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GMP Training – Quality Assurance and Quality Control by www.gmpsop.com
(b) The failure to comply with any regulation set forth in this part and in parts
211 through 226 of this chapter in the manufacture, processing, packing, or
holding of a drug shall render such drug to be adulterated under section
501(a)(2)(B) of the act and such drug, as well as the person who is responsible
for the failure to comply, shall be subject to regulatory action.
International GMPs
GMP rules do not specifically define a "quality" product however they do define
under what conditions a batch may be released to the marketplace:
"Medicinal products are not sold or supplied before an authorized person has
certified that each production batch has been produced and controlled in
accordance with the requirements of the marketing authorization and any other
regulations relevant to the production, control and release of medicinal
products.''
Quality principles
Everybody has a different understanding of the term "quality". However, in the
pharmaceutical industry, quality is very specifically defined. Quality is the sum
total of a product's purity, identity, effectiveness, and of course, its safety.
Identity
Quality
Efectivenesss Safety
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