Examples of operations and grades for aseptic preparation and processing operations EUGMP- Annex-1

Examples of operations and grades for aseptic preparation and processing operations EUGMP- Annex-1

Question 1. Which activity is performed in Grade A?

A. Cleaning of equipment
B. Aseptic compounding and mixing
C. Preparation of solutions to be filtered
D. Handling of components after cleaning
Answer: B

Question 2. Aseptic assembly of filling equipment belongs to which grade?

A. Grade D
B. Grade C
C. Grade A
D. Grade B
Answer: C

Question 3. Connections made under aseptic conditions post final sterilising grade filter should ideally be sterilized by:

A. Dry heat
B. Steam-in-place
C. Gamma irradiation
D. Peroxide fumigation
Answer: B

Question 4. Replenishment of sterile bulk product occurs in what grade?

A. Grade A
B. Grade B
C. Grade C
D. Grade D
Answer: A

Question 5. Removal and cooling of unprotected items (no packaging) should be performed in:

A. Grade B
B. Grade A
C. Grade C
D. Grade D
Answer: B

Question 6. Grade B serves as:

A. A general warehouse area
B. Background support for Grade A
C. An area for assembling sterile equipment
D. An area for preparing filtered solutions
Answer: B

Question 7. Conveying or staging of equipment protected from the surrounding environment for introduction into Grade A is done in:

A. Grade A
B. Grade B
C. Grade C
D. Grade D
Answer: B

Sterilization EUGMP- Annex-1

Question 8. Preparation of solutions to be filtered is associated with:

A. Grade A
B. Grade B
C. Grade C
D. Grade D
Answer: C

Question 9. Sampling and dispensing during solution preparation occurs in:

A. Grade D
B. Grade C
C. Grade B
D. Grade A
Answer: B

Question 10. Cleaning of equipment belongs to which grade?

A. Grade A
B. Grade B
C. Grade C
D. Grade D
Answer: D

Question 11. Handling of components after cleaning is performed in:

A. Grade D
B. Grade C
C. Grade A
D. Grade B
Answer: A

Question 12. Assembly of cleaned components under HEPA-filtered airflow prior to sterilisation is a Grade:

A. A
B. B
C. C
D. D
Answer: D

Question 13. Assembly of closed and sterilised single-use systems (SUS) using intrinsic sterile connection devices belongs to:

A. Grade A
B. Grade B
C. Grade C
D. Grade D
Answer: D

Question 14. Staging and conveying of sterile primary packaging components in an aseptic filling line (while not wrapped) occurs in:

A. Grade C
B. Grade A
C. Grade B
D. Grade D
Answer: A (inferred as Grade A-related operation)

Question 15. Aseptic filling and sealing of containers such as ampoules are performed in:

A. Grade A
B. Grade B
C. Grade C
D. Grade D
Answer: A

Question 16. Vial closure and transfer of open or partially stoppered containers belong to:

A. Grade D
B. Grade C
C. Grade A
D. Grade B
Answer: C

Question 17. Which grade includes aseptic compounding?

A. Grade C
B. Grade A
C. Grade B
D. Grade D
Answer: B

Question 18. Which grade is directly responsible for supporting aseptic operations in Grade A when not using isolators?

A. Grade C
B. Grade D
C. Grade B
D. Grade A
Answer: C

Question 19. The grade where components are handled after cleaning is:

A. Grade A
B. Grade B
C. Grade C
D. Grade D
Answer: D

Question 20. Solutions to be filtered should be prepared in:

A. Grade A
B. Grade D
C. Grade C
D. Grade B
Answer: C

Question 21. Under which grade are connections made under aseptic conditions (after final sterilising filter) classified?

A. Grade A
B. Grade D
C. Grade C
D. Grade B
Answer: A

Question 22. Which grade involves staging equipment before it enters the Grade A environment?

A. Grade D
B. Grade C
C. Grade B
D. Grade A
Answer: C

Question 23. The background area for aseptic filling activities is typically:

A. Grade A
B. Grade C
C. Grade B
D. Grade D
Answer: C

Question 24. HEPA-filtered assembly of components before sterilization is performed in:

A. Grade D
B. Grade C
C. Grade A
D. Grade B
Answer: A

Question 25. Which grade includes processes that handle sterilized but unpackaged components?

A. Grade A
B. Grade C
C. Grade D
D. Grade B
Answer: A

Question 26. Aseptic filling between the sterilising filter and final container closure is performed in:

A. Grade B
B. Grade A
C. Grade C
D. Grade D
Answer: B

Question 27. Transfers of open or partially stoppered containers occur in which grade?

A. Grade C
B. Grade B
C. Grade A
D. Grade D
Answer: C

Question 28. Which grade specifically deals with operations before filtration?

A. Grade A
B. Grade C
C. Grade B
D. Grade D
Answer: B

Question 29. Which is a Grade A operation?

A. Handling of cleaned equipment
B. Assembly of components under HEPA airflow
C. Aseptic assembly of filling equipment
D. Preparation of solutions
Answer: C

Question 30. Which grade mainly involves support activities for aseptic areas rather than direct aseptic processing?

A. Grade A
B. Grade D
C. Grade B
D. Grade C
Answer: C

Reference – EU Guidelines for GMP- Annex-1