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The initial consequence of a pharmaceutical manufacturer’s failure to comply with CGMPs is an FDA warning letter.



for manufacturing violations and deviations from CGMPs.Biopharmaceutical companies must be able to provide evidence that data related to product manufacture are not compromised accidentally or intentionally.To ensure data integrity, a manufacturer must certify that data are legible, attributable, original, documented in real time, accurate, complete, consistent, and enduring. Otherwise, a company cannot state that data are uncompromised.False or questionable data can result in an adulterated product. can be defined as the assurance that data records (paper and electronic) are accurate, complete, intact, and maintained within their original context.