PHARMACEUTICAL QUALITY ASSURANCE
Teacher
Mr. HARA GOURI MISHRA
Category
Core Courses
Course Attendees
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Course Reviews
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Course Objectives
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.
Course Outcomes:
| CO | Statement | Mapping with POs |
| CO-1 | Understand the cGMP aspects in a pharmaceutical industry | PO1, PO2, PO8 |
| CO-2 | appreciate the importance of documentation | PO1, PO6, PO9 |
| CO-3 | understand the scope of quality certifications applicable to pharmaceutical industries | PO1, PO2, PO8 |
| CO-4 | understand the responsibilities of QA & QC departments | PO1, PO3, PO6, PO8 |
| CO-5 | To develop skill in Pharmaceutical quality assurance. | PO1, PO2, PO6 |
Course Syllabus
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
Session Plan
Session 1
Definition and concept of Quality control
PPT-SESSION1 QC
Session 2
Quality assurance and GMP
Session 3
Total Quality Management (TQM): Definition, elements, philosophies
PPT-SESSION 3 TQM
Session 4
ICH Guidelines: purpose, participants, process of harmonization
PPT-SESSION 4 ICH
Session 5
Brief overview of QSEM, with special emphasis on Q-series guidelines
PDF-SESSION 5 ICH-Q
Session 6
ICH stability testing guidelines
PPT SESSION 4 ICH S
Session 7
Quality by design (QbD): Definition, overview, elements of QbD program, tools
PDF- SESSION 7 QbD
Session 8
ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for registration
Session 9
NABL accreditation : Principles and procedures
Session 10
Organization and personnel: Personnel responsibilities, training
Session 11
Organization and personnel: Hygiene and personal records.
Session 12
Premises: Design, construction and plant layout,
Session 13
Premises: maintenance, sanitation, environmental control
Session 14
Utilities and maintenance of sterile areas, control of contamination.
Session 15
Equipments and raw materials: Equipment selection, purchase specifications,
Session 16
Equipments and raw materials: maintenance, purchase specifications
Session 17
Maintenance of stores for raw materials
Session 18
Quality Control: Quality control test for containers,
Session 19
Quality control test for rubber closures and secondary packing materials.
Session 20
Good Laboratory Practices: General Provisions, Organization and Personnel,
Session 21
Good Laboratory Practices: Facilities,Equipment,
Session 22
Good Laboratory Practices: Testing Facilities Operation, Test and Control Articles,
Good Laboratory Practices: Testing Facilities Operation, Test and Control Articles,
Session 23
Protocol for Conduct of a Nonclinical Laboratory Study
Session 24
Good Laboratory Practices: Disqualification of Testing Facilities
Session 25
Complaints: Complaints and evaluation of complaints,
Session 26
Complaints: Handling of return good,
Session 27
Recalling and waste disposal.
Session 28
Document maintenance in pharmaceutical industry: Batch Formula Record, Master Formula Record,
Session 29
Document maintenance in pharmaceutical industry: SOP, Quality audit,
Pharmaceutical Quality Assurance reports and documentsDocument maintenance in pharmaceutical industry SOP and Audit
Session 30
Document maintenance in pharmaceutical industry: Quality Review and Quality documentation,
Document maintenance in pharmaceutical industry quality review and quality documentation
Session 31
Document maintenance in pharmaceutical industry: Reports and documents, distribution records.
Session 32
Calibration and Validation: Introduction, definition and general principles of calibration
Introduction, definition, and general principles of calibration
Session 33
Calibration and Validation: qualification and validation
Session 34
Importance and scope of validation
Session 35
Types of validation, validation master plan
Session 36
Calibration of pH meter
Session 37
Qualification of UV-Visible spectrophotometer
Session 39
Principles of Analytical Method Validation
Session 40
Analytical Method Validation, Protocols as per ICH recommended guidelines
Session 41
Calibration of Ph meters and its process
Session 42
Calibration of UV visible spectrophotometer and its Protocol for maintenance
Session 43
Warehousing: Principle, methodology, procedure of management.
Session 45
Calibration and Validation, principle, procedure, difference as per ICH
Our Main Teachers
About Me My self Dr.Bikash Ranjan Jena currently working in Pharmaceutical Analysis & Research Division, School of Pharmacy and Life Sciences (SoPLS), Centurion University, Bhubaneswar since Jan 2021. I have successfully awarded my Ph.D degree at KLEF Deemed to be University, Vaddeswaram, Guntur, A.P on 22nd June 2023. Expertised in Analytical Quality by Design (AQbD), […]