Quality Assurance Book for B.Pharm 6th Semester
| Author’s Name | Prof. Dr. R. Sundhararajan Dr.M.V.Kumudhavalli Dr. (Mrs). Minal T. Harde |
| Editions | Latest Edition |
| Publishers | Thakur Publication Pvt Ltd |
SEMESTER-VI PHARMACEUTICAL QUALITY ASSURANCE Paperback
| Author’s Name | Dr. Sohan Chitlange, Dr. Rupali Kale |
| Editions | First Edition |
| Publishers | Nirali Prakashan |
TPS Pharmaceutical Quality Assurance Paperback
| Author’s Name | Dr. Amit N. Maliye, Dr. Rajesh A. Sahu, Mrs. Rashmi R. Mishra |
| Editions | Latest Edition |
| Publishers | ABD Publishers and Printers Pvt. Ltd. |
NEW CONCEPTS IN PHARMA QUALITY ASSURANCE (SEM VI)
| Author’s Name | AND SUSHMA DR. ANUP, SNEHAL |
| Editions | Latest Edition |
| Publishers | S VIKAS AND COMPANY (PV) |
Pharmaceutical Quality Assurance Topic-wise Summary
Unit 1
1. Quality Assurance and Quality Management Concepts
- Introduction
- Definitions
- Concepts of quality control, quality assurance, and GMP
2. Total Quality Management (TQM)
- Introduction
- Definitions
- Elements
- Philosophies
3. Guidelines of ICH
- Introduction
- Definitions
- Purpose
- Short overview of QSEM
- Process of harmonization with special emphasis on Q-series guidelines
- ICH stability testing guidelines and criteria
4. Quality by Design (QbD)
- Introduction
- Definitions
- Overview
- Tools
- Elements of QbD program
5. ISO 9000 and ISO 14000
- Introduction
- Definitions
- Overview
- Advantages
- Elements
- Steps for registration
6. NABL Accreditation
- Principles
- Definitions
- Procedures of NABL accreditation
Unit 2
1. Organization and Personnel
- Organization and personnel responsibilities
- Training
- Hygiene
- Personal records
2. Premises
- Design and construction of plant layout
- Maintenance
- Environmental control
- Sanitation
- Utilities and maintenance of sterile areas
- Control of contamination
3. Equipment and Raw Materials
- Equipment selection and maintenance
- Purchase specifications
- Storage for raw materials
Unit 3
1. Quality Control
- Test for containers
- Secondary packaging materials
- Rubber closures
2. Good Laboratory Practices (GLP)
- Facilities
- General provisions
- Organization and personnel
- Equipment
- Testing facilities operations
- Protocol for the conduct of a nonclinical laboratory study
- Test and control articles
- Records and reports
- Disqualification of testing facilities
Unit 4
1. Different Complaints
- Evaluation of complaints
- Handling of returned goods
- Recall procedures
- Waste disposal materials
2. Document Maintenance in the Pharmaceutical Industry
- Batch formula records
- Master formula records
- Quality audit
- Standard Operating Procedures (SOPs)
- Reports and documents
- Quality review and quality documentation
- Distribution records
Unit 5
1. Calibration and Validation Process
- Definitions
- General principles of calibration
- Importance and scope of validation
- Qualifications and validation
- Types of validation
- Validation master plans
- Qualification of UV–Visible spectrophotometer
- General principles of analytical method validation
2. Warehousing
- Materials management
- Good warehousing practices