The Essential Guide to GMP for Pharmaceutical Professionals: An Introduction to Its 20 Key Principles

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:

• Establishing and maintaining quality systems.
• Developing and implementing procedures to ensure consistent product quality.
• Conducting risk assessments to identify potential quality issues.
• Conducting audits.
• Establishing a process for monitoring and evaluating the effectiveness of quality management system.
• Defining quality assurance procedures.

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:

• Conducting regular training sessions for all employees on GMP requirements.
• Ensuring that personnel are aware of the importance of maintaining product quality and safety.
• Establishing procedures for assessing the competency and performance of personnel.
• Maintaining personnel records (e.g., training records/retraining and assessment results).

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:

• Defining contract terms and conditions.
• Reviewing and negotiating contracts with suppliers and customers.
• Conducting audits of suppliers to ensure that they meet GMP requirements.
• Reviewing contracts to ensure that they contain provisions related to GMP compliance.
• Establishing procedures for addressing non-compliance issues with suppliers.

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:

• Sourcing raw materials, packaging materials, and consumables, selecting suppliers, and conducting vendor audits.
• Ensuring that all materials are properly labeled and identified.
• Conducting regular inspections of storage areas to ensure that materials are stored in proper conditions.
• Establishing procedures for addressing material non-conformance issues.

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:

• Maintaining facilities and equipment, ensuring that they are in compliance with GMP regulations.
• Conducting regular maintenance of equipment to ensure that it functions properly.
• Ensuring that premises are kept clean and free from contamination.
• Establishing procedures for addressing equipment or facility non-conformance issues.
• Implementing corrective and preventive actions.

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:

• Maintaining and updating standard operating procedures, batch records, and other GMP-related documentation.
• Ensuring that all documents are properly indexed and stored under controlled conditions.
• Establishing procedures for document revision and approval.
• Establishing procedures for document retention and disposition.

7. Production

Establish procedures for production to ensure that all products meet GMP requirements.

Responsibility: The Production department is responsible for manufacturing management.

Activities:

• Establishing and maintaining manufacturing processes, ensuring that they are in compliance with GMP regulations.
• Developing and implementing procedures for all production activities.
• Ensuring that all production activities are supervised and monitored.
• Establishing procedures for addressing production non-conformance issues.
• Implementing corrective and preventive actions.

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:

• Conducting analytical testing, reviewing batch records, and releasing products for distribution.
• Conducting regular tests and inspections of products to ensure that they meet specified requirements.
• Establishing procedures for addressing quality control non-conformance issues.
• Monitoring product quality through statistical process control.

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:

•  Ensuring that all complaints are properly recorded and investigated.
• Establishing procedures for addressing complaints in a timely manner.
• Analyzing complaint data to identify trends or patterns.

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:

• Developing and implementing procedures for recall activities.
• Ensuring that all recalls are conducted in a timely and effective manner.
• Establishing procedures for tracking and monitoring recalled products.

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:

• Developing and implementing procedures for self-inspection activities.
• Conducting regular self-inspections to identify deficiencies and potential compliance issues.
• Implementing corrective actions to address identified compliance issues.

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:

• Conducting regular reviews of the quality management system to identify areas for improvement.
• Establishing procedures for implementing corrective and preventive actions.
• Establishing procedures for implementing changes to the quality management system.

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:

• Ensuring that senior management provides adequate resources for GMP compliance activities.
• Ensuring that senior management is involved in decision-making related to GMP compliance.
• Encouraging senior management to lead by example in promoting GMP compliance.

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:

• Conducting risk assessments for all critical GMP compliance areas.
• Identifying potential risks and developing appropriate risk mitigation measures.
• Establishing procedures for monitoring and evaluating the effectiveness of risk mitigation measures.

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:

• Reviewing and approving changes to facilities, equipment, processes, and documentation.
• Establishing procedures for documenting and approving change requests.
• Conducting risk assessments of proposed changes to identify potential compliance issues.
• Ensuring that all changes are properly evaluated and tested before implementation.

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:

• Establishing and maintaining validation programs, performing validation studies, and reviewing validation protocols and reports.
• Developing and implementing procedures for process validation.
• Conducting equipment and facility qualification.
• Ensuring that all validation activities are properly documented and approved.

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:

• Calibrating equipment, maintaining calibration records, and implementing corrective and preventive actions.
• Developing and implementing procedures for equipment calibration.
• Ensuring that all equipment is calibrated on a regular basis.
• Conducting tests and inspections of calibrated equipment to ensure that it functions properly.

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:

• Developing and implementing cleaning and sanitation procedures, monitoring cleaning activities, and conducting validation studies.
• Ensuring that personnel are properly trained and follow the defined procedures for cleanliness and material handling.
• Conducting regular cleaning and sanitizing of all GMP-compliant areas.
• Establishing procedures for addressing hygiene non-conformance issues.
• Implementing corrective and preventive actions.

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:

• Providing GMP training to employees, identifying training needs, and monitoring training effectiveness.
• Developing and implementing training plans for all personnel.
• Ensuring that all personnel receive regular training on GMP compliance requirements.
• Conducting regular assessments of personnel competency.

20. Audit

Establish procedures for conducting internal and external audits to ensure GMP compliance.

Responsibility: The Quality Assurance department is responsible for auditing.

Activities:

• Developing and implementing audit plans for all GMP compliance areas.
• Conducting regular internal audits to identify potential compliance issues.
• Conducting external audits of suppliers and contractors to ensure compliance with GMP requirements.
• Providing recommendations on audit findings, implementing corrective and preventive actions.

.… and More

21. Material Handling & Storage

Responsibility: The Production and Warehouse departments are responsible for material handling and storage.

Activities:

• Storing materials in appropriate conditions.
• Handling materials according to GMP regulations and preventing cross-contamination.

22. Sampling & Testing

Responsibility: The Quality Control department is responsible for sampling and testing.

Activities:

• Collecting samples, conducting tests, and releasing products for distribution.

23. Records & Management

Responsibility: The Document Control department is responsible for records management.

Activities:

• Developing and maintaining record retention policies.
• Maintaining data integrity.
• Controlling and authorizing access to records.
• Ensuring that records are complete and accurate.
• Protecting records from damage or loss.

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.