QUALITY RISK MANAGEMENT (QRM) OF ACTIVE PHARMACEUTICAL INGREDIENTS DURING TRANSPORTATION BY USING FMEA TOOLS AND METHODOLOGY
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ABOUT AUTHORS
UPENDRA KUMAR SINGH*, Mr. Sammer Rastogi, Dr. Manish Kumar Yadav
*MASTER OF PHARMACY in QUALITY ASSURANCE
School of Pharmacy, Lloyd Institute of Management and Technology
Uttar Pradesh, India
* upendra.singh81@gmail.com
ABSTRACT Quality Risk Management (QRM) is a key component for access the product quality. For any pharmaceutical product, Quality Risk Management shall be applied to aim that raising the level of protection for the patient by the reduction of the risk to which that patient is exposed at the time he /she receives a drug product. This general objective can only be achieved by implemented policy of Quality Risk Management (QRM) on the product and process design and its lifecycle. The concept of risk management was first applied in the financial and insurance sectors. This concept was systematically transferred and applied in the pharmaceutical industries in 2005 with the International Conference on Harmonization (ICH) and its publication of the ICH guideline Q9 on “Quality Risk Management”. The European Commission added this guideline as Annex 20 to the EU GMP guide in March 2008. This research was explored the risk identification, risk assessment and development scientific risk control measures during transportation of API from API manufacturing site to user site (formulation plant).