{"id":2002001,"date":"2024-01-25T13:42:29","date_gmt":"2024-01-25T12:42:29","guid":{"rendered":"https:\/\/www.abovo.ch\/wissenswertes\/new-eu-gmp-annex-1-requires-contamination-control-strategy-ccs\/"},"modified":"2025-12-01T14:58:54","modified_gmt":"2025-12-01T13:58:54","slug":"new-eu-gmp-annex-1-requires-contamination-control-strategy-ccs","status":"publish","type":"knowledge","link":"https:\/\/www.abovo.ch\/en\/good-to-know\/new-eu-gmp-annex-1-requires-contamination-control-strategy-ccs\/","title":{"rendered":"New EU GMP Annex 1 requires contamination control strategy (CCS)"},"content":{"rendered":"\n

Since August 25, 2023, the revised version of EU GMP Annex 1 has applied with one exception, including the obligation to develop a contamination control strategy (CCS for short) and the obligation to wear plant socks <\/strong>when<\/strong> entering changing rooms in front of GMP B and C cleanroom areas.<\/strong><\/p>\n\n

The EU GMP Annex 1 is an important annex to the guidelines for the <\/strong>“<\/strong>Good Manufacturing Practice (GMP)<\/strong>“<\/strong> of the European Union, which was revised in 2022. It is a specific guideline that focuses on the requirements and recommendations for the manufacture of sterile medicinal products. <\/strong><\/p>\n\n

More in-depth information on the new contamination control strategy (CCS) and the new plant sock requirement <\/strong>regarding<\/strong> GMP B and GMP C areas in cleanrooms can be found in this article.<\/strong><\/p>\n\n

What the contamination control strategy (CCS) should include<\/h2>\n\n

Since August 25, 2023, the new EU GMP Annex 1 has required<\/strong> a comprehensive and overarching <\/strong> Contamination Control Strategy<\/strong>( CCS<\/strong>), which is to be used as a control instrument for the rational management of risks in the manufacture of medicinal products. However, Annex 1 does not provide any specific requirements for the structure of the CCS document<\/g>. A holistic risk-based approach to possible contamination hazards is expected<\/g>. The CCS is a formalization and summary of existing requirements. <\/p>\n\n

The following points <\/strong>should be taken into account in the contamination control strategy (CCS)<\/strong>:<\/p>\n\n

    \n
  1. <\/strong>Design of the system and the process<\/strong><\/li>\n\n\n\n
  2. <\/strong>Premises and equipment<\/strong><\/li>\n\n\n\n
  3. <\/strong>Personnel<\/strong><\/li>\n\n\n\n
  4. <\/strong>Operating resources<\/strong><\/li>\n\n\n\n
  5. <\/strong>Raw material control – IPC<\/strong><\/li>\n\n\n\n
  6. <\/strong>Product containers and closures<\/strong><\/li>\n\n\n\n
  7. <\/strong>Supplier approvals<\/strong><\/li>\n\n\n\n
  8. <\/strong>Evidence for outsourced services<\/strong><\/li>\n\n\n\n
  9. <\/strong>Process risk assessment<\/strong><\/li>\n\n\n\n
  10. <\/strong>Process validation<\/strong><\/li>\n\n\n\n
  11. <\/strong>Validation of the sterilization processes<\/strong><\/li>\n\n\n\n
  12. <\/strong>Preventive maintenance<\/strong><\/li>\n\n\n\n
  13. <\/strong>Cleaning and disinfection<\/strong><\/li>\n\n\n\n
  14. <\/strong>Monitoring systems<\/strong><\/li>\n\n\n\n
  15. <\/strong>Prevention<\/strong><\/li>\n\n\n\n
  16. <\/strong>Continuous improvement<\/strong><\/li>\n<\/ol>\n\n

    Assistance with the development of a contamination control strategy (CCS)<\/h2>\n\n

    Help<\/strong> in developing a contamination control strategy (CCS)<\/strong> is provided by the ECA<\/strong> Foundation<\/strong>, a non-profit organization that supports<\/strong> the pharmaceutical industry<\/strong> and regulatory authorities<\/strong> in promoting the transition to a harmonized set of GMP and regulatory guidelines by providing information and interpretation of new or updated guidelines.<\/p>\n\n

    In January 2022, the working group “ECA Task Force on Contamination Control Strategy” published<\/strong> a document<\/strong> to support those responsible in drawing up a contamination control strategy: “<\/strong>How to Develop and Document a Contamination Control Strategy<\/a>“<\/strong><\/p>\n\n

    Procedure for creating a CCS<\/h2>\n\n

    When creating the CCS, it is important to consider<\/strong> whether it is being created for a new or an existing plant and how far the company’s understanding of the process has already been developed.<\/p>\n\n

    For a new plant with little know-how<\/strong> in sterile production:<\/p>\n\n

      \n
    1. <\/strong>Acquire an understanding of the process<\/strong><\/li>\n\n\n\n
    2. <\/strong>Mapping of the manufacturing process to identify possible sources of contamination<\/strong><\/li>\n\n\n\n
    3. <\/strong>Risk assessment of all possible contamination hazards<\/strong><\/li>\n\n\n\n
    4. <\/strong>Establish preventive measures and controls including responsibilities <\/strong><\/li>\n\n\n\n
    5. <\/strong>Documenting evidence of the measures<\/strong><\/li>\n\n\n\n
    6. <\/strong>Assessment and control of the residual risk of contamination<\/strong><\/li>\n<\/ol>\n\n

      For an existing system<\/strong> or with good to very well-developed know-how<\/strong>:<\/p>\n\n

        \n
      1. <\/strong>Evaluation of existing contamination control measures<\/strong><\/li>\n\n\n\n
      2. <\/strong>Analysis and overview of possible gaps<\/strong><\/li>\n\n\n\n
      3. <\/strong>If necessary, supplement further measures<\/strong><\/li>\n\n\n\n
      4. <\/strong>Assessment and control of the residual risk of contamination<\/strong><\/li>\n<\/ol>\n\n

        Data evaluation<\/h2>\n\n

        One of the challenges for pharmaceutical manufacturers is to obtain<\/strong> a holistic view of the large amount of data<\/strong> that they have collected with the CCS control systems. In this respect, Annex 1 explicitly requires that a system supports the manufacturer in the evaluation<\/strong>. <\/p>\n\n

        \"\"<\/a><\/figure>\n\n

        Source: https:\/\/www.fostec.com\/de\/kompetenzen\/big-data\/<\/a><\/p>\n\n

        Monitoring<\/h2>\n\n

        A continuous target\/actual comparison<\/strong> is important so that deviations in quality can be identified in good time and rectified with the necessary precautions. Monitoring<\/strong> is carried out in various areas, including general procedures, particles and microbiology, cleanroom classification and cleanroom personnel. <\/p>\n\n

        Cleanroom staff and new sock requirement<\/h2>\n\n

        When it comes to employees in the cleanroom<\/strong>, it is important for staff<\/strong> to be properly trained<\/strong> in the following points:<\/p>\n\n