Exam Details
| Subject | product development and technology transfer | |
| Paper | ||
| Exam / Course | m.pharm. pharmaceutics | |
| Department | ||
| Organization | solapur university | |
| Position | ||
| Exam Date | May, 2018 | |
| City, State | maharashtra, solapur |
Question Paper
M.Pharmacy (Semester (New CBCS) Examination, 2018
pharmaceutical Quality Assurance
Product Development and Technology Transfer
Day and Date Saturday, 12-5-2018 Total Marks 75
Time 10.30 a.m. to 1.30 p.m.
1. Answer any five questions
Discuss the technology transfer documentation.
Write note on Aseptic packaging systems.
Distinguish between thermoplastic and thermosetting materials.
Explain the Investigational New Drugs Application (IND).
Describe different packaging materials used for primary packing.
Discuss the importance of particle size, shape and surface area in formulation design.
2. Answer any three questions. (3×10=30)
Discuss in detail about the problems during the technology transfer from R and D to plant scale of novel drug delivery systems.
Discuss in detail about different types of Pharmaceutical containers and closures including their merits and demerits.
Describe various approaches of "pilot plant scale up techniques". Explain its significance with reference to pharmaceutical industries.
Explain the role of various Physico-Chemical characteristics of a new drug molecule in preformulation studies.
3. Discuss the evaluation of glass containers used in packaging of pharmaceutical
preparation. 20
pharmaceutical Quality Assurance
Product Development and Technology Transfer
Day and Date Saturday, 12-5-2018 Total Marks 75
Time 10.30 a.m. to 1.30 p.m.
1. Answer any five questions
Discuss the technology transfer documentation.
Write note on Aseptic packaging systems.
Distinguish between thermoplastic and thermosetting materials.
Explain the Investigational New Drugs Application (IND).
Describe different packaging materials used for primary packing.
Discuss the importance of particle size, shape and surface area in formulation design.
2. Answer any three questions. (3×10=30)
Discuss in detail about the problems during the technology transfer from R and D to plant scale of novel drug delivery systems.
Discuss in detail about different types of Pharmaceutical containers and closures including their merits and demerits.
Describe various approaches of "pilot plant scale up techniques". Explain its significance with reference to pharmaceutical industries.
Explain the role of various Physico-Chemical characteristics of a new drug molecule in preformulation studies.
3. Discuss the evaluation of glass containers used in packaging of pharmaceutical
preparation. 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)