EU Commission and EMEA Plan Extensive Further Development in the GMP Environment

GMP News
2 November 2007
 

EU Commission and EMEA Plan Extensive Further Development in the GMP Environment

 
At the second GMP Conference, held in Heidelberg, Germany, at the end of June, David Cockburn, Principal Scientific Administrator of EMEA's Inspections Sector, presented the timetable of the European Medicines Agency (EMEA) for the near future.

Through the Guideline ICH Q9 "Quality Risk Management", the principles of risk management will be embedded in the regulations in Europe, too. In detail, the plans are as follows:

  • Chapter 1 of the EC GMP Guide will be amended by Quality Risk Management.
  • ICH Q9 is planned to become the - optional (!) - Annex 20.
  • Within the framework of the next revision, Quality Risk Management is also meant to be included into Part II (ICH Q7[a]) and into the other parts of the EC Guide.
  • Risk Management is planned to be integrated into the Compilation of Community Procedures Quality. Thus, there will be more risk-based inspections in GMP supervision.

Apart from this, Chapter 5 of the EC GMP Guide is currently under revision. This includes:

  • Supplier qualification (with an indication that only APIs manufactured in compliance with the GMP rules can be used)
  • "Dedicated facilities" (with a reference also to Chapter 3 of the Guide)
  • Testing of raw materials (aiming at a harmonisation among all member states)
  • The most interesting changes will probably be those planned for Chapters 5.18/5.19 and 3.6 on "Dedicated Facilities".

    In addition to the above revisions of the EC GMP Guide, many of the annexes will be reviewed, too. The following changes are to be expected:

    • Annex 1 (sterile products) is meant to be modified again. Among other things, a closer connection to EN/ISO 14644 and to the FDA Aseptic Guide is meant to be created.
    • Changes to the Annex 2 (biological products) as an adaptation due to the revision of the EC GMP Guide in Parts I and II. Moreover, tissues are planned to be included.
    • Changes in Annex 3 (radiopharmaceuticals), Annex 6 (medicinal gases) and Annex 7 (herbal medicinal products) also as an adaptation due to the revision of the EC GMP Guide in Parts I and II.
    • Update of Annex 11 (computerised systems), here, the PIC/S document PI 011-2 will determine the basic contents.
    • Changes in Annex 13 (investigational medicinal products) regarding the storage of reference and retention samples. Clarification concerning the division between production and QC and clarification concerning release.
    • Changes are also planned for Annex 14 (blood products) in view of the EC Guideline 2002/98/EC.

    Some of the above-mentioned documents already exist as drafts for commenting by the public or are meant to be published by the end of this year. A highly ambitious undertaking.

    Author:
    Sven Pommeranz
    On behalf of the European Compliance Academy (ECA)
     

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