1. The basic elements of a quality management system are:
(A) Focus on an appropriate infrastructure including procedures and processes.
(B) Only an appropriate infrastructure including resources and organizational structure.
(C) An appropriate infrastructure and systematic actions.
(D) Systematic actions and appropriate resources and policies.
2. Quality management is a concept that includes:
(A) Only quality control.
(B) Only quality assurance.
(C) Only GMP and quality control.
(D) Quality assurance, quality control and GMP.
3. Quality assurance includes:
(A) All matters that individually or collectively influence product quality.
(B) Quality management, quality control and GMP.
(C) Only GMP and quality control.
(D) A quality system and quality control.
4. Quality assurance is a:
(A) Narrowly based concept that covers only the administrative arrangements relating to product quality.
(B) Limited activity relating to the product release procedures only.
(C) Wide-ranging concept covering all matters that influences product quality.
(D) Philosophy that gives general guidance only and is issued by top management.
5. Quality assurance is the responsibility of:
(A) The top management of the company only.
(B) Only the staff in the quality control department.
(C) Staff at many different levels and in many different departments across the company.
(D) Only those people who make the product.
6. Good manufacturing practices are directed primarily at:
(A) Ensuring that all products are tested according to specifications.
(B) Ensuring that all products are made in accordance with the formula.
(C) Minimizing risks inherent in production that cannot be prevented thorough testing of finished products.
(D) Preventing cross-contamination only.
7. Quality control is:
(A) Confined to laboratory functions only.
(B) Part of GMP concerned with all the sampling, specifications and testing and the organization, documentation and release procedures to ensure quality.
(C) Dependant on the production department for all its staffing and budgets.
(D) Not required by small manufacturers.
8. Quality control staff:
(A) Do not need to go into production areas because they just test the products.
(B) Have to be independent from production.
(C) Are the only people who can take samples.
(D) Have no other duties than product testing.
9. Records have to be kept of:
(A) Only product testing.
(B) Only product manufacture.
(C) All aspects of all work done demonstrating that the product has been made and tested in accordance with the registered product details.
(D) Only the differences between what is registered and what has been done.
10. Storage and distribution arrangements for the product:
(A) Are not the responsibility of the manufacturer once it has left his factory.
(B) Have no impact on product shelf-life or product quality.
(C) Have to be satisfactory as far as possible throughout the supply chain to ensure quality is maintained.
(D) Is the responsibility of government.
11. Under quality assurance a company should have procedures that:
(A) May be updated before a GMP inspector announces an inspection.
(B) Provide for self-inspection and a quality audit to regularly appraise effectiveness and applicability of the QA system.
(C) Are only written and used by senior management.
(D) Must only be in the language that the GMP inspectors understand.
12. Under GMP a company should investigate complaints:
(A) About marketed products and take appropriate action to prevent reoccurrence of justified complaints.
(B) Only when we know that government may insist on a recall.
(C) Only if the company believes the person making the complaint is truthful and is not just looking for a free replacement.
(D) Only if the production department agrees.
13. A holder of a manufacturing authorization:
(A) Does not need to have a quality control department.
(B) Does not need adequate facilities if he/she has excellent people.
(C) Can confine the quality control department to the laboratory only.
(D) Must provide adequate resources to ensure that all quality control arrangements can be reliably carried out.
14. Products may be sold or distributed:
(A) If requested by the sales director in urgent cases even prior to certification by the authorized person.
(B) Provided QA have done their testing.
(C) Only after certification by an authorized person that the batch has been produced and tested in accordance with the registered product details and any other relevant regulations.
(D) Provided the management responsibilities have been clearly defined in job specifications
15. The system of quality assurance should ensure that:
(A) Management responsibilities are clearly specified in job descriptions.
(B) The finished product is correctly processed and checked according to defined procedures.
(C) Production and control operations are clearly specified in a written form and GMP requirements are adopted.
(D) The products are designed and developed in a way that takes into account GMP and other codes of practice.
(E) All of the above.
16. The quality control department has other duties which include:
(A) Dealing with complaints about the quality of food from the cafeteria.
(B) Establishing validating and implementing all quality control procedures.
(C) Dealing with complaints about the quality of forecasts from marketing for use by production.
(D) Ensuring that the stability of active ingredients and products is monitored.
17. Assessment of finished products:
(A) Includes the results of in-process testing.
(B) Includes assessment of manufacturing, packaging and quality control documentation.
(C) Includes assessment of compliance of the product with the specifications.
(D) Excludes an examination of the finished pack if everything else checks out satisfactorily.
18. The risks that GMP are designed to reduce are:
(A) In principle mix-ups and cross contamination.
(B) Wrong labelling of the finished pack only and cross contamination.
(C) Expected cross contamination and mix-ups.
(D) Injury or death due to side effects of the drug.
19. Operators need to be trained:
(A) But QC staff may be exempt because they are generally better educated.
(B) In order that they carry out the procedures correctly.
(C) But only when batch rejections occur.
(D) But only when complaints are proven to be their fault.
20. Ensuring that products are fit for their intended use is the responsibility of:
(A) The quality control manager.
(B) The production director.
(C) The chairman.
(D) All senior management and staff at all levels.
Test Paper 2 – GMP Training
Section – Quality Management
11. B (D may be a local requirement if the National Regulator has a mandatory language requirement. If this is the case, all employees must be fluent in the written and spoken language)
16. B and D although D can sometimes be delegated to a research and development or technical department
17. A, B and C
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