Pharmaceutical Quality Risk Management System: Current Concept

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Author Name :- Miss Palak Sharma,,

Journal type:- NJRIP-National Journal of Research and Innovative Practices

Research Field Area :- Science And Medical Science ; Volume 1, Issue 1, No. of Pages: 14

Your Research Paper Id :- 201608028

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Abstraction :-

Every product and every process has an associated risk. Every enterprise should have a methodology for identifying and evaluating the risks it faces and it should have a process for generating intervention plans to reduce the risks to an acceptable level. This process is generally referred to as a Risk Management Plan (RMP)Pharmaceutical Industry being an important industry which is directly related to the health of people in society hence risks associated with the Pharmaceutical Industry are need to be evaluated. Every pharmaceutical product and every process has an associated risk. As per ICH Q9, Risk is defined as Combination of the probability of occurrence of harm and the severity of that harm the word “risk” is widely used in general and technical applications with different Meanings. Every product and every process has an associated risk. This article aims to provide principles and examples of tools for Quality Risk Management (QRM) that can be applied to different aspects of pharmaceutical quality. These aspects include development, manufacturing, distribution, inspection and submission of review processes throughout the lifecycle of drug substances, drug products and biological products.

Keywords :-

Quality management , risk management, FMEA, Pharmaceutical

References :-

1. Joymalya Bhattacharya, Quality Risk Management –Understanding and Control the Risk in Pharmaceutical Manufacturing Industry, International Journal of Pharmaceutical Science Invention ISSN (Online): 2319 – 6718, ISSN (Print): 2319 – 670X www.ijpsi.org || Volume 4
Issue 1|| January 2015 || PP.29-41.
2. Guidance for industry “Q9 Quality Risk Management” by US department of Health and Human Services, Food and drug Administration, Center for Drug and Evaluation Research, June 2006.
3. Implementation of ICH Q9 in the pharmaceutical field an example of methodology from PIC/S 2010.
4. WHO Guideline on Quality Risk Management A draft guidance August 2010.
5. Risk assessment and quality control by By Max Williams, MPA, November 2012.
6. Quality Risk Management- the pharmaceutical experience ann'omahony 11 november 2011.
7. prashantkumarkatiyar- International journal of pharma world research(an international quarterly pharmaceutical research journal) risk analysis and risk management in pharmaceutical industry prashant kumar katiyar; vol 1 2010.
8. kelvin CPharmaceutical engeneering; vol 28 no 3 GAMP 5- A Quality Risk Management Approach may/june 2008.
9. V Vijayakumar Reddy*, N Vishal Gupta, H V Raghunandan, U Nitin Kashyap, Quality Risk Management in Pharmaceutical Industry: A Review, International Journal of PharmTech Research CODEN (USA): IJPRIF ISSN : 0974-4304 Vol.6, No.3, pp 908-914, July-Aug 2014.