Deviation & Failure Case Studies – Page 20

Personnel not trained on revised SOP during deviation investigation – CAPA and training system breakdown

The first indicator of a training lapse presented itself when the investigation of a product quality deviation was initiated. Team members tasked with carrying out the investigation were not aware…

Document revisions uncontrolled during audit – CAPA and training system breakdown

The signs of uncontrolled document revisions often surface in various forms. In this particular case, the audit revealed discrepancies between the master batch records and the production documentation. During the…

Backdated training evidence during inspection – QMS remediation failure

The initial signs of trouble manifested during routine internal audits, where Quality Assurance teams reviewed training records against actual training logs. They discovered instances of backdating activities, such as:Click to…

Document revisions uncontrolled during QA review – CAPA and training system breakdown

In our case study, several symptoms indicated a breakdown in the document control process during the QA review. These symptoms included:Click to read the full article.

Training effectiveness not assessed during audit – QMS remediation failure

During a routine internal audit, several symptoms indicated potential gaps in training effectiveness:Click to read the full article.

Document revisions uncontrolled during QA review – QMS remediation failure

Upon receiving a recent audit finding from the FDA, it became evident that several documents in the manufacturing process had been incorrectly revised without proper QA oversight. Key symptoms included:Click…

Backdated training evidence during deviation investigation – CAPA and training system breakdown

The first signals that prompted the investigation began when a batch of a critical injectable product failed to meet quality specifications during routine analysis. A subsequent review of training records…

Training records completed after deviation during QA review – CAPA and training system breakdown

The signs of the training record issue first emerged during a scheduled QA review. The following symptoms were noted:Click to read the full article.

Training effectiveness not assessed during inspection – inspection citation risk explained

PharmaPro experienced several warning signs that culminated in inspection citations. During an FDA inspection, the inspectors noted the following:Click to read the full article.

GDP errors repeated during inspection – CAPA and training system breakdown

During a series of inspections by regulatory authorities, several GDP errors were identified, leading to a non-compliance flag. Key symptoms included:Click to read the full article.

Backdated training evidence during deviation investigation – QMS remediation failure

The situation unfolded when a routine quality control (QC) deviation report highlighted discrepancies in staff training records related to a new manufacturing process. During the audit, several operators reported difficulties…

Document revisions uncontrolled during audit – QMS remediation failure

The first sign of deviation related to document revisions emerged during an internal audit of the Quality Management System (QMS). Auditors noted several critical issues:Click to read the full article.