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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.
Upon completion of the course student shall be able to:
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 a Nonclinical 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, validation master plan. Calibration of pH meter, Qualification of UV-Visible spectrophotometer, General principles of Analytical method Validation.
Warehousing: Good warehousing practice, materials management
References:
1. Quality Assurance Guide by organization of Pharmaceutical Products of India.
2. Good Laboratory Practice Regulations, 2nd Edition, Sandy Weinberg Vol. 69.
3. Quality Assurance of Pharmaceuticals- A compendium of Guide lines and Related materials Vol I WHO Publications.
4. A guide to Total Quality Management- Kushik Maitra and Sedhan K Ghosh
5. How to Practice GMP’s – P P Sharma. 6. ISO 9000 and Total Quality Management – Sadhank G Ghosh
7. The International Pharmacopoeia – Vol I, II, III, IV- General Methods of Analysis and Quality specification for Pharmaceutical Substances, Excipients and Dosage forms
8. Good laboratory Practices – Marcel Deckker Series
9. ICH guidelines, ISO 9000 and 14000 guidelines
Definition and concept of Quality control
PPT-SESSION1 QC
Quality assurance and GMP
Total Quality Management (TQM): Definition, elements, philosophies
PPT-SESSION 3 TQM
ICH Guidelines: purpose, participants, process of harmonization
PPT-SESSION 4 ICH
Brief overview of QSEM, with special emphasis on Q-series guidelines
PDF-SESSION 5 ICH-Q
ICH stability testing guidelines
PPT SESSION 4 ICH S
Quality by design (QbD): Definition, overview, elements of QbD program, tools
PDF- SESSION 7 QbD
ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for registration
NABL accreditation : Principles and procedures
Organization and personnel: Personnel responsibilities, training
Organization and personnel: Hygiene and personal records.
Premises: Design, construction and plant layout,
Premises: maintenance, sanitation, environmental control
Utilities and maintenance of sterile areas, control of contamination.
Equipments and raw materials: Equipment selection, purchase specifications,
Equipments and raw materials: maintenance, purchase specifications
Maintenance of stores for raw materials
Quality Control: Quality control test for containers,
Quality control test for rubber closures and secondary packing materials.
Good Laboratory Practices: General Provisions, Organization and Personnel,
Good Laboratory Practices: Facilities,Equipment,
Good Laboratory Practices: Testing Facilities Operation, Test and Control Articles,
Protocol for Conduct of a Nonclinical Laboratory Study
Good Laboratory Practices: Disqualification of Testing Facilities
Complaints: Handling of return good,
Recalling and waste disposal.
Document maintenance in pharmaceutical industry: Batch Formula Record, Master Formula Record,
Document maintenance in pharmaceutical industry: SOP, Quality audit,
Document maintenance in pharmaceutical industry: Quality Review and Quality documentation,
Document maintenance in pharmaceutical industry: Reports and documents, distribution records.
Calibration and Validation: Introduction, definition and general principles of calibration
Calibration and Validation: qualification and validation,
Importance and scope of validation
Types of validation, validation master plan.
Calibration of pH meter
Qualification of UV-Visible spectrophotometer
General principles of Analytical method Validation
Warehousing: Good warehousing practice
Warehousing: materials management