Good Manufacturing Processes
What is our biggest source of GMP failures and contamination on the floor?
When you arrive on site and pass through security, what is the first thing you should do?
Drop your lunch off at the lunch room before getting dressed.
What must be worn in loud areas?
Earplugs/hearing protection
What is your responsibility with regards to documentation?
To ensure that data integrity is maintained, records are complete, contemporaneous, and truthful.
What are value added activities?
Things that we want to maximize:
- filling cartridges
- labeling cartridges
- inspection
How do we ensure sterility when manufacturing our drug products?
By following our SOP processes (and not deviating from our written procedures).
After going to the washroom, what must you do?
Wash your hands
What is the rule regarding gum, food, or water?
There is zero tolerance. No food on the production floor!
What is the proper way to make corrections?
Make a single line through the mistake, add a symbol (the number with a circle), make the correction, add a note with the reason for the mistake, initial and date.
What are non-value added activities?
Things that we want to eliminate:
- unplanned downtime
- unplanned maintenance
- rework due to error
What is contamination?
When handling glass, what must you wear?
Cut resistant gloves
As a visitor, what must you wear?
A lab coat, hairnet, maybe a beard net, shoe covers, safety goggles.
If you have to perform a calculation, what is the rule for rounding?
Do not round until the calculation is complete.
What is speed loss?
Time loss due to the machine stopping and starting or not running at full speed.
What does SISPQ stand for?
Safety, Identity, Strength, Purity, Quality
If you take medicine that can make you feel drowsy or if you feel ill, what must you do?
Notify your supervisor
What must an operator wear?
Site wear, hair net, beard net, safety shoes, safety glasses
What does ALCOA stand for?
Attributable, Legible, Contemporaneous, Original, Accurate
What is quality loss?
Quality loss is time spent producing product that is no good and therefore cannot be sold.
Why does GMP matter?
GMP mitigates risk and enables us to produce a good quality product EVERY time.
GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This protects the consumer from purchasing a product which is not effective or even dangerous.
If you have to leave the building during your shift (smoke break, etc.) what must you do?
Change out of your site wear and into your street clothes.
What must not be worn on the production floor?
Jewelry, makeup, fake nails, etc.
Why does ALCOA matter?
It provides us with a mental checklist that ensures that we have data integrity.
What is OEE?
OEE is a metric for producing good product at full speed.