GMP quiz

Question 1 of 20

1

Who is responsible for Quality and GMP in the University of Manchester cleanroom facility?

Select one of the following:

Quality Assurance Manager
Qualified Person (QP)
Professor Sue Kimber
Production Manager
Everyone who works in this area

Explanation

Question 2 of 20

1

What is the abbreviation IMP used for?

Select one of the following:

Inner Membrane Protein
Inosine Monophosphate
Investigational Medicinal Product

Explanation

Question 3 of 20

1

How do you ascertain that a piece of equipment in the cleanroom is ready for use?

Select one of the following:

Review its cleaning record
Review its calibration record/status
Review its validation record/status
Review its performance qualification
All of the above

Explanation

Question 4 of 20

1

The definition of GMP is ‘a quality system (a) - - - - - - - that products are (b) - - - - - - - - manufactured to a (c) - - - - - - - appropriate to their intended use’.

Select one of the following:

(a) assuring, (b) correctly, (c) system
(a) ensuring, (b) consistently, (c) quality
(a) checking, (b) properly, (c) scheme

Explanation

Question 5 of 20

1

The drug which made a large contribution to the necessity to set up the Medicines Act was Thalidomide. True or false?

Select one of the following:

True
False

Explanation

Question 6 of 20

1

The primary concern of the MHRA and other regulators is to ensure .......

Select one of the following:

that they visit every pharmaceutical manufacturer once a year.
that foreign drugs do not enter the UK market.
patient safety.
that they thoroughly check all manufacturing and cleaning records.

Explanation

Question 7 of 20

1

Quality Risk Management is described in ....

Select one of the following:

ICH guideline Q9
ICH guideline Q2
ICH guideline Q8

Explanation

Question 8 of 20

1

If you make an error when entering information on to a GMP document, what should you do?

Select one of the following:

Use Tippex to erase the entry, then write on top of it once dry.
Use pencil for all entries so you can easily rub it out and re-write it.
Use a single line to cross through the original entry, then enter the correct information as close as possible to the original entry. Sign and date the amendment with a brief explanation for the change.
Use a line of crosses so the original entry can no longer be seen, then enter the correct information as close as possible to the original entry, sign and date this change.

Explanation

Question 9 of 20

1

What should happen to rejected materials?

Select one of the following:

They should be put in a suitable waste bin as soon as possible.
They should be labelled as rejected and stored with other materials.
They should be clearly labelled as rejected and stored separately in a restricted area.
They should be saved and used as material in experimental work.

Explanation

Question 10 of 20

1

For GMP outsourcing, what documentation must be in place between a contract giver and contract acceptor, e.g. for contract manufacturing or analysis?

Select one of the following:

All the information necessary to manufacture or test in accordance with the Marketing Authorisation, CTA or IND.
A fully signed contract between both parties.
A technical/quality agreement.
A list of responsibilities.
All of the above.

Explanation

Question 11 of 20

1

If you have an approved recall SOP, it is not necessary to test your recall process. True or false?

Select one of the following:

True
False

Explanation

Question 12 of 20

1

A 30 page batch manufacturing record must include the batch number on every page. True or false?

Select one of the following:

True
False

Explanation

Question 13 of 20

1

If you record a weight using a thermal printer and this is securely attached to the batch manufacturing record, it is not necessary to perform any further action. True or false?

Select one of the following:

True
False

Explanation

Question 14 of 20

1

How long should it take to fully sign off a deviation?

Select one of the following:

One week
3 months
28 days
48 hours

Explanation

Question 15 of 20

1

Following GMP is guidance. True or false?

Select one of the following:

True
False

Explanation

Question 16 of 20

1

Who can release a pharmaceutical product for use in a clinical trial?

Select one of the following:

The principal investigator of the clinical trial.
The Quality Assurance (QA) Manager.
A Qualified Person (QP).
The university professor responsible for the clinical trial.

Explanation

Question 17 of 20

3

What types of licence may be required for working in the University of Manchester cleanroom facility?

Select one or more of the following:

Human Tissue Authority (HTA) licence.
MHRA Manufacturer Investigational Medicinal Products (MIAIMP).
MHRA Wholesale Dealer Licence (WL).
Human Fertilisation and Embryology Authority (HFEA) Research Licence.

Explanation

Question 18 of 20

1

A GMP requirement for Quality Control (QC) is .......

Select one of the following:

test methods are the latest available.
testing methods are environmentally friendly.
test methods are validated.

Explanation

Question 19 of 20

1

GMP stands for Good Medicines Practice. True or false?

Select one of the following:

True
False

Explanation

Question 20 of 20

2

A Quality Risk Management System should ensure that .......

Select one or more of the following:

the evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient.
the level of effort, formality and documentation of the quality risk management process is commensurate with the level of risk.
it effectively replaces direct communications between industry and regulators.
All of the above.

	Created by Joan Benson almost 10 years ago

A quiz to test GMP knowledge

Question 1 of 20

Who is responsible for Quality and GMP in the University of Manchester cleanroom facility?

Select one of the following:

Explanation

Question 2 of 20

What is the abbreviation IMP used for?

Select one of the following:

Explanation

Question 3 of 20

How do you ascertain that a piece of equipment in the cleanroom is ready for use?

Select one of the following:

Explanation

Question 4 of 20

The definition of GMP is ‘a quality system (a) - - - - - - - that products are (b) - - - - - - - - manufactured to a (c) - - - - - - - appropriate to their intended use’.

Select one of the following:

Explanation

Question 5 of 20

The drug which made a large contribution to the necessity to set up the Medicines Act was Thalidomide. True or false?

Select one of the following:

Explanation

Question 6 of 20

The primary concern of the MHRA and other regulators is to ensure .......

Select one of the following:

Explanation

Question 7 of 20

Quality Risk Management is described in ....

Select one of the following:

Explanation

Question 8 of 20

If you make an error when entering information on to a GMP document, what should you do?

Select one of the following:

Explanation

Question 9 of 20

What should happen to rejected materials?

Select one of the following:

Explanation

Question 10 of 20

For GMP outsourcing, what documentation must be in place between a contract giver and contract acceptor, e.g. for contract manufacturing or analysis?

Select one of the following:

Explanation

Question 11 of 20

If you have an approved recall SOP, it is not necessary to test your recall process. True or false?

Select one of the following:

Explanation

Question 12 of 20

A 30 page batch manufacturing record must include the batch number on every page. True or false?

Select one of the following:

Explanation

Question 13 of 20

If you record a weight using a thermal printer and this is securely attached to the batch manufacturing record, it is not necessary to perform any further action. True or false?

Select one of the following:

Explanation

Question 14 of 20

How long should it take to fully sign off a deviation?

Select one of the following:

Explanation

Question 15 of 20

Following GMP is guidance. True or false?

Select one of the following:

Explanation

Question 16 of 20

Who can release a pharmaceutical product for use in a clinical trial?

Select one of the following:

Explanation

Question 17 of 20

What types of licence may be required for working in the University of Manchester cleanroom facility?

Select one or more of the following:

Explanation

Question 18 of 20

A GMP requirement for Quality Control (QC) is .......

Select one of the following:

Explanation

Question 19 of 20

GMP stands for Good Medicines Practice. True or false?

Select one of the following:

Explanation

Question 20 of 20

A Quality Risk Management System should ensure that .......