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including active materials and excipients
for example AOAC
You must calibrate before first use
and to propose necessary corrective measures
supplying or exporting medicinal products or active ingredients
9.0 - Retention Requirements of GMP Records and Reports 111.535 including active materials and excipientsAny production, control, or distribution record associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch or, in the case of certain OTC drug products exempted from expiration dating, 3 years after distribution of the batch, readily available for authorized inspection
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