There are thousands of pharmaceutical industries in the world.
All manufacture the medicines. But the purpose of different companies are different.
And hence the thought process of working all the companies are very different.
And hence the purpose for preparation of an audit is also very different.
Few work only for commercial benefits for the company.
Few work to pass the audit to save their jobs.
Few work for patient.
Few work to be the best.
Few only want to pretend to be the best.
Few work to qualify the audit to get the new business opportunity.
Few work to manufacture medicines for cause.
So based on the purpose the way of thinking, the way of taking actions, the strategy for audit everything is different. So efforts to qualify the audits & result of audit is also different for different people & different companies.
Analyse & conclude that what is your reason for preparation of an audit as a person & as an entrepreneur.
As per the title company got an observation due to the non-compliance due to the violation of (21 CFR 211.192) section.
The reason for that was following;
Firm's investigations into rejected batches failed to extend to other batches, dosage strengths, and drug products for tablet compression machine settings.
This is very common reason found because of which many companies got warning letter that investigation was not extended to other batches.
From 2018 to 2021, firm rejected 14 batches of few 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 firm attributed the content uniformity failure to the lack of defined compression parameters for the batches of one strength, firm failed to test other batches or drug products that used the same (b)(4) process and compression equipment.
In firm's response, firm acknowledged batches were rejected for the X and Y mg tablets and that you did not apply the corrective actions for the compression parameters for Y mg strength tablets.
As a result of this inspection, you conducted a retrospective review and discovered a failing stratified sample assay result for Y mg tablets batch MNZ and initiated a voluntary recall of this batch on June 10, 2022. However, the response did not adequately address 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 your investigations.
Study in your site that whether you have any non-compliance of this type on your site & if so take actions to remove that cause.