BioPharm International - September 2019

BioPharm - Regulatory Sourcebook

Issue link:

Contents of this Issue


Page 9 of 44

10 BioPharm International eBook September 2019 Regulatory Sourcebook Good Manufacturing Practices Is it Time to Update cGMPs? Industry practice has changed radically over the past five decades. Can laws published in the 1960s still ensure pharmaceutical quality and safety today? I n the pharmaceutical industry, it often takes trag- edy to lead to the passage of important laws. The Food, Drug, and Cosmetic (FD&C) Act of 1938, which established FDA's authority over questions of drug safety in the United States, was passed after more than 100 people in 15 states died. The victims had ingested the first liquid form of sulfa- nilamide antibiotic, dissolved in a toxic—and at that point untested—solvent, diethylene glycol (1). Current good manufacturing practices (cGMPs)— which set firm requirements for the safe manufac- turing of finished drug products, and for plant and process design and operation—were passed in 1963 to update the FD&C Act. They came as a response to deaths caused by Winthrop Pharmaceutical's failure to prevent cross-product batch contamination. The company had used two tableting machines within the same room, interchangeably, to manufacture antibiotic and anticonvulsant tablets. Lax controls led to the release of antibiotic tablets that had been contaminated by the anticonvulsant at two to three times the non-lethal dose; hundreds of people died or were hurt after taking the contaminated antibi- otic (2–4). Comprising the US 21 Code of Federal Regulations (CFR) Parts 210 and 211, and 212 for some radiophar- maceuticals, cGMPs aim to ensure that pharmaceuti- cal processes and facilities are designed, monitored, and controlled properly, says Michael Kopcha, direc- tor of the Office of Pharmaceutical Quality (OPQ), at Yabresse - AGNES SHANLEY

Articles in this issue

Links on this page

Archives of this issue

view archives of BioPharm International - September 2019 - BioPharm - Regulatory Sourcebook