Validation & Qualification Deviations – Page 5

PPQ acceptance criteria changed post hoc during requalification – regulatory deficiency case study

The initial signs of deviation within the organization began during the requalification of a critical production line, essential for the manufacture of a monoclonal antibody product. Quality Control (QC) technicians…

PPQ acceptance criteria changed post hoc during change control – regulatory deficiency case study

During a routine FDA inspection, it was discovered that the acceptance criteria for a specific PPQ batch had been altered without appropriate documentation or approval. This anomaly surfaced when production…

CSV not aligned with actual use during requalification – regulatory deficiency case study

The initial detection of the CSV misalignment emerged from an internal audit shortly before a scheduled regulatory inspection. Observers noted discrepancies between validation documentation and actual operational workflows. Key symptoms…