Uttar Pradesh Technical University (UPTU) 2010 B.Pharm GMP Quality Assurance and Validation - Question Paper

B. Pharm (UPTU)
Eighth Semester Examination, 2009-10
GMP Quality Assurance and Validation

Time: three Hours Total Marks: 80

Note: 1) Attempt All ques..
2) All ques. carry equal marks.

1) Attempt any Two: (2×8=16)
a) i) elaborate the WHO requirements for biological substance?
ii) Write a brief note on Good Laboratory Practices.
b) Discuss the salient features of CFR 21.
c) i) What is the process for registration and certification for ISO 9000 series?
ii) What is the GMP requirement for personnel and building facilities?

2) Attempt any Four: (4×4=16)
a) What do you understand by master formula record? Write a brief note.
b) What is the importance of documentation in pharmaceutical industry?
c) What are Standard Operating Procedures (SOPs)?
d) Write a detailed note on NDA.
e) What are the requirements for investigational new drug approval?

3) Attempt any Four: (4×4=16)
a) Write a brief note on Total Quality Management.
b) What are the quality control tests for glass containers for parental product?
c) "Quality assurance and quality control are the 2 faces of the identical coin". Comment.
d) Discuss the terms quality, quality control and quality assurance.
e) What are the sources of quality variation in pharmaceutical process?

4) Attempt any Four: (4×4=16)
a) Discuss the concept of validation in pharmaceutical processes.
b) Distinguish ranging from Prospective and Retrospective process validation.
c) How will you control process variables?
d) Explain protocol for analytical methods validation.
e) Discuss guidelines for process validation of solid dosage forms.

5) Attempt any Two: (2×8=l6)
a) What is the objective of IPQC system? Write a detailed note on in-process quality control tests for parental products.
b) i) What is Normal Frequency Distribution trend for product quality?
ii) What are the salient features of packaging control?
c) What is the importance of sampling? explain salient features of a good statistical sampling plan and procedure in detail.

Earning:   Approval pending.