Changes to GMP Annex 1

What will change with GMP Annex 1 and how can CWS support pharmaceutical companies? An overview.

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24 January 2020 Cleanrooms

Changes to GMP Annex 1 expected in 2020

The first draft of the new GMP Annex 1 has received much attention. Due to the numerous comments a new draft is being prepared, which is expected to be published in 2020. As soon as we receive an update, we will gladly inform any interested customers.

GMP rules are binding

If the changes to GMP Annex 1 are then adapted, they are binding for all. These changes, similar to the ‘Good Manufacturing Practice’ (GMP) standards, determine the national and international requirements for hygiene, location, equipment, documentation and controls within the pharmaceutical environment. Annex 1 deals with the manufacturing of sterile medicines and was last revised in 2007. The new revision is therefore important to redefine quality standards.

Cover hair, skin and eyes completely

Among other things, the revised version of GMP Annex 1 provides regular employee training in terms of hygiene, cleanroom practices, contamination control and aseptic techniques. 

The clothing and its quality should be appropriate for the process and the grade of the working area. Hair, beards and moustaches must be covered and, in a grade C cleanroom, disinfected or sterilized shoes or overshoes (boots) must be worn. The grade A / B cleanroom requires sterile headgear, sterile face masks and sterile footwear (boots), sterile eye shields - i.e. goggles. The intention is to cover all facial skin and prevent the shedding of droplets and particles.

New requirements for cleanroom clothing and its handling

Numerous other changes are provided by the revised GMP Annex 1 regarding clothing. This includes, for example, that for every operator in a grade A/B area, clean sterilized protective garments including eye coverings and masks of an appropriate size should be provided at  each work session. Under the sterilized cleanroom garments, cotton or polycot undergarments should not be worn. In addition, cleanroom suitable socks should also be worn before entry to change rooms for grade C and B. Gloves should be regularly disinfected during operations.

"Companies should already be intensively involved with the planned changes and prepare themselves," explains Jörg Mesenich, Director of Sales & Account Management Cleanrooms at CWS Cleanrooms. "Example glasses: Before a customer decides on a product, it should be found in individual tests, which model is best suited for the planned application. As a result, CWS now provides its customers with comprehensive advice on the changes to Annex 1 and also provides test samples in order to find the optimum solution together.”

The fact that CWS starts consulting so early has a practical background, according to Mesenich: "The change in Annex 1 will lead to a surge in demand for cleanroom goggles, socks and other products. We expect hereafter adoption with delivery times of up to 4 months. Therefore, we already advise our customers today to deal with the changes and to prepare themselves. To do this, we are actively approaching and advising our customers. "

One tip that CWS had already taken note of in advance was that all processes in the cleanroom laundry already meet the intended changes. The goggle washers have also been in use at CWS for years, explains Britta Heck, Quality Assurance Cleanrooms. "Due to the proximity to our customers and our expertise, we invested in corresponding processes and systems at a very early stage," explains the quality manager, who - just like her colleague Jörg Mesenich - lectures to specialist audiences. "That's how we want to optimally prepare our customers for the upcoming changes."

Interested parties can take a guided tour to see how the goggle washing systems work and how the processes in the cleanroom laundry actually look. CWS cleanroom laundries meet the requirements of ISO Class 4 - 8 cleanrooms. CWS is working GMP Annex 1-compliant. Cleanroom textiles are washed, packed and sterilized according to the customer's specifications. Upon request, deliveries can be made  to gowning locations at the customer premises.