Abstract

USE OF DECISION TREE TO IMPLEMENT GMP: MAINTAIN THE STATE OF READINESS FOR QUALITY AUDIT

Md Rehan Alam and Sunil Gupta*

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Abstract

Good Manufacturing Practices (GMP) is a collection of standards, norms and recommendations for the production of drug substances and drug products, as well as medical devices. It aims to maintain the standards laid by the regulatory agencies throughout the world such as U. S. Food & Drug Administration, Therapeutic Goods Administration, European Medicines Agency, Medicines and Health products Regulatory Agency, International Council for Harmonisation to provide quality products to the general population of the world at continuous and reproducible pace. Drug product manufacturing is a complex process involving raw materials (Active Pharmaceutical Ingredient, excipient, solvents), packaging materials, manufacturing equipment, laboratory glassware, manpower and transportation that are prone to potential risks. The quality risk could be attributed to any of the steps of product manufacturing and could impose serious threat to quality of the drug product. To overcome these risks, audits are conducted (internal and external). Audits are time consuming and are thought to be troublesome by the smallscale industry due to lack of experience, manpower and economical constraints which results in regulatory non-compliance. This review discusses the practices to make audit easy, convenient and reliable to industrialists. The decision tree approach could be easily understood and followed to maintain the state of readiness for a quality audit.

Keywords: Good Manufacturing Practice, Quality risk, Quality audit, Training, Decision Tree.