About Course
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 student shall be able to:
1. Understand the cGMP aspects in the pharmaceutical industry
2. Appreciate the importance of documentation
3. Understand the scope of quality certifications applicable to pharmaceutical industries
4. Understand the responsibilities of QA & QC departments
Course Content
UNIT 1: Quality Assurance and Quality Management concepts, Total Quality Management, ICH Guidelines, Quality by design, ISO 9000 & ISO14000, NABL accreditation
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CLASS 1: Quality Management concepts: Definition and concept of Quality control,
00:00 -
CLASS 2: Quality assurance and GMP
00:00 -
CLASS 3: Total Quality Management (TQM)
00:00 -
CLASS 4: ICH Guidelines
00:00 -
CLASS 5: Brief overview of QSEM
00:00 -
UNIT 6: ICH stabilitytesting guidelines
00:00 -
CLASS 7: Quality by design (QbD)
00:00 -
CLASS 8: Quality by design (QbD) TOOLS
00:00 -
UNIT 9:
00:00 -
UNIT 10 : NABL accreditation
00:00
UNIT 2: Organization and personnel, Premises, Equipments and raw materials
UNIT 3: Quality Control, Good Laboratory Practices
UNIT 4: Complaints, Document maintenance in pharmaceutical industry
UNIT 5: Calibration and Validation, Warehousing
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