documentation audit – Pharma GMP

Do Not Leave Batch Records in Uncontrolled Office Areas

digi — Sun, 25 May 2025 05:44:50 +0000

Do Not Leave Batch Records in Uncontrolled Office Areas Keep Batch Records Secure—Never Leave Them in Uncontrolled Offices Remember: GMP documentation such as BMRs must be stored in secure, access-controlled locations—not left unattended in uncontrolled environments. Why This Matters in GMP Batch Manufacturing Records (BMRs) are critical GMP documents containing traceable evidence of every stage...

Do Not Allow Incomplete Documentation During GMP Batch Record Review

digi — Sat, 24 May 2025 06:08:35 +0000

Do Not Allow Incomplete Documentation During GMP Batch Record Review Do Not Proceed With Batch Review if Documentation Is Incomplete Remember: GMP batch records must be complete in every detail—blank fields or missing data are serious violations and must be corrected before review. Why This Matters in GMP Batch Manufacturing Records (BMRs) document every stage...