Exam Details
| Subject | audits and regulatory compliance | |
| 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 II) (New CBCS) Examination, 2018
Pharmaceutical Quality Assurance
Audits and Regulatory Compliance
Day and Date Friday, 11-5-2018 Max. Marks 75
Time 10.30 a.m. to 1.30 p.m.
I. Answer any five questions
Describe the role of regulatory audits in pharmaceutical industry.
Enlist the guidelines for good documentation practices in audits.
Explain the method of loan license auditing.
What are the administrative responsibilities with respect to quality audits
Explain basic principles of internal audits.
Explain the process of auditing packaging department.
II. Answer any three questions (3×10=30)
Enlist and describe the parameters used by the manufacturer in the form of checklist for employee training and audit.
Explain the process of auditing a microbiology lab.
What are the protocols to be followed in selecting vendors Add a note on purchase, storage and release of raw materials.
What are the objectives of performing a third party audit Describe the usefulness of performing such audits.
III. What are the different types of audits Explain in detail audit methods and techniques involved in it. 20
Pharmaceutical Quality Assurance
Audits and Regulatory Compliance
Day and Date Friday, 11-5-2018 Max. Marks 75
Time 10.30 a.m. to 1.30 p.m.
I. Answer any five questions
Describe the role of regulatory audits in pharmaceutical industry.
Enlist the guidelines for good documentation practices in audits.
Explain the method of loan license auditing.
What are the administrative responsibilities with respect to quality audits
Explain basic principles of internal audits.
Explain the process of auditing packaging department.
II. Answer any three questions (3×10=30)
Enlist and describe the parameters used by the manufacturer in the form of checklist for employee training and audit.
Explain the process of auditing a microbiology lab.
What are the protocols to be followed in selecting vendors Add a note on purchase, storage and release of raw materials.
What are the objectives of performing a third party audit Describe the usefulness of performing such audits.
III. What are the different types of audits Explain in detail audit methods and techniques involved in it. 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)