N/A's
What does N/A mean?
N/A is a common abbreviation used on Batch Records/ any GMP documentation for the phrase not applicable. Meaning this spot is no longer usable.
What colour pens are allowed to be used?
Black and Blue
Are the following symbols allowed to be used when making comments- *, $, @ :)? what must be used instead?
No, numbers
If there is a spot for Yes/No or a check box and you do not use this step it what should you do?
Still needs to be N/A’d as it is expected to be filled out
Where should you start your comments?
Bottom Left hand side of the page
If QA or the PRD documentation reviewers provide you with directions how to make a comment on and error what should one do?
If the directions make sense to the comment one should follow exactly what they have provided. If the comment needs clarification one should escalate it to their team lead or supervisor to get clarity.
Recording the entries before performing the activity or later or backdated is...
Strictly prohibited
What must every comment have?
1. A number circled
2. Write the comment to indicate your error
3. Close off your comment with your initials and date
When reviewing a Batch Record at the end of a batch and there are blank spaces how should one proceed?
A) Leave them blank and let Lawrie correct them
B) N/A all blank spaces
B) N/A all blank spaces
Attachments, printouts etc... must contain?
The Batch number
What are the 4 things QA looks for when commenting a late entry?
1. Stating its a late entry
2. Recording when the event actually took place
3. Providing proof it was completed
4. Writing the current date you are making the comment
If someone has N/A'd a whole page that you actually need what are your next steps?
Contact QA and ask them to reprint the page
Are Omit lines acceptable?
Absolutely not
Can one use the same number and comment as a fellow operator when making a correction?
NO, we must write a new number with a comment to indicate our error with the correction.