Deviation & Failure Case Studies – Page 8

Inadequate worst-case justification during change control – regulatory deficiency case study

During routine quality checks, a pharmaceutical manufacturer discovered discrepancies in the change control documentation related to a new packaging material. Upon review, it became evident that the justification for potential…

Process validation not repeated after change during validation lifecycle – CAPA and revalidation failure

The initial indication of a potential problem arose when consistent discrepancies were noted in batch yields during the production of a sterile injectable product. Operators observed that yield percentages varied…

Process validation not repeated after change during requalification – regulatory deficiency case study

During a routine internal quality audit at the facility, several anomalies were observed:Click to read the full article.

Process validation not repeated after change during change control – inspection outcome explained

In our case study at a mid-sized pharmaceutical manufacturing plant, the first signs of a significant issue arose during routine batch record reviews. Operators noted a rise in out-of-specification (OOS)…

Requalification overdue during inspection readiness – CAPA and revalidation failure

The initial triggering event for this case study was identified during an internal audit, where it was revealed that multiple assets, primarily critical manufacturing equipment, were significantly overdue for their…

CSV not aligned with actual use during validation lifecycle – CAPA and revalidation failure

During routine quality checks, a manufacturing facility observed discrepancies between the data output from their validated software and the actual production results. The symptoms that prompted an internal investigation included:Click…

Requalification overdue during validation lifecycle – CAPA and revalidation failure

In the case of a mid-sized pharmaceutical manufacturing facility, personnel noticed a consistent uptick in deviations reported during the quality check of a production batch. The inspections revealed that several…

Equipment qualification incomplete during change control – regulatory deficiency case study

Case Study of Regulatory Deficiency Due to Incomplete Equipment Qualification During Change Control In the pharmaceutical landscape, maintaining compliance with Good Manufacturing Practices (GMP) is critical for ensuring product quality…

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

The initial detection of the issue arose when discrepancies were noted between the PPQ acceptance criteria established during the validation lifecycle and those utilized during production runs. The symptoms surfaced…

Requalification overdue during validation lifecycle – regulatory deficiency case study

During a routine internal inspection, a QA team discovered that the calibration and requalification of a critical piece of manufacturing equipment had lapsed by several months. The symptoms noted included:Click…

Inadequate worst-case justification during change control – inspection outcome explained

During a routine internal audit, quality assurance (QA) personnel identified discrepancies in the justification documentation for a significant change proposal related to a critical manufacturing process. The primary symptoms observed…

Equipment qualification incomplete during validation lifecycle – inspection outcome explained

During an internal audit, several issues were flagged indicating incomplete equipment qualification. Symptoms included:Click to read the full article.