UNIMARK REMEDIES LIMITED BAVLA ASSESSMENT ON GMP TRAINING NAME OF THE PERSON : DEPARTMENT controls MINIMUM QUALIFYING MARK

: 6 Date ::

DESIGNATION :

MODULE: Laboratory

1. " What is the significance of stability studies on Active ingredients? a) Assigning of retesting period products c) Recommendations for storage conditions 2. Stability studies on API should be conducted in a) Plastic containers c) Similar to Market pack 3. Impurity profile should describe the following a) identified impurities c) Both a & b a) 1 batch c) 2 batches a) At least twice required for all tests 6. Any OOS should be -----------------------and documented a)Investigated a) Labeling a) Regulatory submissions c) Both a & b 9. b) recorded b) Use before b) Historical data d) None of the above 7. Analytical reagents or standard solutions should have a -------------------- date. 8. Impurity profile should be compared at appropriate intervals against the following b) unidentified impurities d) None of the above b) 3 batches d) No batch b) Three times required for all tests b) Glass containers d) No recommendations b) Potential toxicity on decomposition

d) a & c

4. What is the number of batches to be charged for stability of API annually

5. What is the quantity of reserve samples of API that is required to be retained

For an active ingredient the reserve sample shall be retained for _____ year after expiry .

10. Where appropriate the stability storage conditions should be consistent with a) ICH guidelines MARKS SCORED SIGNATURE OF THE EVALUATER b) SUPAC guidelines : :