In the high-stakes world of life sciences, the distance between a breakthrough molecule and a successful market launch is measured in billions of dollars and decades of effort. For pharmaceutical and biotech companies, the traditional model of keeping every function in-house is rapidly giving way to a more agile, collaborative approach.
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1. Procedures not established or not followed (SOPs and process control)
Common cites: 21 CFR 211.100(a) (written production/process control procedures), 211.22(d) (quality‑unit procedures), and 211.100(b) (failure to follow and document deviations).
Inadequacy or absence of written procedures, deviation from established SOPs without proper justification is one of the major reasons for drug-product failure thus issuance of Form 483.
Under the Biosecure Act, US government agencies cannot:
(1) Buy or obtain biotechnology equipment or services provided by a BCC
(2) enter into, extend, or renew a contract with any entity using biotechnology equipment or services provided by a BCC to perform a government contract; or
(3) expend loan or grant funds for biotechnology equipment or services provided by a BCC, whether directly or through a loan or grant recipient.
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