C areas” (chapter 7.14).

Moreover, it is detailed in Chapter 8.46 that items which are not used immediately after sterilisation must be stored in appropriately sealed packaging. Clarification is also given regarding equipment that cannot be sterilised and which is necessary for aseptic process. Once disinfected, it must be protected to prevent recontamination (Chapter 8, paragraph 49).

Faced with these changes for your activity, Elis Cleanroom will support you with its products, thus adapting to your needs: socksautoclaved bags, ...

Why use our specialist laundries?

In its revision, Annex 1 also stipulates in Chapter 7. Paragraph 17 that “Reusable clean area clothing should be cleaned in a laundry facility adequately segregated from production operations, using a qualified process ensuring that the clothing is not damaged and/or contaminated by fibres or particles during the repeated laundry process. Laundry facilities used should not introduce risk of contamination or cross-contamination [..] After washing and before packing, garments should be visually inspected for damage and visual cleanliness. The garment management processes should be evaluated and determined as part of the garment qualification programme and should include a maximum number of laundry and sterilisation cycles”.

At Elis, our specialised cleanroom laundries all have a Helmke drum and carry out an additional visual inspection on each item, this enabling us to comply with Annex 1. 

Thanks to our experience and knowledge, our teams can assist you from A to Z in analysing your needs, determining together with your team which products are best suited to your sector, how to comply with Annex 1, etc.

To get an idea of what you need to do, get in contact with us by clicking on the reg tag to the right. 

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