10 BioPharm International eBook September 2019 www.biopharminternational.com
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
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AGNES SHANLEY
