Who is responsible for Quality and GMP in the University of Manchester cleanroom facility?
Quality Assurance Manager
Qualified Person (QP)
Professor Sue Kimber
Production Manager
Everyone who works in this area
What is the abbreviation IMP used for?
Inner Membrane Protein
Inosine Monophosphate
Investigational Medicinal Product
How do you ascertain that a piece of equipment in the cleanroom is ready for use?
Review its cleaning record
Review its calibration record/status
Review its validation record/status
Review its performance qualification
All of the above
The definition of GMP is ‘a quality system (a) - - - - - - - that products are (b) - - - - - - - - manufactured to a (c) - - - - - - - appropriate to their intended use’.
(a) assuring, (b) correctly, (c) system
(a) ensuring, (b) consistently, (c) quality
(a) checking, (b) properly, (c) scheme
The drug which made a large contribution to the necessity to set up the Medicines Act was Thalidomide. True or false?
The primary concern of the MHRA and other regulators is to ensure .......
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.
Quality Risk Management is described in ....
ICH guideline Q9
ICH guideline Q2
ICH guideline Q8
If you make an error when entering information on to a GMP document, what should you do?
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.
What should happen to rejected materials?
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.
For GMP outsourcing, what documentation must be in place between a contract giver and contract acceptor, e.g. for contract manufacturing or analysis?
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.
If you have an approved recall SOP, it is not necessary to test your recall process. True or false?
A 30 page batch manufacturing record must include the batch number on every page. True or false?
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?
How long should it take to fully sign off a deviation?
One week
3 months
28 days
48 hours
Following GMP is guidance. True or false?
Who can release a pharmaceutical product for use in a clinical trial?
The principal investigator of the clinical trial.
The Quality Assurance (QA) Manager.
A Qualified Person (QP).
The university professor responsible for the clinical trial.
What types of licence may be required for working in the University of Manchester cleanroom facility?
Human Tissue Authority (HTA) licence.
MHRA Manufacturer Investigational Medicinal Products (MIAIMP).
MHRA Wholesale Dealer Licence (WL).
Human Fertilisation and Embryology Authority (HFEA) Research Licence.
A GMP requirement for Quality Control (QC) is .......
test methods are the latest available.
testing methods are environmentally friendly.
test methods are validated.
GMP stands for Good Medicines Practice. True or false?
A Quality Risk Management System should ensure that .......
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.
