OR WAIT null SECS
The agency determined additional guidance was needed to reduce regulatory compliance burden.
On June 28, 2017, FDA published guidance to provide additional clarification on current good manufacturing practices for the manufacture of medical gases that are regulated as pharmaceuticals. After review of regulations in the Food and Drug Administration Safety and Innovation Act, FDA decided to provide additional guidance regarding certain regulations of medical gases in order to reduce compliance burden on the industry. The guidance clarifies some requirements and offers up-to-date recommendations.
Under current good manufacturing practice regulations (21 Code of Federal Regulations parts 210 and 211), manufacturers of medical gases are required to ensure the safety, identity, strength, quality, and purity of medical gases to prevent serious injury or death. The guidance applies to medical gases that meet the definition of a drug under the Federal Food, Drug, and Cosmetic Act. The guidance states that “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.’”
Specifically, the guidance addresses 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. The validation of computerized systems is also detailed. There are sections detailing container closure systems, process controls, packaging and labeling, and distribution requirements. Laboratory controls including calibration of instruments, sampling and testing, test methods, stability testing, and reserve samples are addressed. A thorough section on data integrity details record and reporting requirements including record retention, computer validation data, equipment cleaning logs, master control records, batch records, laboratory records, and other data records.
This guidance supersedes the May 2003 draft guidance for industry, Current Good Manufacturing Practice for Medical Gases.