BP606T. PHARMACEUTICAL QUALITY ASSURANCE Books
“Pharmaceutical Quality Assurance: Ensuring drug safety and efficacy through quality control, regulatory compliance, and risk management.”
Course Content
Unit Title
Content
UNIT-I
- Quality Assurance and Quality Management concepts: Definition and concept of Quality control, Quality assurance and GMP
- Total Quality Management (TQM): Definition, elements, philosophies
ICH Guidelines: purpose, participants, process of harmonization, Brief overview of QSEM, with special emphasis on Q-series guidelines, ICH stability testing guidelines - Quality by design (QbD): Definition, overview, elements of QbD program, tools
- ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for registration
NABL accreditation : Principles and procedures
UNIT-II
- Organization and personnel: Personnel responsibilities, training, hygiene and personal records.
- Premises: Design, construction and plant layout, maintenance, sanitation, environmental control, utilities and maintenance of sterile areas, control of contamination.
- Equipments and raw materials: Equipment selection, purchase specifications, maintenance, purchase specifications and maintenance of stores for raw materials.
UNIT-III
- Quality Control: Quality control test for containers, rubber closures and secondary packing materials.
- Good Laboratory Practices: General Provisions, Organization and Personnel, Facilities, Equipment, Testing Facilities Operation, Test and Control Articles, Protocol for Conduct of aNonclinical Laboratory Study, Records and Reports, Disqualification of Testing Facilities
UNIT-IV
- Complaints: Complaints and evaluation of complaints, Handling of return good, recalling and waste disposal.
- Document maintenance in pharmaceutical industry: Batch Formula Record, Master Formula Record, SOP, Quality audit, Quality Review and Quality documentation, Reports and documents, distribution records.
UNIT-V
- Calibration and Validation: Introduction, definition and general principles of calibration, qualification and validation, importance and scope of validation, types of validation, validationmaster plan. Calibration of pH meter, Qualification of UV-Visible spectrophotometer, General principles of Analytical method Validation.
- Warehousing: Good warehousing practice, materials management
Learning Objectives
- Understand the cGMP aspects in a pharmaceutical industry
- Understand the scope of quality certifications applicable to pharmaceutical industries
- Understand the responsibilities of QA & QC departments.
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