BP606T. QUALITY ASSURANCE (Theory)

Unit-I

Introduction to Quality Assurance:

• Definition, scope, and objectives of Quality Assurance.
• Importance of Quality Assurance in the pharmaceutical industry.
• Total Quality Management (TQM):
• Principles and key elements.
• Quality planning, quality control, quality improvement.
• Good Manufacturing Practices (GMP):
• Objectives and guidelines as per WHO and regulatory authorities.
• Documentation in GMP.
• Quality Control:
• Role and responsibilities in pharmaceutical quality control.

Unit-II

Quality Assurance Systems:

• Sources of Quality Variations:
• Variability in raw materials, manufacturing, and control processes.
• In-Process Quality Control (IPQC):
• Objectives and techniques used for monitoring production processes.
• Documentation requirements.
• Finished Product Testing:
• Sampling procedures, batch release testing, and quality assessment.
• Quality Audit:
• Types and procedures for conducting internal and external audits.

Unit-III

Validation in Pharmaceuticals:

• Importance of validation in quality assurance.
• Types of Validation:
• Process validation.
• Cleaning validation.
• Analytical method validation.
• Good Laboratory Practices (GLP):
• Objectives and principles.
• Documentation and compliance requirements.

Unit-IV

Documentation in Quality Assurance:

• Preparation and maintenance of key documents:
• Standard Operating Procedures (SOPs).
• Batch Manufacturing Records (BMRs).
• Batch Packaging Records (BPRs).
• Certificates of Analysis (COAs).
• Change Control and Deviation Handling:
• Importance and procedures for managing changes and deviations.
• Quality Risk Management:
• Identification, evaluation, and mitigation of risks.

Unit-V

Regulatory Aspects of Quality Assurance:

• Role of regulatory bodies:
• USFDA, WHO, MHRA, and other international agencies.
• Quality System Requirements:
• Regulatory expectations and recent advancements.
• Quality by Design (QbD):
• Concept and applications in pharmaceutical development.
• Emerging Trends in Quality Systems:
• Advances in quality assurance techniques and digital solutions for documentation.