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News about GMP/cGMP

2017-06-30

FDA: Revision of Draft on cGMP for Medical Gases

On June 28, 2017 the US FDA (Food and Drug Administration) published a revision of its draft guidance on medical gases entitled „Current Good Manufacturing Practice for Medical Gases Guidance for Industry“. This document is intended to supersede the guidance already issued in 2003.

 

Medical gases are regulated as pharmaceutical finished products by the FDA and must meet certain GMP requirements (21 CFR 210 and 211) regardless of their production stage. This guidance is intended to assist manufacturers of medical gases in meeting those. According to the FDA the guideline aims at reducing the regulatory compliance burden by providing clear, up-to-date, detailed recommendations regarding CGMP issues that have been the subject of industry questions. Compared to the previous version the text volume has been reduced significantly from 45 to 28 pages.

The following GMP requirements for medical gases are included:

  • Establishment of an effective quality system
  • Expectations on qualified personnel
  • Recommendations on building and facility design
  • Qualification of filling equipment and computerized systems
  • Control of components, containers, and container closure systems
  • Establishment of production and process controls
  • Establishment of accurate packaging and labelling controls
  • Establishment of holding and distribution procedures
  • Recommendations and general requirements for laboratory controls
  • Detailed recommendations on record keeping and reporting.

Comments and suggestions can be submitted within 60 days of publication. For more details please refer to the FDA draft guidance.

Source:
FDA: Draft Guidance on Medical Gases
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