scholarly journals An Overview of Risk Management and Risk-based Cleaning Validation

2020 ◽  
Vol 11 (4) ◽  
pp. 5407-5414
Author(s):  
Sumukha Krishna P ◽  
Gangadharappa H V ◽  
Nagendra S ◽  
Hemanth Kumar S
Keyword(s):  
Risk Management ◽  
Pharmaceutical Industry ◽  
Product Quality ◽  
Modern Approach ◽  
Quality Risk Management ◽  
Cleaning Validation ◽  
Cleaning Procedures ◽  
Product Quality And Safety ◽  
Quality Risk ◽  
Quality Policy

Risk in general means exposure to harm or a factor that can contribute towards bringing harm to a system. Almost every operation in the pharmaceutical industry is susceptible to risks. There is a need to overcome risks and them to prevent unwanted changes in product quality and safety. This prevention can be done by carrying out quality risk management (QRM) that facilitates the proper of risks, risk analysis, risk assessment to control and reduce risks. ICH Q9 guidelines explain quality risk management and its applications in the pharmaceutical industry. Cleaning validation is performed to verify and evaluate the efficacy of cleaning procedures used to clean the equipment after production and to prevent cross-contamination between products that are manufactured in the production facility. current study on reviews of quality risk management and cleaning validation policies. By incorporating QRM in the quality policy, companies can look to improve the modern Approach towards facing risks related to the issues that affect the product quality, safety and compliance concerning the cleaning of equipment used in manufacturing and supporting operations in the industries.

Quality Risk Management: State of the Industry—Part 1. Has the Industry Realized the Full Value of ICH Q9?

2014 ◽  
Author(s):  
Anne Greene ◽  
◽  
Kelly Waldron ◽  
Nuala Calnan
Keyword(s):  
Risk Management ◽  
Patient Safety ◽  
Product Quality ◽  
Quality Risk Management ◽  
Current State ◽  
Quality And Patient Safety ◽  
Quality Risk

This paper summarizes research designed to characterize the current state of pharmaceutical and biotechnology industries with respect to the adoption of Quality Risk Management as per ICH Q9. The research supports the hypotheses that the full value of QRM with respect to product quality and patient safety has not yet been realized. In addition, industry appears to be lagging behind regulatory expectations with respect to QRM maturity, indicating that current approaches to QRM require significant improvement.

scholarly journals Impact of Quality Risk Management Process in Pharmaceutical Industry to Curtail the Non Conformity

2013 ◽  
Vol 11 (01) ◽  
pp. 74-82
Author(s):  
Aachchhadita Sharma ◽  
Raju Mari Jeyaprakash ◽  
Raju Mari Jeyaprakash ◽  
Rinchi Bora ◽  
Abinash Chandra
Keyword(s):  
Risk Management ◽  
Risk Mitigation ◽  
Drug Product ◽  
Management Process ◽  
Ground Rule ◽  
Quality Risk Management ◽  
Risk Management Process ◽  
Regulatory Bodies ◽  
Quality Risk ◽  
Risk Scale

Risk is intertwined with every drug product in a market. This article’s intent is to provide ground rule and praxis of different tools for Quality Risk Management (QRM) in various aspects of pharmaceutical science. QRM comprises of tools and processes which helps in establishing objectives. Hence they are also known as Enablers. Enablers help in risk mitigation of product quality throughout a lifecycle in such a way that benefit outweighs the risk. The key properties of Enablers or QRM, i.e., attempts made, solemnness and records shall be compatible with risk scale. The Enablers accomplishment gives recognized, obvious and steps of Enabler process produced by regeneratable methods which is based on customary comprehension to evaluate feasibility, ability to find out risk prejudice. The QRM or Enabler tools can assist the manufacturing company and regulatory bodies to scrutinize, handle, notify, and inspect the risk.

ICH Q9 Quality Risk Management

2017 ◽  
pp. 579-610 ◽  
Author(s):  
David Elder ◽  
Andrew Teasdale
Keyword(s):  
Risk Management ◽  
Quality Risk Management ◽  
Quality Risk

Quality Risk Management

2015 ◽  
pp. 423-434
Author(s):  
Yvonne Bouwman-Boer ◽  
Lilli Møller Andersen
Keyword(s):  
Risk Management ◽  
Quality Risk Management ◽  
Quality Risk

Identifying and assessing highly hazardous drugs within quality risk management programs

2016 ◽  
Vol 79 ◽  
pp. S11-S18 ◽  
Author(s):  
Robert G. Sussman ◽  
Anthony R. Schatz ◽  
Tracy A. Kimmel ◽  
Allan Ader ◽  
Bruce D. Naumann ◽  
...  
Keyword(s):  
Risk Management ◽  
Quality Risk Management ◽  
Quality Risk ◽  
Hazardous Drugs

Quality Risk Management-Based AQbD Approach to Development of VEER Chromatography Method for the Estimation of Multiple Combined Formulations of Anti-Hypertensive Drugs

2020 ◽  
Author(s):  
Pintu B Prajapati ◽  
Mukti A Thakor ◽  
Kunjan B Bodiwala ◽  
Shailesh A Shah
Keyword(s):  
Risk Management ◽  
Dosage Forms ◽  
Simultaneous Estimation ◽  
Chromatography Method ◽  
Pharmaceutical Dosage Forms ◽  
Quality Risk Management ◽  
Screening Design ◽  
Quality Risk ◽  
Quality By Design Approach ◽  
Risk Parameters

Abstract Background A number of chromatography methods for estimating combined dosage forms of telmisartan have been published in the literature, but each combined dosage form needs separate chromatography conditions for analysis. Objective The versatile, economical, eco-friendly, and robust chromatographic method has been developed for simultaneous estimation of multiple combined pharmaceutical dosage forms of anti-hypertensive drugs using the analytical quality by design approach based on principles of quality risk management (QRM) and design of experiment (DoE). Method Analytical QRM was performed by identifying probable method risk parameters and risk assessment for the development of the method. DoE was performed by Taguchi Orthogonal Array (OA)  screening design and Box-Behnken response surface design using Design-Expert software (trial version). Chromatographic separation was performed using silica gel 60 GF254 as stationary phase and toluene:ethyl acetate:methanol:glacial acetic acid (5.5 + 2 + 1 + 0.2, v/v/v/v) as a mobile phase keeping saturation time of 15 min. The developed method was applied for the assay of six combined pharmaceutical dosage forms of anti-hypertensive drugs. Results The developed method was found to be validated for accuracy, precision, specificity, linearity, LOD, LOQ, and robustness as per ICH guideline. The results of the assay were found in good agreement with the labelled claim. Conclusions The developed method can be applied for analysis and quality control of multiple combined dosage forms of telmisartan. Highlights A QRM and DoE-based AQbD approach was applied for development of chromatography method for simultaneous estimation of multiple combined dosage forms of telmisartan. The developed method was successfully applied for simultaneous estimation of six different multiple combined dosage forms of temisrtan.

Sign in / Sign up

Export Citation Format

Share Document