QUESTION $26$

A marketing authorisation $($MA$)$ includes which of the following?

a$.$

Quality system

b$.$

In$-$Process controls

c$.$

Personnel requirements

d$.$

Records

$2$ points

QUESTION $27$

Which of the following is not true with respect to continuous improvement

a$.$

Mainly small improvements less likely to require major capital investment

b$.$

Makes changes that are generally easier to implement

c$.$

Requires experts who have a range of quality tools at their disposal

d$.$

The ideas come from the workers themselves

$2$ points

QUESTION $28$

Poka yoke can assist in process development through

a$.$

All of these

b$.$

Eliminating rework

c$.$

Reducing variability so products are consistent

d$.$

Eliminating mistakes and errors in any process

$2$ points

QUESTION $29$

Examine the following definition

A deficiency which has produced, or leads to a significant risk of producing either a product which is harmful to the human or veterinary patient

If you were auditing a pharmaceutical site and found such a defeciency, which classification would it be$?$

major deficiency

minor deficiency

critical deficiency

none of the others

$2$ points

QUESTION $30$

According to ICH Q$10,$ to implement and maintain the pharmaceutical quality system and continually improve its effectiveness, organisations should:$-$

a$.$

determine and prioritise quality projects for significant step changes

b$.$

determine and develop key individuals as quality champions

c$.$

determine and establish procedures for structured improvement programmes

d$.$

determine and provide adequate and appropriate resources

$2$ points

QUESTION $31$

Incidents must be formally reported by a QP

a$.$

False

b$.$

True

$2$ points

QUESTION $32$

What is the minimum proving standard for a cleaning validation?

$2$ consecutive cleaning applications

$3$ consecutive cleaning applications

$4$ consecutive cleaning applications

$5$ consecutive cleaning applications

$2$ points

QUESTION $33$

A clinical trial conducted according to a single protocol at more than one study centre is called a

a$.$

Multi$-$investigator study

b$.$

None of these

c$.$

Multi$-$country study

d$.$

Multi$-$ centre study

$2$ points

QUESTION $34$

For a Licensed Product, a widening of the specification would be regarded as a Major change

a$.$

False

b$.$

True

$2$ points

QUESTION $35$

Continuous improvement is

a$.$

Based on small changes to enhance performance

b$.$

A Kaizen blitz day every month

c$.$

A team building exercise

d$.$

Looking for radical break through enhancements

$2$ points

QUESTION $36$

When a company awards a contract to an external, outsourced company which of the following is not true?

The Contract Giver is responsible for assessing the legality, suitability and the competence of the Contract Acceptor

The Contract Giver should monitor and review the performance of the Contract Acceptor

The Contract Acceptor may subcontract to a third party without the Contract Giver$$s approval

The Contract Acceptor should ensure that all products, materials and knowledge provided are suitable for their intended purpose

$2$ points

QUESTION $37$

Which of the following would not be found in the Product Specification File?

a$.$

Quality Control testing

b$.$

Shipping details

c$.$

Trial methodology

d$.$

Packaging detail

$2$ points

QUESTION $38$

Which of these is used to test the transportation packaging and routes for pharmaceutical distribution?

transport verification

transport validation

transport qualification

transport monitoring

$2$ points

QUESTION $39$

The process where a marketed product is placed inside an empty capsule shell and filled with an inert filler to produce a blinded IMP is called

a$.$

None of these

b$.$

Over$-$encapsulation

c$.$

Double dummy manufacture

d$.$

Capsulation

$2$ points

QUESTION $40$

Records provide

a$.$

evidence of actions taken

b$.$

All of these

c$.$

demonstrate compliance with instructions

d$.$

raw data

$2$ points

QUESTION $41$

Which of these is a disadvantage of active cooling systems used in cold chain logistics to maintain temperature control?

Refrigerant must be conditioned according to spec

Longer pack out times

Cannot be shipped to all destinations

not very secure

$2$ points

QUESTION $42$

The starting point for problem solving is

a$.$

To prioritise the best solutions

b$.$

To discover all the causes of the problem

c$.$

To define the problem effect clearly

d$.$

To eliminate erroneous data

$2$ points

QUESTION $43$

Incidents non$-$conformities or deviations should be reported;

a$.$

At the time of the event by anyone

b$.$

To the medicines ins