cGMP - Process Steps Knowledge Check (Module 3) Rev 1

True or False: My pipette does not have a calibration label; but it works! I can go ahead and use it for a verification/validation (V/V) build.

True

False

A lot of Colloidal Gold LN W22-0103 failed the OD specification. What form do I need to use to capture the failed lot?

National Center for Marine Research

National Conference on Manufacturing Research

Non-Conforming Material Report

Non-Combustible Materials Rulebook

If you have to take alternative steps to the ones prescribed in a procedure, what is that called?

Deviation

Divergence

Departure

Difference

Where can you find the Deviation form and procedure?

S:\Document Library - Approved\000-299_Quality Systems\018 Quality Planning Procedure

S:\Document Library - Approved\000-299_Quality Systems\008 Deviation Procedure

S:\Document Library - Approved\000-299_Quality Systems\028 Nonconformance Log Shortcut

S:\Document Library - Approved\000-299_Quality Systems\002 Good Manufacturing Practices (GMP)

True or False: Line clearance is only recommended if you are performing manufacturing more than two different lots at a time

True

False

I am 2 milliliters short XYZ reagent with LN-2244LMN. However, there's 2 milliliters left over from LN-1234QRS. To make sure we aren't wasting product, it's ok to mix the lot numbers in order to complete the batch?

Yes, it's ok! Better to do that than to waste product

No, we don't mix lots. This is important for traceability

True or False: Using equipment past expiry/calibration is ok as long as it performs as expected

True

False

What is the best time for me to fill out the Bill of Materials (BOM) listed on the work instructions I am using?

Anytime is fine, just make sure you complete the BOM at some point

Complete the BOM at the end once you know what you used

Always complete the BOM before you start any work to make sure you have enough product

Filling out the BOM is not required most of the time

It's not necessary to record work you are doing AS you are doing it?

You can record it when you are finished as long as you have a good memory

You need to record work you are doing AS you are doing it

As long as it's recorded, you're ok

Don't worry about it. Auditors don't check this

cGMP - Process Steps Knowledge Check (Module 3) Rev 1_13SEP2022