Quality Risk Management (QRM) of active pharmaceutical ingredients during transportation by using FMEA tools and methodology

  • Posted on: 30 September 2017
  • By: admin

 

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October 2017 ARTICLE LIST >>

PharmaTutor (October - 2017)

 

ISSN: 2347 - 7881
(Volume 5, Issue 10)

 

Received On: 16/06/2017; Accepted On: 23/06/2017; Published On: 01/10/2017

 

AUTHORS:
Upendra Kumar Singh*, Sammer Rastogi, Manish Kumar Yadav
School of Pharmacy,
Lloyd Institute of Management and Technology,
Greater Noida, 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”. .

 

 

How to cite this article: Singh UK, Rastogi S, Yadav MK; Quality Risk Management (QRM) of active pharmaceutical ingredients during transportation by using FMEA tools and methodology; PharmaTutor; 2017; 5(10); 23-29

 

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