The Good Manufacturing Practice (GMP) Training Course provides participants with an in-depth understanding of the regulatory, operational, and quality management requirements needed to ensure the manufacture of safe, high-quality, and compliant products. This course covers the core GMP principles applicable to pharmaceuticals, food and beverage, medical devices, cosmetics, and other regulated industries.

Participants will gain practical insights into quality systems, documentation requirements, process controls, facility and equipment standards, personnel qualifications, and industry best practices. Through real-world case studies, interactive exercises, and practical examples, learners will strengthen their ability to apply GMP principles within their workplaces to maintain compliance and support continuous improvement.

This course is suitable for new professionals entering regulated industries, as well as experienced personnel seeking to update their knowledge, close competency gaps, or improve compliance performance.

Course Objectives

By the end of this course, participants will be able to:

1. Understand the fundamental principles and regulatory expectations of Good Manufacturing Practice.

2. Identify and interpret global GMP regulatory requirements (WHO, FDA, EU, ISO, PIC/S, etc.).

3. Understand the structure and functions of an effective GMP-compliant Quality Management System (QMS).

4. Apply GMP requirements to manufacturing operations, facility and equipment management, documentation, and record-keeping.

5. Recognize common sources of GMP non-compliance and implement strategies to mitigate them.

6. Strengthen quality culture and promote continuous improvement in regulated manufacturing environments.

7. Ensure production processes consistently deliver safe, effective, and high-quality products.

8. Enhance audit readiness and contribute to successful internal and external regulatory inspections.

Course Outline

Module 1: Introduction to Good Manufacturing Practice

• What is GMP? Purpose and scope

• History and evolution of GMP regulations

• Key regulatory bodies (FDA, WHO, EU, PIC/S, ISO)

• Principles of quality, safety, efficacy, and consistency

Module 2: Quality Management System (QMS) in GMP

• Quality system framework and components

• Quality risk management (ICH Q9)

• Change control and deviation management

• CAPA (Corrective and Preventive Actions)

• Internal audits and continuous improvement

Module 3: Personnel and Training Requirements

• Roles and responsibilities in GMP environments

• Personnel hygiene and gowning

• Training and competency management

• Good documentation practices for personnel

Module 4: Documentation and Record Management

• Good Documentation Practice (GDP) principles

• Data integrity: ALCOA+

• Batch records, SOPs, logbooks, and controlled documents

• Electronic records and regulatory expectations

Module 5: Premises, Facilities, and Equipment

• Facility layout and workflow design

• Cleanroom classifications and environmental controls

• Equipment qualification (IQ/OQ/PQ)

• Calibration, maintenance, and cleaning validation

Module 6: Production and Process Controls

• Raw material management and supplier qualification

• Process validation and monitoring

• In-process controls and sampling

• Prevention of contamination, mix-ups, and cross-contamination

• Packaging and labeling control requirements

Module 7: Quality Control (QC) and Laboratory Practices

• QC testing and compliance requirements

• Laboratory safety and data integrity

• Method validation and analytical controls

• Handling of out-of-specification (OOS) results

Module 8: GMP for Storage, Distribution, and Supply Chain

• Warehousing requirements and conditions

• Good Distribution Practice (GDP) overview

• Temperature control, tracking, and traceability

• Product recall, returns, and complaint handling

Module 9: GMP Audits and Regulatory Inspections

• Types of inspections (internal, supplier, regulatory)

• Preparing for audits

• Inspection conduct and communication

• Responding to audit observations and non-conformance

Module 10: Case Studies and Practical Scenarios

• Real GMP non-compliance case analyses

• CAPA development exercise

• Documentation practice workshop

• Facility and process evaluation exercises

Learning Outcomes

Upon completion of the GMP Training Course, participants will be able to:

1. Confidently apply GMP principles to maintain compliance in daily operations.

2. Implement effective quality systems and contribute to a culture of continuous improvement.

3. Prepare, review, and maintain accurate GMP documentation.

4. Identify non-conformities and participate in root cause analysis and CAPA implementation.

5. Enhance operational reliability, reduce errors, and minimize compliance risks.

6. Support readiness for GMP inspections and effectively respond to regulatory observations.

7. Ensure that products are consistently manufactured to meet required quality and safety standards.

8. Communicate GMP requirements to team members and contribute to cross-functional quality initiatives.