FDA Current Good Manufacturing Practice for Medical Gases Draft Guidance for Industry

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Draft — Not for Implementation 1 Current Good Manufacturing Practice for Medical Gases 1

2 Guidance for Industry 3 4 5 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 6 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 7 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 8 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 9 for this guidance as listed on the title page. 10 11 12 13 14 I. INTRODUCTION 15 16 This guidance is intended to assist manufacturers of medical gases in complying with applicable 2

17 current good manufacturing practice (CGMP) regulations (21 CFR parts 210 and 211). Medical 18 gases are generally regulated as finished pharmaceuticals and are subject to CGMP requirements 19 regardless of the processing stage. Compliance with applicable CGMP requirements helps to 20 ensure the safety, identity, strength, quality, and purity of medical gases. Medical gases that are 21 not manufactured, processed, packed, or held according to applicable CGMP requirements can 3

22 cause serious injury or death. 23 24 Pursuant to its review of Federal drug regulations under the Food and Drug Administration 4

25 Safety and Innovation Act (FDASIA), FDA determined, in part, that additional guidance 5

26 regarding the application of certain regulations to medical gases would be useful. This 27 document provides such additional guidance regarding CGMP regulations. This guidance is 28 expected to reduce the regulatory compliance burden for the medical gas industry by providing 1

This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Office of Regulatory Affairs at the Food and Drug Administration. 2

In this guidance, the term manufacturer includes any person or firm that manufactures a medical gas, which includes producing, cascading, distributing, filling, mixing, purifying, separating, transferring, and transfilling medical gases. See section XIV, Glossary, for definitions of different types of manufacturers. 3

A number of injuries and deaths have resulted from medical gases not being produced or handled properly. For example, there have been a number of incidents in which a medical gas container holding a gas other than oxygen was erroneously connected to a health care facility’s oxygen supply system. For further details regarding several of these incidents, see proposed rule “Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements” (71 FR 18039, April 10, 2006). 4

Public Law 112-144, 126 Stat. 993 (July 9, 2012); see section 1112(a)(2). 5

See FDA, 2015, Report to Congress: Review of Federal Drug Regulations With Regard to Medical Gases, available at http://www.fda.gov/downloads/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FDASIA/

UCM453727.pdf.

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