Exam Details

Subject quality assurance
Paper
Exam / Course m.pharm. pharmaceutics
Department
Organization solapur university
Position
Exam Date May, 2018
City, State maharashtra, solapur


Question Paper

M. Pharm. (Semester (CBCS/CGPA) Examination, 2018
Pharmaceutical Quality Assurance (Elective
Quality Assurance
Day and Date Tuesday, 8-5-2018 Total Marks 70
Time 10.30 a.m. to 1.30 p.m.
Instruction All questions are compulsory.
A. Answer any three (10×3=30)
Write notes on the following
Complaint handling.
ii) Applications of computers in GMPs .
Giving relevant examples, give the details regarding the components and management of Batch Manufacturing Records.
Describe the GMP aspects of Laboratory controls in Pharma manufacturing.
Give an account of handling of returned and salvaged products.
B. Answer the following (20×2=40)
What are the requirements of management systems to meet the demand of Corrective and Preventive Actions Discuss in detail.
Explain the ways to avoid making the common GMP errors. Describe the role of documentation for compliance to the GMP requirements.


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)