MQA202T - Pharmaceutical Validation (M. Pharmacy: Quality Assurance Specialization)

Scope: 

• The main purpose of the subject is to understand about validation and how it can be applied to industry and thus improve the quality of the products. 
• The subject covers the complete information about validation, types, methodology and application.

Objectives: At the completion of this course, it is expected that students will be able to understand 

• The concepts of calibration, qualification, and validation 
• The qualification of various equipment's and instruments
• Process validation of different dosage forms
• Validation of an analytical method for estimation of drugs
• Cleaning validation of equipments employed in the manufacture of pharmaceuticals 

Topics as per PCI M Pharmacy syllabus:

1.  Introduction to validation
2. Qualification of manufacturing equipments
3. Qualification of laboratory equipments
4. Process validation
5. Cleaning validation
6. General Principles of Intellectual Property 

Course Outcomes: