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CGMP Guidance for Medical Gases

Earlier medical gases were regulated as pharmaceuticals. Considering its nature and properties, FDA has published new guidelines for the current good manufacturing practices (CGMP) for the manufacturing of medical gases. The guidelines were developed to provide additional guidance regarding regulations of medical gases in order to provide more compliance for industry. The updated guidelines provide recommendations and clarify industry requirements.

Following points are relevant under current good manufacturing practice regulations (21 Code of Federal Regulations parts 210 and 211), which manufacturers are required to pay attention in order to prevent serious injury or death. They are:

 According to Federal Food, Drug, and Cosmetic Act,  “a medical gas that meets the definition of a drug (referred to in this guidance as simply a medical gas) is deemed to be adulterated under section 501(a)(2)(B) of the FD&C Act if ‘the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice.”

Besides covering the safety and purity part, the guidance particularly pay emphasis on organization and personnel in regards to the quality unit and personnel qualifications. Facility and equipment requirements are also discussed, including equipment cleaning, maintenance, and calibration. A detailed section is present to discuss the validation of computer systems employed in the unit. Further, sections are present detailing container closure systems, process controls, packaging and labelling and distribution requirements. Various records are maintained in order to attain compliance for example: data integrity details record, reporting requirements including record retention, computer validation data equipment cleaning logs, master control logs, laboratory records and other data records. In addition to this, Laboratory controls including calibration of instruments, sampling and testing, test methods; stability testing and reserve samples are addressed.

Therefore, this guidance provides a comprehensive approach to manufacture medical gases and adhere to regulatory compliance.



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