Exam Details
| Subject | audits and regulatory compliance | |
| Paper | ||
| Exam / Course | m.pharm. pharmaceutics | |
| Department | ||
| Organization | solapur university | |
| Position | ||
| Exam Date | December, 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 Thursday, 13-12-2018 Max. Marks 75
Time 10.30 a.m. to 1.30 p.m.
I. Answer any five questions
Discuss the scope of performing an internal audit.
Write a note on pre-audit information gathering.
Describe the role of auditing function in Total Quality Management.
Explain the significance of documentation in regulatory audits.
What are the management responsibilities with respect to quality audits
Explain the process of auditing a warehouse.
II. Answer any three questions (3×10=30)
Write a note on
Quality audit
Loan license auditing.
Describe the process of handling the audit deficiencies.
Describe the content of GMP audit checklist for the manufacturer.
Explain briefly the criteria for the selection of vendors with respect to raw
materials.
III. What is Quality Audit What is the scope of Quality Audit Explain in detail
the important types of Quality Audits. 20
(Pharmaceutical Quality Assurance)
Audits and regulatory compliance
Day and Date Thursday, 13-12-2018 Max. Marks 75
Time 10.30 a.m. to 1.30 p.m.
I. Answer any five questions
Discuss the scope of performing an internal audit.
Write a note on pre-audit information gathering.
Describe the role of auditing function in Total Quality Management.
Explain the significance of documentation in regulatory audits.
What are the management responsibilities with respect to quality audits
Explain the process of auditing a warehouse.
II. Answer any three questions (3×10=30)
Write a note on
Quality audit
Loan license auditing.
Describe the process of handling the audit deficiencies.
Describe the content of GMP audit checklist for the manufacturer.
Explain briefly the criteria for the selection of vendors with respect to raw
materials.
III. What is Quality Audit What is the scope of Quality Audit Explain in detail
the important types of Quality Audits. 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)