cGMP
cGMP is an acronym. What does is stand for?
Current Good Manufacturing Practice(s) (cGMPs)
The sterilization indicator on gamma irradiated materials is this color if it has been successfully sterilized.
What is red?
The first thing that should be performed after entering a Grade A room and waiting for the air stabilize.
What is sanitizing your gloves?
The purpose of sanitizing gloves after touching non-product contact items that have been previously sanitized.
What is preventing cross contamination? Non-product contact parts are often touched by multiple personnel and are not sterilized. Sanitizing gloves and or the non-product contact item will only reduce contamination, not sterilize the material.
Demonstrate the proper method to sanitize gloves in the Grade A/B area.
Demonstration must include contact with the following areas:
Palms, back of hands, fingers, between fingers, wrist, forearms and fingertips
Regulations enforced by the FDA to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.
What are cGMPs?
How many CFUs (colony forming units) are allowed in the Grade A processing area on sampled surfaces (ex. furniture, equipment & fingers)?
ZERO CFUs are allowed! NO GROWTH!!!! (Making a sterile product!)
Where should hands be held while working in the Grade A area?
Hands should be held above the waist and elbows
Contact time for this sanitant is validated for 30 seconds in order to be effective at reducing bacterial based organisms in the classified areas.
What is 70% IPA (alcohol)?
Walking in a Grade A room
Demonstration should be slow and purposeful with hands held above the waist and elbows
The result of violating cGMPs during an inspection such as:
can result in this.
What is a Form 483 violation? (other answers include a recall (voluntarily or per FDA request), Public warning and drug seizure through the court process. 483's can result in a Warning Letter from the FDA agency)
The process of taking samples of the area surrounding the aseptic process.
What is environmental monitoring?
The process where clean room personnel have full control over gowning excursions (assuming garments have been processed correctly by the vendor).
What is gowning? (should be performed in a controlled manner to prevent contamination. Avoid contacting the outside of sterile garments with non-sterile surfaces)
Obtaining an environmental monitoring sample while sanitization activities are occurring, usually result in this due to the creation of a false positive result.
What is a deviation?
Demonstrate the method for using a cleanroom telephone or touch screen in the aseptic processing area.
Use of knuckle
The internal GMP audit finding received in earlier this year was based around this process which was also identified to be the direct cause for cross contamination between classified areas.
What is the Material Transfer Process (from Grade C to B)?
This must be checked prior to use of sterilized materials, in conjunction with package integrity, to ensure the material is in fact sterile.
What is an expiration date?
The local document number which governs aseptic conduct and technique in the aseptic core and classified areas.
What is 203716?
The substance used to eliminate spore former organisms in the classified areas.
What is Spor-klenz? (sporicidal agent)
Proper sanitization method for sanitizing surfaces such as table tops, walls and floors. Demonstrate the technique.
Per procedure 032004
Table tops & Walls: overlapping strokes (typically by 20% from top to bottom or left to right)
Floors: S movements
This entity is responsible for protecting the public health by assuring the safety, efficacy, and security of human drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. They also provide accurate, science-based health information to the public.
Who is the F.D.A. (Food and Drug Administration)
The process of simulating aseptic activities and validating processing times. This is to ensure successful production activities can take place in the cleanroom environment, free of contamination.
What are media fills (aseptic process simulations; APS)?
The only time you are prohibited from sanitizing gloves/forearms during aseptic production.
What is prior to performing personnel monitoring?
FDA Guidance for Industry 2004 page 15 of 59: Sanitizing gloves just prior to sampling is inappropriate because it can prevent recovery of microorganisms that were present during an aseptic manipulation.
Breaking this barrier over critical surfaces may result in discarding product.
What is first air?
You are working in the aseptic core area and sneeze into your sterile mask. Demonstrate/explain the proper order for changing out the face mask (high level).
In short:
1. Remove goggles
2. Remove facemask
3. Don new sterile facemask
4. Don new sterile goggles
5. Remove outer gloves
6. Don new pair of sterile gloves