The common data integrity problems that have been observed by FDA inspectors in past: Non contemporaneous Recording: Failure to record activities at the time when activity was performed. There is evidence that the records were signed by company personnel when the person was actually absent on that day. Document back-dating: Backdating stability test results to meet the required commitments. Copy of existing data as new information: Test results from previous batches were used to substitute testing for another batch or acceptable test results were created without performing the test. Re-running samples to obtain better results: Multiple analyzes of assay were done with the same sample without adequate justification and in some cases samples were tested unofficially or as a trial analysis until desired test results obtained. Data fabrication and data discarding: Original raw data and records were altered for e.g., by using of correction fluid or Manipulation of a poorl
Pharma API-Useful Links: APIC guidelines series_Regulatory starting material APIC POSITION PAPER ON THE DEFINITION OF ACTIVE SUBSTANCE CEFIC/APIC Position on Post-Approval Change Authorization Procedures (PACAPs) relating to the manufacture of APIs CEFIC/APIC Position on the “Procedure for the Certification of Suitability to the Monographs of the European Pharmacopoeia” (CEP Procedure) versus the “Drug Master File Procedure” (DMF Procedure) Need for GMP for API production Process Validation: General Principles and Practices -USFDA European Medicines Agencies-Guideline on the chemistry of active substances Questions and answers on level of detail in the regulatory submissions Questions and Answers on Design Space Verification QbD: A Global Implementation Perspective The EU Perspective