Flight_19 Write up on CAPA in Stocktwits

In Stocktwits, Flight_19 has said that he works as an auditor and is very familiar with FDA type Audits. He said he would try to provide an understanding of this field in installments. So he has begun to do this on Stocktwits, but that format does not provide the best medium, but that is where he will do it.

So, I have chosen to consolidate his posts today into one long one on Reddit and as he provides updates, I will either update this or will create new posts. Thank you Flight_19 for doing this.

10/18/22

MGK (deep respect for) has requested I provide an explanation for what is CAPA? I won’t be able to condense this explanation to one post and make it clear and easy (I hope) to follow and a result will have a few installments. I’m currently doing audits in the EU and my responses will be slow, so if anyone has any questions I’m here to answer in time 😊

Part 1: CAPA is a GxP acronym for Corrective and Preventive Actions. CAPA in the FDAs opinion is a foundational tool, in fact the most important to both GCP and GMP processes. The purpose of the corrective and preventive action subsystem is to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence.

Part 2: Verifying or validating corrective and preventive actions, communicating corrective and preventive action activities to responsible people, providing relevant information for management review, and documenting these activities are essential in dealing effectively with product and quality problems, preventing their recurrence, and preventing or minimizing device failures. One of the most important quality system elements is the corrective and preventive action subsystem. CAPAs are graded in severity using industry standard descriptions of Critical, Major, Minor, and Recommendations. Often Minor and Recommendations don’t require much effort from the company. Critical and Major issues do require significant effort to resolve and can take over a year in a worst case scenario.

Part 3: How does CAPA relate to the CYDY Quality System? First off, I must note that I have no understanding of CYDYs QS or how extensive their QS is. A complete QS can contain 200-700+ Standard Operating Procedures, Work Instructions and Policies based upon the complexity of the drug, device, or drug +device. When the internal and external audits occur, the audit report includes the deficiencies (aka gaps, problems, issues, events, etc.) that have been identified AGAINST the regulations I’ve noted previously (as a reminder: 21 CFRs and ICH). FDA (per MGK - the enforcer) uses what they term a “risk-based approach” where the more egregious the deficiency, the more effort the company must show to the enforcer what steps they have taken to correct, prevent and de-risk the event. The goal is to prevent recurrence!

Part 4: This ‘evidence’ the enforcer will ask to see is not a simple few paragraphs…it’s a compilation of documentation (can be 100s of pages on ONE issue) that answers three (3) bullet points any enforcer will ask: 1) Say what you do (e.g. are there a set of company instructions that describe to the enforcer what steps they must follow? These are commonly called SOPs or Standard Operating Procedures) 2) Do what you say (e.g. did the company prove to the enforcer they followed the set of instructions?) 3) Prove it! (e.g. does adequate evidence exist to VERIFY to the enforcer the steps taken correct the problem?). Remember, if it wasn’t written down it NEVER happened (GDPs = Good Documentation Practices)

Part 5: Can open CAPAs prevent a company from filing? Yes, absolutely! If the company has more than one occurrence of the issue, a significant number of Major or Critical CAPAs, the Quality System is (most likely) not functioning as designed and can result in a CRL, a RTF, a warning letter, or a consent decree based upon the seriousness (Risk-based) of the issue. How long does a CAPA take to close? This is the most common question and is similar to asking someone how long their shoes last. There are many factors that can affect closure and until the closure of serious CAPAs occur the organization is basically dead in the water. What is important to note here, is a CAPA must go through a phase known as “Verification of Effectiveness” or an “Effectiveness Check”. This phase verifies the CAPA was effective by using a company defined algorithm to selectively sample the deficient output(s) and confirm the event did not recur.

Part 6: One other point to note: The internal audits and external audits performed on or by CYDY cannot be reviewed by FDA or any other regulatory agency. These are off limits and to state the obvious, we would never be privy to any of these findings as shareholders. I hope this makes some sense to this board 😊 📷Bullish