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

Abstract

<jats:p>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.</jats:p>

Hazards and Safety Management in Pharmaceutical Industries: A Survey of Experts' Opinion

“…The pharmaceutical business uses "Quality risk management (QRM)" as a crucial strategy to recognise, evaluate, and reduce risks that could have an influence on patient safety, product quality, and regulatory compliance. To proactively identify possible risks and put in place effective control measures, QRM frequently uses tools and methodologies like "Failure Modes and Effects Analysis (FMEA) and Hazard Analysis and Critical Control Points (HACCP)" Utilizing preventive steps to reduce risks and guarantee the quality and safety of their products, pharmaceutical businesses in India can identify key control points in their production, packaging, and distribution processes (Das et al 2014).A person's genetic makeup is used to calculate PRS, which can be used to forecast a person's propensity to develop specific diseases or experience negative drug reactions. Pharmacies in India that use PRS can evaluate the genetic risk profile of their patients and modify their pharmacological regimens as necessary to reduce the probability of negative side effects.…”

Hazard Analysis and Critical Control Points as a Quality Risk Management Tool in the Pharmaceutical Industry: A Systematic Review

“…However, many pharmaceutical organizations deem it as a whole QRM system in itself and rely solely on FMEA. 13,14 The selection of a suitable risk assessment method is an essential step in carrying out risk analysis. Although picking up the right quality risk management tool is a crucial and difficult practice but unfortunately, the guidance related to the subject is minimal.…”