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21.Jun.2013

GMP Multiple Choice Assessment Answers (Questions posted on Linkedin Group 1 June 13)

1) The system of Quality Assurance appropriate for the manufacturer of medicinal products should ensure that:

a – Managerial responsibilities are clearly specified

2) A basic requirement for Good Manufacturing Practice is:

b – Operators are trained to carry out procedures correctly

3) A basic requirement for Quality Control is:

c – Test methods are validated

4) A basic requirement for Quality Control is:

b – No batch is released prior to certification by a quality expert of a suitably Qualified Person

5) The manufacturer must have:

a – An organisation chart

6) The head of production has the responsibility to:

a – Ensure production records are evaluated and signed

7) The head of QC has the responsibility to:

b – Evaluate batch records

8) Personnel should be:

a – Instructed to use the hand washing facilities

9) If a deviation occurs it should be:

b – Approved in writing by a competent person

10) Cross contamination should be avoided by:

c – Using cleaning and decontamination procedures

11) Significant amendments to the manufacturing process:

a – Should be validated

12) If one material delivery is made up of different batches:

b – Each batch must be considered as separate for sampling

13) Starting materials should:

a – Only be dispensed by designated persons

14) When setting up packaging operations:

c – Different products should not be packaged in close proximity

15) Any alterations made to the entry on a document:

b – Must be signed and dated