It's time to think beyond enforcement actions. It's time to think more than profit & loss. It's time to succeed more than only success.
Sometimes we have to break our own boundaries.
If you will try to find out the WLs given for violation of "1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192)."
You will find that there are 131 observations & 131 Warning Letters issued to different pharmaceutical Industries.
Out of those 17 are issued in 2022.
I have discussed with you this observation many times. Today again I am writing about this.
Let me ask you one question that most of us might have read this observation many times. Then why this is found again & again in WLs?
Most of the people working in Quality & others from the Pharmaceutical Industries might have read section 21 CFR 211.192 then why the one is not able to see the gap in its implementation?
One of the common reasons is;
1. The study has not been extended to other batches which are impacted by this non-compliance. (WL #629019)
2. The firm failed to investigate out-of-specification (OOS) assay results for several lots of topical over-the-counter (OTC) drug products. (MARCS-CMS 618333)
3. The firm failed to adequately investigate out-of-specification (OOS) laboratory results and unexplained discrepancies.
Your investigation into the cross-contamination of 22 lots of Pain Aid Extra Strength (ESF) tablets with the active pharmaceutical ingredient (API) guaifenesin, which is not part of the ESF formulation, failed to scientifically identify the root cause of the contamination. Instead of investigating each OOS result, your firm compiled all the OOS results into one investigation, which resulted in no corrective action and preventive action (CAPA). Your firm then proceeded to modify the approved analytical method TM-48A to retest new sample preparations. Your retesting also produced failing test results for guaifenesin cross-contamination. When you did not obtain favorable results, your firm then used a new and unvalidated test method, TM-149, to test only the failed samples, obtained passing results, and subsequently released the drug product lots for distribution.(Warning Letter 624650)
What do you think, what can be the other reason?
Don't you think that time has come to think beyond enforcement actions?
Why audit is required to manufacture a drug of good quality?
For any company why anyone else is required to ensure that the company is manufacturing good quality medicines?
Think about this...
Read the book "Blue Ocean of Compliance" and you will get many new insights to bring changes in the ways you look the things on your site.