A company recently received this 483 observation:
…..Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test procedures designed to assure that components, in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
Specifically, there is no documentation or justification if GC and/or HPLC runs are repeated or aborted. For example, your firm performed a re-injection of ….. drug product sample, Lot ….., without documentation or explanation.
For more details on this observation as well as other observations pertaining to Laboratory Controls see Issue 1019 available today. It features observations pertaining to Active Pharmaceutical Ingredient (API) Manufacturing on our rotating page 3 topic as well as Medical Device Manufacturing Controls and Manufacturing Controls.