Professional Documents
Culture Documents
Indchemie: Training Questionnaire
Indchemie: Training Questionnaire
TRAINING QUESTIONNAIRE
Title: GMP & cGMP CONSIDARATION Date:
Name: Sign:
There are 60 questions to be answered in 60 minutes. Circle the correct answer(s) clearly. In case of a mistake,
draw a line through the incorrect answer and circle the correct one. Each question carries 1 mark.
2. 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.
TRAINING QUESTIONNAIRE
Title: GMP & cGMP CONSIDARATION Date:
Name: Sign:
14. 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.
15. 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.
2
Indchemie Health Specialities Pvt. Ltd.
Unit–IV, Kumrek, Rangpo, East Sikkim
TRAINING QUESTIONNAIRE
Title: GMP & cGMP CONSIDARATION Date:
Name: Sign:
(D) Excludes an examination of the finished pack if everything else checks out satisfactorily.
18. 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.
20. Recirculation of air within a ventilation system without appropriate efficient filtration:
(A) Is an unacceptable practice and should be stopped by all GMP inspectors.
(B) Is the only economic option and may be used in all facilities.
(C) Will affect the operations that can be carried out in that area.
(D) Depends on the local health and safety rules.
3
Indchemie Health Specialities Pvt. Ltd.
Unit–IV, Kumrek, Rangpo, East Sikkim
TRAINING QUESTIONNAIRE
Title: GMP & cGMP CONSIDARATION Date:
Name: Sign:
TRAINING QUESTIONNAIRE
Title: GMP & cGMP CONSIDARATION Date:
Name: Sign:
5
Indchemie Health Specialities Pvt. Ltd.
Unit–IV, Kumrek, Rangpo, East Sikkim
TRAINING QUESTIONNAIRE
Title: GMP & cGMP CONSIDARATION Date:
Name: Sign:
TRAINING QUESTIONNAIRE
Title: GMP & cGMP CONSIDARATION Date:
Name: Sign:
(D) Should be issued for use only by designated personnel using an approved and documented
procedure.
49. Which of the following is a GMP requirement for documentation:
(Q) To put the pharmacopoeia specifications for raw materials into a company authorized document.
(R) To tell people what to do and when.
(S) To make sure the process operators have something to do while waiting for a manufacturing step
to finish.
(T) To provide an audit trail in the case of a justified customer complaint.
TRAINING QUESTIONNAIRE
Title: GMP & cGMP CONSIDARATION Date:
Name: Sign:
A) Does not need to ensure that stability is tested if there is a development department
B) Does not need a laboratory if the client is willing to do all the testing
C) Is responsible for the investigation of all complaints related to quality of active ingredients
D) Does not approve reprocessing instructions. That is the responsibility of production and
development
59. Self-Inspection audits: -
A) Are a useful way of preventing government inspectors coming to inspect
B) Are useful in ensuring adherence to GMP
C) Does not need to be recorded
D) Is conducted by people from finance and personnel as a means of keeping informed
A) Should be from the step at which processes can have a critical influence on finished product
quality
B) Is only required if there are inspectors from the Government around
C) Is only required if the purchasing company requests it
D) Can only be achieved at much higher cost
TRAINING EVALUATION
Marks obtained
% of marks obtained
Remarks (Pass / Fail)
Retraining (Required / Not Required)
Trainer’s Name
Trainer’s Designation
Trainer’s Signature & Date
8
Indchemie Health Specialities Pvt. Ltd.
Unit–IV, Kumrek, Rangpo, East Sikkim
TRAINING QUESTIONNAIRE
Title: GMP & cGMP CONSIDARATION Date:
Name: Sign:
1. C
2. D
3. A
4. C
5. C
6. C
7. B
8. B
9. C
10. C
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)
12. A
13. D
14. C
15. E
16. B and D although D can sometimes be delegated to a research and development or technical
department
17. A, B and C
18. A
19. B
20. D
9
Indchemie Health Specialities Pvt. Ltd.
Unit–IV, Kumrek, Rangpo, East Sikkim
TRAINING QUESTIONNAIRE
Title: GMP & cGMP CONSIDARATION Date:
Name: Sign:
1. C
2. D
3. A
4. C
5. C
6. C
7. B
8. B
9. C
10. C
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)
12. A
13. D
14. C
15. E
16. B and D although D can sometimes be delegated to a research and development or technical
department
17. A, B and C
18. A
19. B
20. D