Pharmaceutical Quality Assurance Syllabus PDF | B.Pharm 6th Semester | Old Syllabus

Pharmaceutical Quality Assurance is a B.Pharm 6th Semester subject dealing with quality control and quality assurance aspects of pharmaceutical industries, including cGMP, quality control tests, documentation, quality certifications and regulatory affairs.

About This Syllabus

This course deals with the various aspects of quality control and quality assurance in pharmaceutical industries. It covers cGMP, quality control tests, documentation, quality certifications and regulatory affairs.

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 and philosophies
• ICH Guidelines: purpose, participants and process of harmonization
• Brief overview of Q-series guidelines
• ICH stability testing guidelines
• Quality by Design (QbD): definition, overview, elements of QbD programme and tools
• ISO 9000 and ISO 14000: overview, benefits, elements and steps for registration
• NABL accreditation: principles and procedures

Unit II – Organization, Premises, Equipment and Raw Materials

• Personnel responsibilities
• Training, hygiene and personal records
• Premises: design, construction and plant layout
• Maintenance and sanitation
• Environmental control
• Utilities and maintenance of sterile areas
• Control of contamination
• Equipment selection
• Purchase specifications and maintenance
• Stores for raw materials

Unit III – Quality Control and Good Laboratory Practices

• Quality control tests 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, Documentation and Validation

• Complaints and evaluation of complaints
• Handling of returned goods
• Recalling and waste disposal
• Document maintenance in pharmaceutical industry
• Batch Formula Record
• Master Formula Record
• Standard Operating Procedures (SOPs)
• Quality audit
• Quality review and quality documentation
• Reports and records

Unit V – Calibration and Validation

• Calibration: introduction, definition and general principles
• Validation: introduction, definition, importance and scope
• Types of validation
• Calibration of pH meter
• Qualification of UV-Visible spectrophotometer
• General principles of analytical method validation

About This Syllabus

This page provides the Pharmaceutical Quality Assurance syllabus for B.Pharm 6th Semester. The course focuses on quality assurance, quality control, GMP, documentation, laboratory practices, calibration and validation in pharmaceutical industries.

The original syllabus PDF is available below for students who want to download and refer to the complete document.