QUALITY RISK MANAGEMENT – CAPA TO PREVENT POTENTIAL QUALITY ISSUES
Journal Title: Asian Journal Of Pharmaceutical Research and Development - Year 2017, Vol 5, Issue 1
Abstract
In the pharmaceutical industry there are number of risks and failure involved in each and every pharmaceutical product throughout the life cycle. Risk are managed in our day to day life and ensure that preventive measures are taken to avoid any hazards in our life, similarly quality risk management is the tool using which potential quality issues can be avoided to occur for the pharmaceutical products throughout the lifecycle of the product. The principle of QRM can be applied proactively or retrospectively at many stages of pharmaceutical quality such as product development, technology transfer, production, pharmacokinetic evolution, distribution, inspection, validation, submission/review process and life cycle management in product development. It finds useful application in selection of raw materials, solvents, excipients, packaging and labelling materials, formulation development, process development and process improvement. This article discusses general principles and several tools for risk management which can be used successful to identify the potential quality issues. The quality risk management theory and applications for controlling the risk to pharmaceutical quality has identified various potential quality issues and allowed the pharmaceutical industry to manufacture the quality and safe products for the patients.
Authors and Affiliations
Sanjay Kumar Jain Jain
Keywords
Related Articles
- EP ID EP303024
- DOI -
- Views 145
- Downloads 0
3D PRINTING OF PHARMACEUTICALS –A POTENTIAL TECHNOLOGY IN DEVELOPING PERSONALIZED MEDICINE
The 3D PRINTING technology has caught the attention of medical devices industry and pharmaceutical industry due to its applications on various platform in health care industry. Even though this tech...
THALASSEMIA: A REVIEW
The thalassemia is a group of inherited hematologic disorders caused by defects in the synthesis of one or more of the hemoglobin chains. Alpha thalassemia is caused by reduced or absent synthesis of alpha globin chains,...
EBOLA VIRUS: AN OVERVIEW
Ebola virus disease (EVD), also known as Ebola hemorrhagic fever (EHF) or simply Ebola, is a viral hemorrhagic fever of humans and other primates caused by ebola viruses. Signs and symptoms typically start between two da...
ANALYTICAL METHOD DEVELOPMENT, VALIDATION AND FORCED DEGRADATION STUDIES OF LANSOPRAZOLEBY RP-HPLC
The objective of this work is to develop a rapid, precise, accurate and sensitive revere phase liquid chromatographic method and Forced degradation studies for the estimation of Lansoprazole. Th...
REDEFINING THE SCOPE OF AYURVEDA IN CARDIOLOGY
Cardiovascular diseases (CVDs) have now become the leading cause of mortality or even morbidity in India.According to the World Health Organization, cardiovascular disease causes 12 million deaths in the world...