FDA 21 CFR 211.188 – Pharma GMP

Never Transfer Previous Lot Data into New Batch GMP Records

digi — Tue, 14 Oct 2025 12:51:45 +0000

Never Transfer Previous Lot Data into New Batch GMP Records Don’t Carry Forward Previous Lot Data Into New Batch Records Remember: Never reuse or carry forward data from prior batches — each batch must be independently documented to preserve GMP data integrity. Why This Matters in GMP Each batch in pharmaceutical manufacturing must be treated...

Don’t Reassign Lots Without a Verified and Traceable Audit Trail

digi — Tue, 26 Aug 2025 22:13:36 +0000

Don’t Reassign Lots Without a Verified and Traceable Audit Trail Do Not Reassign Product Lots Without Maintaining a Verified Audit Trail Remember: Never change or reassign lot numbers without a fully documented and traceable audit trail authorized by Quality Assurance. Why This Matters in GMP Lot numbers are unique identifiers that allow pharmaceutical companies to...