Good Manufacturing Practice (GMP)
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This document discusses Good Manufacturing Practices (GMP) for pharmaceutical products as outlined by the World Health Organization (WHO). It provides definitions and explanations of key GMP concepts including quality assurance, quality management, and ensuring consistent production of pharmaceuticals according to appropriate quality standards. It also discusses WHO involvement in establishing GMP guidelines and differences between GMP and current Good Manufacturing Practice (cGMP). The document outlines basic GMP principles for quality management, sanitation, qualification and validation, complaints and recalls, and more. It emphasizes that quality failures can result in regulatory warnings, market withdrawals, supply disruptions, and loss of credibility with patients and regulators.
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Good Manufacturing Practice (GMP)
- 4. Good manufacturing practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.
- 5. ■part of quality assurance ■ensures that products are consistently produced and controlled ■quality standards appropriate to their intended use ■as required by the marketing authorization
- 6. Why is the WHO involved in GMP? GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production, which may broadly be categorized in two groups: cross contamination/mix-ups false labelling Above all, manufacturers must not place patients at risk due to inadequate safety, quality or efficacy; for this reason, risk assessment has come to play an important role in WHO quality assurance guidelines.
- 7. WHO GMP versus WHO cGMP At the most basic level, GMP stands for Good Manufacturing Practice and cGMP stands for current Good Manufacturing Practice. Regulators seek to impress upon drug manufacturers the need for continuous improvement in their approach to product quality.
- 8. Basic Principles of GMP Quality Management Sanitation and Hygiene Qualification and Validation Complaints and Recalls Contract Production and Analysis
- 9. Basic Principles of GMP…. Contd. Self Inspection and Quality Audits Personnel Premises Equipment Materials
- 10. Basic Principles of GMP…. Contd. Documentation Good Practices in Production and Quality Control Sterile Production Active Pharmaceutical Ingredients GMP Inspections
- 11. Quality Management Objectives ■ To understand key issues in quality assurance/ good manufacturing practices/quality control. ■ To understand specific requirements on quality management and quality assurance including: Organization Procedures, processes and resources. ■ How to use Quality Management to resolve your current problems?
- 12. Quality Relationships Quality Management Quality Assurance GMP Production and Quality Control
- 13. What is Quality Management? The aspect of management function that determines and implements the “quality policy” The overall intention and direction regarding quality, as formally expressed and authorized by top management
- 14. QUALITY POLICY
- 15. GSK Quality Policy Quality is at the heart of all activities that support the discovery, supply and marketing of products to our patients and customers. Quality is critical to building trust with society and therefore, to our future business success.
- 17. Basic Elements of Quality Organization Structure Quality System Processes Procedures Resources The totality of these actions is termed “Quality Assurance”
- 18. What do Quality Failures lead to? • Regulatory Authority Warning Letters • Complaints, Market Withdrawals and Recalls • Loss of credibility with Regulator • Supply disruptions and Loss of Credibility with Patients and Customers • Huge amount of re-work – Investment of Money and Time
- 19. AND WHAT LEADS TO A QUALITY FAILURE?
- 20. An Eye Off the Ball is all it takes!! Big Mess!!
- 21. Let us see some live examples FAILURE TO HIRE RIGHT EMPLOYEES - Right mix of experience and qualification - Relevant to current product line - Technical knowledge - Attention to detail - Understand the cGMP principles - Make others realize value of GMP
- 23. Do the Production and Quality Assurance Personnel have adequate knowledge?
- 24. FAILURE TO MAINTAIN ADEQUATE FUNDS - GMP requires resources – defined budget, fund allocation - Materials, processes are expensive - Cannot be commanded at gunpoint - Technical staff need to emphasise the importance to senior management - Technical Staff at senior levels - May be a challenge in family owned businesses
- 26. Your response indicates that you evaluated the impact of these laboratory deviations and believe they pose a low risk. The response lacks a commitment to perform a comprehensive evaluation of your microbiology laboratory controls and practices. NEED TO DEMONSTRATE COMMITMENT TO cGMP COMPLIANCE
- 27. FAILURE TO MANAGE TIME - GMP needs to be built in ahead of production - If TIME FOR GMP = ZERO, there will be ZERO GMP. - Prioritize trainings…continuous education - Spend time in facility design evaluation and selection of the right equipments - Identify internal auditors and conduct mock audits.
- 28. Who is responsible for Quality?