ALCOA principles – Pharma GMP

Never Sign Blank Fields in Controlled GMP Documents

digi — Fri, 30 May 2025 00:53:13 +0000

Never Sign Blank Fields in Controlled GMP Documents Signing Blank Fields in GMP Documents Is a Major Violation Remember: GMP documents must never be signed if data fields are blank—doing so risks falsification and breaches data integrity standards. Why This Matters in GMP Controlled documents like batch records, logbooks, and quality forms require complete, accurate,...

Never Rely on Memory to Record GMP Observations or Results

digi — Wed, 14 May 2025 14:14:57 +0000

Never Rely on Memory to Record GMP Observations or Results Document Observations Immediately—Don’t Rely on Memory Remember: All GMP observations and results must be recorded contemporaneously—memory is not a valid data source. Why This Matters in GMP In GMP environments, every observation, measurement, or deviation must be documented at the time it occurs. Delayed entries...

Do Not Record Test Results Before Completing the Analysis

digi — Sun, 11 May 2025 16:14:53 +0000

Do Not Record Test Results Before Completing the Analysis Record Test Results Only After Full Completion of Analysis Remember: Entering test results before completing the entire analysis violates data integrity and can mislead quality decisions. Why This Matters in GMP Premature documentation of test results is a critical GMP violation. Such entries misrepresent the actual...