Medical Device Regulation – Article 117 Action Required
Revision of Annex 1 “Manufacture of Sterile Medicinal Products” is published for comments First published in 1971, Annex 1 has been updated in target areas several times. However, this is the first time it has undergone a complete review. In recent years, it has become evident that the current Annex 1 has not kept pace with current regulatory and technological advancements and hence a complete review was necessary. According to European Commission ‘this revision is intended to add clarity, introduce the principles of Quality Risk Management to allow for the inclusion of new technologies and innovative processes and to change the structure to a more logical flow.’ Overall, the document has increased in size from 16 pages to 50 pages. The ammendments to the Annex intended to give the document a clear structure with a sensible sequence of its contents sections reflected by the table of contents below. Scope: Updated to include additional areas where the general principles of the annex can be applied Principles: General principles as applied to the manufacture of medicinal products including the requirements for contamination control strategy Pharmaceutical Quality System: Highlights the specific requirements of the PQS when applied to sterile medicinal products Personnel: Guidance provided on the requirements for specific training, knowledge and skills including the qualification of personnel Premises: General guidance regarding the specific needs for facility design and also guidance on the qualification of facilities including the use of barrier technology control Equipment: General guidance provided on the design and operation of equipment with the application of QRM principles Utilities: Guidance on the required equipment and/or other materials that may come into contact with a product or influence it directly. The section covers water systems, steam used for sterilisation, compressed gas and vacuum and cooling systems Production and specific Technologies: Guidance provided on the approaches to be taken with respect to aseptic and terminal sterilisation processes. Different technologies such as single use, lyophilisation and Blow Fill Seal/Form Fill Seal where specific requirements are necessary will be discussed. The approach to sterilisation of products, equipment and packaging components will also be discussed. Viable and non-viable environmental and process monitoring: Guidance on on-going routine monitoring with regards to the setting of alert limits and reviewing trend data. Quality Control: Guidance provided on some of the specific Quality Control requirements relating to sterile medicinal products Glossary: Explanation of specific terminology Complete details on the new contents can be found directly in “Annex 1 Manufacture of Sterile Medicinal Products“. The consultation period runs from 20 December 2017 to 20 March 2018 and details on commentation can be found at the link below. https://ec.europa.eu/health/human-use/quality/developments/pc_2017_12_sterile_medicinal_products_en For further information on how MPI can assist your organisation, please contact us at +353 1 846 47 42 or contactirl@pharmalex.com.
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