Deviation & Failure Case Studies – Page 9

PPQ acceptance criteria changed post hoc during requalification – inspection outcome explained

The initial indication of a potential issue arose during the routine inspection following the requalification of a critical manufacturing equipment set. Team members noted discrepancies between the expected output and…

PPQ acceptance criteria changed post hoc during requalification – CAPA and revalidation failure

The initial signs of the deviation were observed during the requalification of a mammalian cell culture process. Quality Control (QC) flagged discrepancies when results from the most recent Performance Qualification…

Inadequate worst-case justification during validation lifecycle – regulatory deficiency case study

Early detection of symptoms related to inadequate worst-case justification is essential for timely action. The key indicators in this scenario included:Click to read the full article.

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

In a mid-sized pharmaceutical manufacturing company, quality assurance (QA) personnel discovered discrepancies between the expected and actual output of batch records generated by a newly validated computerized system. The symptoms…

Inadequate worst-case justification during inspection readiness – regulatory deficiency case study

During a routine FDA inspection, an auditor flagged deficiencies related to risk assessment documentation associated with a new manufacturing line for a sterile injectable product. Specifically, the inspector noted that…

Validation protocol deviation ignored during change control – CAPA and revalidation failure

During a routine performance review of a sterile manufacturing facility, operators noticed discrepancies in the expected yield of a critical drug product. Symptoms included:Click to read the full article.

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…

Serialization mismatch detected during deviation review – CAPA ineffectiveness analysis

The initial detection of the serialization mismatch occurred during the quality control (QC) department's routine review of batch records. Key indicators included:Click to read the full article.

Serialization mismatch detected during inspection – recall risk case study

The first indication of a potential issue began with the Quality Control (QC) department, which noted irregularities in the serialization data logs during a product release review. Several batches exhibited…

Line clearance failure causing mix-up during artwork change – recall risk case study

During a routine quality check, team members identified discrepancies in product labeling following a scheduled changeover in production lines. Employees reported that several batches of products bore incorrect labeling for…