Every one of Pharma company can understand & should have idea that how much effort, time, energy, manpower should be involved in recalling many batches due to some investigation.
What if all the recalled baches were not impacted batches due to that specific non-compliance & investigation but wrong batches were recalled?
What do you think why this mistake might have happened?
If any company got WL due to some technical issue then it can be understood but what if the recall itself was wrong batches recall.
These instances raises many questions.
By the way due to the above non compliance of not following the 21 CFR 211.192 more than 121 Warning letters have been issued.
Lets discuss one of these;
Case study 1
Observation: Your investigations into water leaks in your cleanroom were inadequate because they lacked appropriate CAPA and failed to extend to other potentially affected batches.
Gap was : Water leaked from the service floor through the heating, ventilation, and air conditioning (HVAC) duct floor and into the ceiling directly above the ISO 5 filling area. The investigation report noted water accumulated on the service floor due to a leak from an old, punctured (b)(4). Water then collected over the (b)(4) partition ceiling prior to entering the aseptic filling room where XYZ injectable suspension USP, was manufactured. There was substantial water accumulation on the service floor.
Investigation & Response given by the company was stated to be inadequate:
Reasons;
1. Although company sealed gaps in the ceiling, but did not sufficiently inspect the service floor, (b)(4) LAF ceiling, and HVAC duct floor for mold growth and water damage after the repairs were made.
2. Failed to extend the scope of the investigation to potentially impacted batches of manufactured in this room since the last preventive maintenance of the (b)(4), approximately two months before the leak was observed.
3.Firm responded that the leak was isolated to the day it was observed. The investigation did not evaluate the impact of the leak to other batches.
4. Firm initiated a recall for all marketed batches manufactured on this line, for events unrelated to this investigation. Pls note that recalled batches were not related to this event.
5.Firm initiated actions to address this specific leak, but its investigation failed to sufficiently address facility damage and the potential for microbial (i.e., particularly fungal) contamination that could persist in the facility due to water leaks and moisture.
Authority Requested for the following;
1.Comprehensive, independent assessment of firm's overall system for investigating deviations, discrepancies, complaints, OOS results, and failures.
2.A detailed action plan to remediate this system. This action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, quality assurance unit oversight, and written procedures. Address how the firm will ensure all phases of investigations are appropriately conducted.