DOI: 10.21276/ajptr
Sat, 25 May 2019

Quality Risk Management: A Review

T. A. Mandhare*, P.R. Khuspe, P. S. Nangare, R. D. Vyavhare

Navsahyadri Institute of Pharmacy, Nasrapur, Pune, Maharashtra-415 213, India


In the pharmaceutical industry today, there are some examples of the use of quality risk management but, they do not represent the full contributions that risk management has to offer. Quality risk assessment is a process of identification of hazards, analysis and evaluation of the risks associated with exposure to those hazards. Risk assessment is a main part of quality risk management process. The evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the safety of the patient. For any pharmaceutical organization, quality risk management should aim at raising the level of protection for the patient, by reduction of the risk to which that patient is exposed at the time he/she receives a drug product. In the present seminar report all the aspects regarding quality, quality risk assessment and risk management are covered in great detail.

Keywords: quality, risk management, risk assessment, hazards, analysis, evaluation of risks

[PDF]   Viewed: 405   Downloaded: 95 DOI No: 10.21276/ajptr.2018.08.02.05
  • Call for paper

    American Journal of PharmTech Research (AJPTR) is a peer-reviewed, bimonthly official international journal allowing access to abstracts and full-text.



  • Email & SMS Alerts

    Email/SMS alert system is one of the key features and gives update information about the submitted manuscript.


  • Article Statastics

    American Journal of PharmTech Research (AJPTR) provides unique facility for authors to know popularity of articles on basis of numbers of PDF download and views. It will display in tabulated format.

  • Online Submission

    American Journal of PharmTech Research (AJPTR) is one of the International open access journal devoted to various disciplines in science and technology.


web counter
web counter