Introduction To Good Manufacturing Practice (GMP)

The quality of pharmaceutical products is subject to a lot of scrutiny and meticulousness regarding quality because anything less than the best possible quality will result in financial losses and regulatory issues for companies. Good Manufacturing Practice (GMP) is a set of guidelines used to ensure consistency in the manufacture of quality healthcare products. These guidelines cut across the different facets and departments involved in the manufacturing process including sourcing for and purchasing raw materials, training personnel, validating and monitoring systems, and documentation. This course provides a detailed introduction to the concept, helping participants. understand why some regulations are in place. You will also learn about the roles of the WHO and other regulatory agencies in enforcing GMP.

In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

Curriculum

Introduction: Good Manufacturing Practice (GMP): Definitions and Scope

• Definition
• Why is GMP important?
• What is GMP?

Lesson 1: Importance Of Organization and Personnel in GMP

• Introduction
• Personnel: Qualifications and Experience
• Personnel Training
• Personal Hygiene and Health
• Personal Responsibility
• Consultants

Lesson 2: Buildings, Surroundings, and Facilities

• Ancillary Areas
• Storage Areas
• Weighing Areas
• Production Areas
• Quality Control Areas

Lesson 3: Equipment

• Introduction
• Design, Size, Location, and Construction of Equipment
• Design
• Size
• Location
• Construction
• Equipment Identification
• Equipment Log
• Cleaning and Maintenance of Equipment

Lesson 4: Materials Management System

• Introduction
• Purchasing
• Raw Materials
• Package Materials

Lesson 5: Quality Management System

• Objectives of Quality Management
• Quality Management System
• Quality
• Quality by Design and Product Development
• Risk Management and Risk Assessment
• Corrective and Preventive Action (CAPA)
• The Quality Unit

Lesson 6: Manufacturing Operations and Control

• Identity
• Strength
• Safety

Lesson 7: Documentation and Records

• Steps in Total PMD Program
• Guidelines for Designing and Implementing PMD Program
• Definition of Documentation
• Objectives of Documentation
• Importance of Documentation
• Preparation, Issue, and Use of Documents
• Product Traceability
• Storage and Retention of Documents and Records
• Storage and Retrieval of Documents
• Disposal of Document

Lesson 8: Pharmaceutical Validation

• Introduction
• Scope of Validation
• Analytical Test Method
• Instrument Calibration
• Process Utility Services
• Raw Materials and Packaging Materials
• Equipment
• Facilities
• Product Design
• Cleaning
• Operators
• Importance of Validation
• Reduction of Quality Costs
• Preventive Costs
• Appraisal Costs
• Internal Failure Costs
• External Failure Costs
• Process Optimization
• Assurance of Quality
• Safety
• Limitations of Validation

Lesson 9: Outsourcing

• Introduction
• Manufacturing and Packaging Outsourcing
• Contract Giver
• Contract Acceptor
• The Contract
• Analytical Outsourcing
• Other Services Outsourcing

Lesson 10: Post Operational Activities

• Introduction
• Distribution
• Recalled Products
• Returned Products
• Complaints and Adverse Events
• Adverse Events
• Drug Product Salvaging

Lesson 11: Site and Plant Security

• Introduction
• Security Personnel
• Security Manager
• Security Staff
• Entry to Site
• Entry to Plant Buildings
• Internal Security
• Current Issues

Lesson 12: Pharmaceutical Audits

• Introduction
• Internal Audits
• External Audits
• Regulatory Audits
• Designing of Internal Audit System
• Implementing Internal Audit System
• How Should the Department Prepare for the Audit?

Lesson 13: Safety and Environmental Protection

• Introduction
• Safety
• Environmental Protection and Procedures

Conclusion

Glossary

Quiz