Exam Details
| Subject | quality control and quality assurance | |
| Paper | ||
| Exam / Course | m.pharm. pharmaceutics | |
| Department | ||
| Organization | solapur university | |
| Position | ||
| Exam Date | December, 2018 | |
| City, State | maharashtra, solapur |
Question Paper
Master of Pharmacy (Sem. (CBCS) Examination, 2018
PHARMACEUTICAL QUALITY ASSURANCE
Quality Control and Quality Assurance
Day and Date Wednesday, 12-12-2018 Max. Marks 75
Time 10.30 a.m. to 1.30 p.m.
I. Answer any five questions
Give the scope of GLP.
Which are the drug manufactures covered under usfda GMP guidelines
Brief the analysis of raw materials.
What are the SOPs of SOP
What are CDER and CBER
Give overview of ICH guidelines.
II. Answer any three questions (3×10=30)
Give QC tests for containers, closures and secondary packaging
materials.
Give details of the batch formula record.
Describe the IPQC and FPQC tests for tablets and capsules.
Describe the sampling and testing of in-process materials and drug
product.
III. What is EMA Explain the GMP guidelines for design, construction, sanitation
and maintenance of building. 20
PHARMACEUTICAL QUALITY ASSURANCE
Quality Control and Quality Assurance
Day and Date Wednesday, 12-12-2018 Max. Marks 75
Time 10.30 a.m. to 1.30 p.m.
I. Answer any five questions
Give the scope of GLP.
Which are the drug manufactures covered under usfda GMP guidelines
Brief the analysis of raw materials.
What are the SOPs of SOP
What are CDER and CBER
Give overview of ICH guidelines.
II. Answer any three questions (3×10=30)
Give QC tests for containers, closures and secondary packaging
materials.
Give details of the batch formula record.
Describe the IPQC and FPQC tests for tablets and capsules.
Describe the sampling and testing of in-process materials and drug
product.
III. What is EMA Explain the GMP guidelines for design, construction, sanitation
and maintenance 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)