Report on the prevention of microbial contamination of medicinal products.

  • Great Britain. Medicines Commission.
Date:
1973
Catalogue details

Licence: Open Government Licence

Credit: Report on the prevention of microbial contamination of medicinal products. Source: Wellcome Collection.

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    1. BACKGROUND TO THE FINAL REPORT 1.1 On 16 March 1972, the Secretary of State for Social Services announced in Parliament that he had invited the Medicines Commission, “in pur- suance of their functions under the Medicines Act 1968, to arrange for an immediate review of measures which should be taken in the course of production, distribution, storage and use of medicinal products to prevent them becoming vehicles of infection’. At their meeting on 29 March 1972 the Commission appointed a Com- mittee with the following membership: The Lord Rosenheim KBE MD FRCP FRS (Chairman) Dr F. Hartley CBE BSc PhD FPS FRIC Dr G. E. Paget MD Professor E. F. Scowen DS McD FRCP FRCS FRCPE FRCPath Professor R. E. O. Williams BSc MD FRCP FRCPath Professor A. Wilson CBE PhD MD FRCP FPS to consider the remit from the Secretary of State and to report to them. The Commission directed that, as a first priority, consideration should be given by the Committee to measures relating to sterile products. 1.2 The Committee produced an interim report on the manufacture of heat sterilized infusion fluids for parenteral administration which was accepted by the Medicines Commission on 20 July 1972. Thereafter the interim report was submitted to the Secretary of State who accepted it and published it on 14 August 1972. 1.3 The Committee have been pleased to learn that the United Kingdom Health Departments took immediate steps to bring the interim report to the attention of those concerned with the manufacture of heat sterilized infusion fluids, both in industry and the hospital service. 1.4 The remainder of the Committee’s remit involved consideration of the following topics: Chapter Il: Sterilization by methods other than the use of steam. Chapter 11[: The manufacture of sterile products other than infusion fluids; contamination hazards in non-sterilized products. Chapter 1V: Additions to intravenous infusion fluids. Chapter V: Indicators and tests in the sterilization process. Chapter VI: Points arising from the report of the Committee set up under Mr C. M. Clothier Qc to inquire into the circum- stances which led to the use of contaminated infusion fluids at Devonport Hospital, Plymouth, in March 1972. 1.5 The Committee decided that problems relating to the sterilization of devices, equipment and appliances lay outside their remit. Although many of the Committee’s recommendations apply to the manufacture of blood 6