The FDA investigators noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing the drug products to be adulterated under section 501(a)(2)(A) of the FDCA.
The investigators observed:
1. Vermin were observed in an area immediately adjacent to the firm’s production area.
2. Production areas were difficult to clean or contain porous, particle generating, or visibly dirty surfaces. Specifically, debris on the floor, peeling tape with an apparent build-up of black residue on the floor in the ISO 7 cleanroom, and black residue build-up around HEPA filters were observed.
3. An operator blocked first air by placing gloved hands directly over open sterile containers.
4. HEPA filters were not sealed around each perimeter to the support frame.
5. Personnel failed to disinfect gloves and components to prevent contamination.
6. Personnel donned gowning apparel improperly in a way that may have caused the gowning apparel to become contaminated.
7. Your firm handled hazardous drug products without providing adequate cleaning of utensils to prevent cross-contamination.
If you had ever been audited any facility very intensively, with a lot of hard work involvement, commitment and ...............
And while discussing those gaps before the auditee you will find the answer that we already know this. Yes, we have noticed that.........
What is special is that we already know it.....
And many other statements.
How you will feel?
What may be your reaction?
Perhaps the same situation might have been raised in this case study.
As the auditor was a regulatory authority he would not have got these statements written above but in heart of the auditee, they might
have whispered these talks?
Do you agree with me?
Whenever we take a round of our facility we also see the gaps. But why do the same observations come in the audit?
Why the actions are taken when the gaps come in the list of the auditor?
Have you ever thought about this?
Try to find the answer to the above question & take action on this.