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Executive Briefing Series (formerly The Food & Drug Letter)
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Regenerative medicine is a rapidly expanding, lucrative field and continued growth is expected. Sections 351 and 361 of the Public Health Service Act (PHS Act) [42 USC 264] aim to prevent the introduction, transmission and spread of communicable diseases through the procurement, processing and use of certain human cells, tissues, and cellular and tissue-based products (HCT/Ps) in regenerative medicine. Section 351 is the more stringent of the two because HCT/Ps that fall under that section are regulated as drugs, devices and biological products. The FDA implemented 21 CFR Part 1271 — Human Cells, Tissues, and Cellular and Tissue-based Products to define and regulate HTC/Ps in conjunction with Sections 351 and 361 of the PHS Act.
Environmental and biological monitoring of drug manufacturing sites gives drugmakers the information they need to comply with FDA and EU regulations on the manufacture of sterile drug products. Monitoring provides critical information on the hygienic status of the sites and thus on the success of cleaning and disinfecting measures. Surfaces, personnel, air, utilities and cleansing agents and disinfectants all have to be tested. Alert and action limits have to be set, as well as measures to be taken if those limits are exceeded.
Each step in the drug manufacturing process involves potential risks to the product quality and,
as a result, to the patient. However, the risks associated with manufacturing are only one part of the overall risk to the drug during its life cycle. This life cycle includes the development of drug substances, the manufacture of drug substances and excipients, the development of the drug, clinical testing, manufacture, marketing and use by patients, and ends with its withdrawal from the market.