Exam Details
| Subject | quality controls and quality assurance | |
| Paper | ||
| Exam / Course | m. pharmacy (pharm. analysis) | |
| Department | ||
| Organization | G. Pulla Reddy College Of Pharmacy | |
| Position | ||
| Exam Date | February, 2019 | |
| City, State | telangana, hyderabad |
Question Paper
FACULTY OF PHARMACY
M. Pharmacy (Pharmaceutical Analysis) II-Semester (Suppl.) Examination,
February 2019
Subject: Quality Controls and Quality Assurance
Time: 3 Hours Max. Marks: 75
Note: Answer any five questions. All questions carry equal marks.
1 Write a short note on the following
Quality control.
Quality assurance.
Non clinical testing.
2 Explain the various CPSCEA guidelines for laboratory animal facility.
3 Define IPQC. Explain in detail about various IPQC tests for
Capsules.
Parenterals.
4 Give a brief note on
Quality audit plan.
Protocols and reports.
Distribution records.
5 Discuss the Good laboratory practices for a quality control laboratory in detail.
6 Explain the various documents to be maintained by the quality control
department.
Explain Master formula and Batch formula records.
7 Explain various cGMP guidelines according to schedule M.
8 Write a note on
Sanitation of manufacturing premises
Drug product inspection.
Production record review.
M. Pharmacy (Pharmaceutical Analysis) II-Semester (Suppl.) Examination,
February 2019
Subject: Quality Controls and Quality Assurance
Time: 3 Hours Max. Marks: 75
Note: Answer any five questions. All questions carry equal marks.
1 Write a short note on the following
Quality control.
Quality assurance.
Non clinical testing.
2 Explain the various CPSCEA guidelines for laboratory animal facility.
3 Define IPQC. Explain in detail about various IPQC tests for
Capsules.
Parenterals.
4 Give a brief note on
Quality audit plan.
Protocols and reports.
Distribution records.
5 Discuss the Good laboratory practices for a quality control laboratory in detail.
6 Explain the various documents to be maintained by the quality control
department.
Explain Master formula and Batch formula records.
7 Explain various cGMP guidelines according to schedule M.
8 Write a note on
Sanitation of manufacturing premises
Drug product inspection.
Production record review.
Other Question Papers
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