Exam Details
| Subject | quality control and quality assurance | |
| Paper | ||
| Exam / Course | m.pharm. pharmaceutics | |
| Department | ||
| Organization | solapur university | |
| Position | ||
| Exam Date | May, 2018 | |
| City, State | maharashtra, solapur |
Question Paper
Master of Pharmacy (Semester (New CBCS) Examination, 2018
Pharmaceutical Quality Assurance
Quality Control and Quality Assurance
Day and Date Tuesday, 8-5-2018 Max. Marks 75
Time 10.30 a.m. to 1.30 p.m.
I. Answer any five questions.
What are quality, quality control and quality assurance
Give the IPQC and FPQC tests for capsules.
What are distribution records
What is aseptic process control
What are CDER and CBER
Give overview of ICH guidelines.
II. Answer any three questions. (3×10=30)
Define control article and test article. How is non clinical laboratory study result prepared and stored
Discuss the analysis of raw materials, finished product.
What is the format of SOP Explain with example.
Write note on production and process control.
III. What are cGMPs Why are cGMPs so important Explain the GMP guidelines
for design, construction and sanitation of building.
20
Pharmaceutical Quality Assurance
Quality Control and Quality Assurance
Day and Date Tuesday, 8-5-2018 Max. Marks 75
Time 10.30 a.m. to 1.30 p.m.
I. Answer any five questions.
What are quality, quality control and quality assurance
Give the IPQC and FPQC tests for capsules.
What are distribution records
What is aseptic process control
What are CDER and CBER
Give overview of ICH guidelines.
II. Answer any three questions. (3×10=30)
Define control article and test article. How is non clinical laboratory study result prepared and stored
Discuss the analysis of raw materials, finished product.
What is the format of SOP Explain with example.
Write note on production and process control.
III. What are cGMPs Why are cGMPs so important Explain the GMP guidelines
for design, construction and sanitation of building.
20
Other Question Papers
Subjects
- advanced biopharmaceutics and pharmacokinetics
- advanced pharmaceutical analysis (old)
- advanced pharmaceutical chemistry – i (old)
- advanced pharmaceutical chemistry – ii
- advanced pharmaceutical chemistry – iii (old) (cgpa/cbcs)
- advanced pharmaceutics – ii
- advanced pharmaceutics – iii (old)
- advances in drug delivery (old)
- audits and regulatory compliance
- computer aided drug delivery system
- cosmeticology (elective)
- cosmetics and cosmeceutica
- cosmetics and cosmeceuticals
- drug delivery system
- drug design (elective) (old)
- elective : quality control (old)
- hazards and safety management
- modern pharmaceutical analytical technique
- modern pharmaceutical analytical techniques
- modern pharmaceutics
- molecular pharmaceutics (nano tech and targeted dds)
- pharmaceutical manufacturing technology
- pharmaceutical validation
- pharmaceutics (biopharmaceutics and pharmacokinetics(old) (elective)
- product development (elective)(old)
- product development and technology transfer
- quality assurance
- quality assurance techniques – i
- quality assurance techniques – ii (old)
- quality assurance techniques – iii
- quality control (old)
- quality control and quality assurance
- quality management system
- regulatory affairs
- sterile product formulation and technology
- sterile product formulation and technology (old) (elective)
- therapeutic drug monitoring (old) (elective)