Good Manufacturing Processes
What is our biggest source of GMP failures and contamination on the floor?
It is ok to use white out and scribbles when fixing an error
No, NEVER!
What is the proper way to write a time down?
HH:MM
24 Hour clock. AM and PM is not required.
What is your responsibility with regards to documentation?
To ensure that data integrity is maintained, records are complete, contemporaneous, and truthful.
What does "smh" stand for?
Shaking my Head
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 proper way to write the date?
DD-MMM-YYY
Remember the correct short form of the months. Always write 2 digit day and 4 digit year.
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 rapper is besties with Martha Stewart
Snoop Dogg
What is contamination?
When filling out a section of the batch record you notice a blank space on the page. Should you date and initial to avoid having a blank? Why or why not?
You should only initial an action that you personally completed. If you did not complete the action you should escalate to your leader.
Once you sign for something you are taking responsibility.
Blank spaces are ok and should just be left as is?
Blank spaces are never ok. If the same is not needed it should be N/A'd.
If you are writing the same thing over and over again, you are able to use "ditto marks" or an arrow to capture the information.
No. This is never allowed. you must re-write the date, time and your initials for everything that is entered every time.
What American Actress is married to Prince Harry
Meghan Markle
True or false: GMP compliance is the same as ISO compliance?
False.
ISO is NOT A legal requirement
ISO and GMP do contain similar requirements, but they are not the same.
NEVER! If you do write something on an un-official document you must now keep that paper or cardboard and you must write the batch number, and initial and date it.
When fixing an error the symbol you use can be anything you want?
No. The symbol should be a number in numerical order with other errors on the page.
What does ALCOA stand for?
Attributable, Legible, Contemporaneous, Original, Accurate
What Medical drama, that started in the 2000's, is still on TV today?
Grey's Anatomy
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.
Highlighters and markers are fine to use in the logbooks and batch records? Why or why not?
Never. Markers and highlighters are not allowed. They can smudge or run and make the documents illegible.
It is ok to fix partial entries if only 1 number or portion are incorrect? i.e.: day is incorrect, but month and year are fine or 1 number is wrong, but the rest are correct?
NO. The entire entry must be crossed out and re-written with the proper information.
Why does ALCOA matter?
It provides us with a mental checklist that ensures that we have data integrity.
YouTube was created in what year?
2005