QUALITY ASSURANCE
B.PHARMA SEMESTER VII
Scope: This course deals with the various aspects of quality control and quality assurance aspects of pharmaceutical industries. It deals with the important aspects like cGMP, QC tests, documentation, quality certifications and regulatory affairs.
Objectives: Upon completion of the course the student shall be able to
- understand the cGMP aspects in a pharmaceutical industry
- appreciate the importance of documentation
- understand the scope of quality certifications applicable to pharmaceutical industries
- understand the responsibilities of QA & QC departments.
Quality Assurance and Quality Management concepts (Click Here)
Total Quality Management (TQM) (Click Here)
ICH Guidelines (Click Here)
Quality by design (QbD (part 1)(part 2)
ISO 9000 & ISO14000 (Click Here)
NABL accreditation (Click Here)
Organization and personnel (Click Here)
Premises (Click Here)
Equipments and raw materials (Click Here)
Quality Control (Click Here)
Good Laboratory Practices (Click Here)
Complaints (Click Here)
Document maintenance in pharmaceutical industry (Click Here)
Calibration and Validation (Click Here)
Warehousing (Click Here)
