Only correcting the existing mistake do not suffice. You must think beyond this.......

Let's discuss the new case study : Warning Letter 320-23-04

Observation was given because firm's investigations into rejected batches failed to extend to other batches, dosage strengths, and drug products for tablet compression machine settings.

From 2018 to 2021, firm rejected 14 batches of tablets for out-of-specification (OOS) results for (b)(4) and content uniformity results. Firm implemented additional stratified sampling and conducted engineering batches to simulate the root cause for the failures for both dosage strengths.

Although the firm attributed the content uniformity failure to the lack of defined compression parameters for batches, but failed to test other batches or drug products that used the same (b)(4) process and compression equipment.

The firm given the response, firm acknowledged batches were rejected for the batches of tablets and that firm did not apply the corrective actions for the compression parameters for firm's other strength tablets. As a result of this inspection, firm conducted a retrospective review and discovered a failing stratified sample assay result for other strength batches and initiated a voluntary recall of those batches. However, firm's response did not adequately address the firm’s failure to investigate the assay failure and market impact at the time of its occurrence and it did not include an overall management strategy for improving all phases of firm's investigations.

In response to this letter, Authority asked to provide the following:

• A comprehensive independent assessment of the overall system for investigating deviations, discrepancies, complaints, OOS results, and failures.
• To provide a detailed action plan to remediate this system to include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, corrective action and preventive action (CAPA) effectiveness, quality oversight, and written procedures.
• Address how the firm will ensure that all phases of investigations are appropriately conducted.
• An independent assessment and remediation plan for the CAPA program.
• To provide a report that evaluates whether the program includes effective root cause analysis, ensures CAPA effectiveness, analyzes investigations trends, improves the CAPA program when needed, implements final quality assurance decisions, and is fully supported by executive management.