Professional Diploma Course | Duration: 6 Months

 Course Introduction

Good Manufacturing Practices (GMP) are essential quality assurance principles and operational requirements designed to ensure that products are consistently manufactured, controlled, stored, and distributed according to established quality and safety standards.

GMP plays a critical role in pharmaceutical, food and beverage, cosmetics, medical devices, chemical, and other manufacturing industries. It establishes systematic controls over personnel, premises, equipment, raw materials, production processes, sanitation, documentation, quality control, and product handling to minimize contamination, mix-ups, errors, and product defects.

In Bangladesh, GMP compliance is particularly important for organizations operating in regulated manufacturing sectors. Relevant regulatory requirements may include applicable provisions of the Bangladesh Drugs and Cosmetics Act, 2023, Bangladesh Food Safety Act, 2013, Bangladesh Standards and Testing Institution (BSTI) requirements, and other sector-specific regulations and guidelines.

This six-month professional diploma programme is designed to provide participants with comprehensive knowledge and practical competencies in GMP principles, hygiene and sanitation, facility management, equipment control, production practices, quality assurance, documentation, validation, deviation management, CAPA, and GMP auditing.

The programme also introduces internationally recognized GMP guidelines and quality management principles, including WHO GMP, PIC/S GMP, relevant EU GMP principles, ISO 9001, and applicable food safety and pharmaceutical quality requirements.

Through structured learning, industrial case studies, practical exercises, assignments, and viva voce assessments, participants will develop the competencies required to support GMP implementation, monitoring, and continual improvement in manufacturing facilities.

Course Objectives

The main objectives of this programme are to:

• Understand the fundamentals, principles, and importance of Good Manufacturing Practices.
• Develop knowledge of national and international GMP requirements.
• Understand GMP requirements for personnel, premises, equipment, and production processes.
• Apply good hygiene, sanitation, and contamination prevention practices.
• Understand raw material handling, storage, production, and finished product control.
• Develop knowledge of documentation and record management.
• Understand quality assurance and quality control systems.
• Apply deviation management, change control, and CAPA principles.
• Understand process validation, equipment qualification, and calibration.
• Develop practical skills in GMP inspection, compliance monitoring, and auditing.

Course Outcomes

After successful completion of the programme, participants will be able to:

• Explain the fundamental principles and requirements of GMP.
• Identify GMP compliance risks in manufacturing facilities.
• Evaluate personnel hygiene and sanitation practices.
• Understand facility layout, equipment, and environmental control requirements.
• Apply basic GMP controls in material handling and manufacturing operations.
• Understand batch manufacturing records and documentation practices.
• Identify contamination, cross-contamination, and product mix-up risks.
• Explain quality assurance, quality control, and product release processes.
• Understand deviation, CAPA, change control, and validation requirements.
• Conduct basic GMP inspections and compliance assessments.
• Support the implementation and continual improvement of GMP systems.

Course Modules

Module 1: Fundamentals of Good Manufacturing Practices

Module Contents:

1. Introduction to Good Manufacturing Practices (GMP): Concepts, Objectives and Importance
2. Principles of GMP and Their Application in Manufacturing Industries
3. Overview of WHO GMP, PIC/S GMP and Relevant International Guidelines
4. GMP Regulatory Framework and Sector-Specific Compliance Requirements in Bangladesh
5. Quality Management Principles, Quality Culture and Management Responsibilities
6. GMP Roles and Responsibilities of Production, Quality Assurance and Quality Control Departments

Assessment Requirements:

• Assignment Submission
• Viva Voce Test

Module 2: GMP Requirements for Personnel, Premises and Equipment

Module Contents:

1. Personnel Qualification, Training, Competency and Hygiene Requirements
2. Personal Protective Equipment (PPE), Gowning and Personnel Entry Procedures
3. GMP Facility Design, Layout, Building Maintenance and Material Flow
4. Equipment Selection, Installation, Cleaning, Maintenance and Identification
5. Environmental Control: Temperature, Humidity, Ventilation and Air Quality
6. Prevention of Contamination, Cross-Contamination and Product Mix-ups

Assessment Requirements:

• Assignment Submission
• Viva Voce Test

Module 3: GMP in Material Handling and Manufacturing Operations

Module Contents:

1. Supplier Qualification, Raw Material Purchasing and Material Approval
2. Receipt, Sampling, Identification, Quarantine and Storage of Materials
3. Material Dispensing, Weighing, Handling and Issuance Controls
4. GMP Requirements for Manufacturing Processes and In-Process Controls
5. Packaging, Labelling, Batch Identification and Finished Product Handling
6. Warehouse Management, Stock Rotation, Product Traceability and Distribution Controls

Assessment Requirements:

• Assignment Submission
• Viva Voce Test

Module 4: Quality Assurance, Quality Control and GMP Documentation

Module Contents:

1. Fundamentals of Quality Assurance (QA) and Quality Control (QC)
2. GMP Documentation System: SOPs, Work Instructions, Forms and Records
3. Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR)
4. Sampling, Inspection, Laboratory Testing and Product Quality Evaluation
5. Product Release, Rejection, Retention Samples and Stability Management
6. Document Control, Data Integrity, Good Documentation Practices (GDP) and Record Retention

Assessment Requirements:

• Assignment Submission
• Viva Voce Test

Module 5: GMP System Management, Validation and Corrective Actions

Module Contents:

1. Deviation Management, Non-Conformity Reporting and Investigation
2. Corrective and Preventive Action (CAPA) Management
3. Change Control and Impact Assessment
4. Process Validation, Cleaning Validation and Equipment Qualification
5. Calibration, Preventive Maintenance and Utility System Management
6. Product Complaints, Product Recall and Risk-Based Quality Management

Assessment Requirements:

• Assignment Submission
• Viva Voce Test

Module 6: GMP Inspection, Auditing and Continual Improvement

Module Contents:

1. GMP Inspection Principles, Preparation and Inspection Methodology
2. Internal GMP Auditing: Audit Planning, Checklists and Evidence Collection
3. Identification of GMP Deficiencies, Critical Findings and Compliance Gaps
4. GMP Audit Reporting, Corrective Action Plans and Follow-Up Verification
5. Regulatory Inspection Readiness and Management of Inspection Observations
6. GMP Performance Monitoring, Management Review and Continual Improvement

Assessment Requirements:

• Assignment Submission
• Viva Voce Test

Course Methodology

The programme will be delivered through a combination of:

• Professional instructor-led training sessions.
• PowerPoint-based theoretical and technical discussions.
• Practical GMP implementation exercises.
• Manufacturing facility and process-based case studies.
• Personnel hygiene and sanitation assessment exercises.
• GMP documentation and SOP development exercises.
• Batch manufacturing record review exercises.
• Contamination and cross-contamination risk assessment.
• Deviation investigation and CAPA preparation exercises.
• GMP inspection checklist development.
• Internal audit and compliance gap assessment.
• Module-based assignments and final viva voce assessment.

Who Should Attend?

This professional diploma programme is suitable for:

• Production Managers and Production Officers.
• Quality Assurance (QA) Professionals.
• Quality Control (QC) Professionals.
• GMP Compliance Officers and Coordinators.
• Pharmaceutical Industry Professionals.
• Food and Beverage Manufacturing Professionals.
• Cosmetics and Personal Care Industry Professionals.
• Medical Device Manufacturing Professionals.
• Chemical and Industrial Manufacturing Professionals.
• Warehouse and Supply Chain Professionals.
• Laboratory and Technical Personnel.
• Internal Auditors and Compliance Auditors.
• Industrial Consultants and Quality Management Professionals.
• Graduates seeking a career in GMP and Quality Management.

Course Conclusion

Good Manufacturing Practices are fundamental to ensuring product quality, safety, consistency, and regulatory compliance. Effective GMP implementation helps organizations minimize manufacturing errors, prevent contamination, improve operational discipline, and maintain confidence in their products.

This six-month professional diploma programme provides participants with a structured understanding of GMP principles, manufacturing controls, personnel hygiene, facility and equipment management, quality assurance, documentation, validation, CAPA, and GMP auditing.

By completing this programme, participants will be better prepared to contribute to GMP implementation, conduct compliance assessments, identify manufacturing risks, and support continual improvement of quality systems in manufacturing organizations.

Course Information

• Course Title: Diploma in Good Manufacturing Practices (GMP)
• Course Type: Professional Diploma Course
• Duration: 6 Months
• Programme Structure: 6 Modules
• Assessment: Module Assignments and Viva Voce Tests
• Training Provider: Compliance Training (BD) Limited (CTBL)
• Certificate: Professional Diploma Certificate upon successful completion of the programme and applicable assessment requirements.

Compliance Training (BD) Limited (CTBL)
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