PHARMACEUTICAL QUALITY ASSURANCE

 UNIT – I 

Quality Assurance and Quality Management concepts: (NIRALI PUB.)

• Definition and concept of Quality control
• Quality assurance and GMP 

Total Quality Management (TQM): (NIRALI PUB.)

Definition, elements, philosophies 

ICH Guidelines: (NIRALI PUB.)

• Purpose, participants, process of harmonization
• Brief overview of QSEM, with special emphasis on Q-series guidelines
• ICH stability testing guidelines 

Quality by design (QbD): (NIRALI PUB.)

• Definition 
• Overview
• Elements of QbD program, 
• Tools 

ISO 9000 & ISO14000: (NIRALI PUB.)

• Overview
• Benefits
• Elements 
• Steps for registration 

NABL accreditation : (NIRALI PUB.)

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: (NIRALI PUB.)

• Equipment selection 
• Purchase specifications 
• Maintenance 
• Purchase specifications 
• Maintenance of stores for raw materials. 

UNIT – III 

Quality Control: (NIRALI PUB.)

Quality control test for containers, rubber closures and secondary packing materials. 

Good Laboratory Practices: (NIRALI PUB.)

• 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: ( Another PPT ) (NIRALI PUB.)

• Complaints and evaluation of complaints
• Handling of return good
• Recalling and waste disposal

Document maintenance in pharmaceutical industry: (Another note) (NIRALI PUB.)

• 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
• Generalprinciples of Analytical method Validation

Warehousing: (NIRALI PUB.)

• Good warehousing practice
• Materials management 

Recommended Books: (Latest Edition) 

1. Quality Assurance Guide by organization of Pharmaceutical Products of India. 

2. Good Laboratory Practice Regulations, 2 nd 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