Compliance Quiz

Who is responsible for compliance at GSIUC?

QA Department

Everyone

Packaging Management

GMP documentation requirements apply to:

a) Paper based systems

b) Electronic based systems

c) All of the above

A “Follow On” CAPA is created when an Observer of an issue is not an Owner/Author of a deviation

a) True

b) False

As per SOP-10320, a Facilitator is the Owner/Author of a deviation.

a) True

b) False

During an investigation, new information arrives on the last day that changes nothing but the classification. If you re-classify and re-route, it will go overdue. Should you:

a) Reclassify and let the deviation go late

b) Raise an extension and get the extension approved

As per SOP-05603, if the inspection results on FRM-11862 (GSIUC Cork QA Finished Product Inspection & Sample Retention Form) have not been completed, it is OK to continue processing the batch.

a) Yes

b) No

It is not acceptable to use the 2D Matrix Verifier under another employee’s login.

a) True

b) False

A trainee is deemed to be fully trained and may complete tasks if the training pack has been signed by the Trainee and Trainer, but not signed by their Manager.

a) True

b) False

In what state must a Form be downloaded from G-Vault for use?

a) Draft

b) Pre-Released

c) Effective

What do you need to do if an original page of a Packaging Batch Record gets damaged and needs to be reprinted?

a) Contact the Packaging Team Lead / Designee to re-print the page.

b) Retain the damaged page

c) Add a comment to the batch record to explain why the re-print was required

d) (a) and (c)

e) All of above

What shoes are permitted to be worn in the packaging area?

a) Transfer shoes

b) Street shoes

c) Safety shoes

d) Any of the above

How many months in a row have Packaging met the QMR metric and been green?

a) 6

b) 17

c) 2

d) 24

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