GMP is a set of guidelines that helps ensure that pharmaceutical products are consistently produced and controlled according to quality standards. In this blog post, we'll be diving into the essential guide to GMP for pharmaceutical professionals, covering its 20 key principles. From manufacturing to quality control, we'll explore each principle in an easy-to-understand manner. This will provide you with a comprehensive understanding of GMP and its significance in the pharmaceutical industry. So, let's get started!
1. Quality Management
Establish a quality management system to ensure that products meet the requirements of GMP regulations.
Responsibility: The Quality Control and Quality Assurance departments are responsible for quality management.
Activities:
2. Personnel
Ensure that personnel are adequately trained and qualified for their roles and that they understand their responsibilities under GMP regulations.
Responsibility: The Human Resources department is responsible for personnel management.
Activities:
3. Contracts
Establish procedures for qualifying suppliers and contracts to ensure that they comply with GMP requirements.
Responsibility: The purchase and legal departments are responsible for contract management.
Activities:
4. Purchasing
Establish procedures for purchasing, receiving, and storing materials to ensure that they comply with GMP requirements.
Responsibility: The Purchasing department is responsible for procurement management.
Activities:
5. Premises and Equipment
Establish procedures for maintaining premises and equipment to ensure that they comply with GMP requirements.
Responsibility: The Engineering and Maintenance departments are responsible for premises and equipment management, including calibration.
Activities:
6. Documentation
Establish procedures for document control to ensure that all documents related to GMP compliance are properly maintained.
Responsibility: The Document Control department is responsible for documentation management.
Activities:
7. Production
Establish procedures for production to ensure that all products meet GMP requirements.
Responsibility: The Production department is responsible for manufacturing management.
Activities:
8. Quality Control
Establish procedures for quality control to ensure that products meet all GMP requirements.
Responsibility: The Quality Control department is responsible for quality testing and control.
Activities:
9. Complaints
Establish procedures for handling customer complaints related to product quality.
Responsibility: The Quality Assurance department is responsible for managing complaints and recalls.
Activities:
10. Recall
Establish procedures for conducting product recalls in case of product quality issues.
Responsibility: The Quality Assurance department is responsible for managing complaints and recalls.
Activities:
11. Self-Inspection
Establish procedures for conducting self-inspections to identify potential GMP compliance issues.
Responsibility: The Quality Assurance department is responsible for conducting self-inspections.
Activities:
12. Continuous Improvement
Establish procedures for continuous improvement to ensure that the quality management system is effective and efficient.
Responsibility: Management, production and quality assurance departments are responsible for maintaining, monitoring, and continuously improving the quality management system.
Activities:
13. Management
Ensure that senior management is committed to GMP compliance and that they provide resources for the implementation of the quality management system.
Responsibilities: Senior management is responsible for establishing policies, administration, communication, listening, and providing resources.
Activities:
14. Risk Assessment
Conduct risk assessments to identify potential compliance issues and to develop appropriate risk mitigation measures.
Responsibility: The Quality Assurance department is responsible for risk management.
Activities:
15. Change Control
Establish procedures for managing changes to processes, equipment, or facilities to ensure that they comply with GMP requirements.
Responsibility: The Quality Assurance department is responsible for change control.
Activities:
16. Qualification & Validation
Establish procedures for validating processes, equipment, and facilities to ensure that they meet GMP requirements.
Responsibility: The Quality Assurance and Engineering departments are responsible for validation.
Activities:
17. Calibration
Establish procedures for calibrating equipment to ensure that it functions properly and accurately.
Responsibility: The Engineering and Maintenance departments are responsible for calibration.
Activities:
18. Cleaning & Sanitation (Hygiene)
Establish procedures for maintaining proper hygiene in all GMP compliance areas.
Responsibility: The Production and Maintenance departments are responsible for cleaning and sanitation.
Activities:
19. Training
Establish procedures for providing training to all personnel on GMP compliance requirements.
Responsibility: The Human Resources and Quality Assurance departments are responsible for training.
Activities:
20. Audit
Establish procedures for conducting internal and external audits to ensure GMP compliance.
Responsibility: The Quality Assurance department is responsible for auditing.
Activities:
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21. Material Handling & Storage
Responsibility: The Production and Warehouse departments are responsible for material handling and storage.
Activities:
22. Sampling & Testing
Responsibility: The Quality Control department is responsible for sampling and testing.
Activities:
23. Records & Management
Responsibility: The Document Control department is responsible for records management.
Activities:
Summary
Good Manufacturing Practices (GMP) are the standards used to ensure that products are consistently manufactured to the highest quality and safety specifications. The 20 golden rules of GMP provide a framework for businesses to follow in order to create and maintain a safe and effective production environment. Professionals in the field can expand this list further to remain current with the changing regulatory environment and to adopt the current best practices (cGMP, Pharmaceutical Quality System (PQS), etc.). The list is not in perfect order; however, all items are of significant importance and considerably impact processes and controls!
Disclaimer: The views and opinions expressed on PharmaRead are those of the authors and do not necessarily reflect the official policy or position of any agency or organization. PharmaRead articles are provided for information only with a focus on global health, pharmacy practice, and healthcare systems in Low- and Middle-income Countries (LMICs). Readers should seek expert opinion for use, implementation or application of this knowledge based on their individual circumstances.