Production and process control is not a difficult section of the QSR to comply with. However, it does take some work scripting procedures that delineate the production process.
Management responsibility is one of the most important requirements delineated in the QSR. If management has no clue as to what is going on in their facility or fails to take appropriate action when serious issues transpire, then just maybe a warning letter isn’t appropriate.
Whenever phrases such as “data falsification” are referenced by FDA in a warning, the offending organization will probably become familiar with the acronym DOJ, as in investigation. Falsifying data that may have resulted in the overall compromising of product safety and efficacy is a serious accusation.
For this week’s journey, Dr. D will attempt to provide a simplified approach for complying with 21 CFR, Part 820.50. Simply stated; “there is no such thing as minimum compliance and no such thing as maximum compliance; there is just compliance.”
Guess what happens if an offending device establishment is awarded with a number of Form 483 observations? If your answer begins with the word “warning” and ends with the word “letter” a.k.a., “warning letter” then you would be correct.
Unannounced audits are now a reality. It is imperative that you work closely with your notified bodies to ensure the transition to unannounced audits is a smooth one.
There are few things in life more frustrating than sitting across from FDA, during an inspection, and not being properly prepared with documented evidence of compliance. If the DHRs are not being properly completed or maintained, rest-assured, the investigator will cite the issue as a Form 483 observation.
Process Validation should be considered one of the basic tenants associated with the manufacturing of finished medical devices that are safe and effective in their intended use. However, what happens when a device establishment fails to implement an effective program for process validation?
If an establishment is manufacturing finished medical devices that are sterile, there should never be any excuses for not properly maintaining and monitoring the cleanroom or CER.
Put significant effort into the design and development planning phase. It really is the road map for a successful design and development process.
