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

The QRM or Enablers are a fundamental feature of the regulatory bodies for a quality product. In the US, during the Mexican-American War of 1846–1848, many deaths occurred. The reason was not a slaughter scene in wartime only, but also due to a lack of safety and efficacy of imported drugs. The United States Import Drug Act 1848 was authorized for testing and assuring the safety and purity of imported drugs before crossing the border. The modern finding of risk management for drug and biological products arose with a 1999 risk management report to the Food and Drug Administration (FDA) Commissioner by Task Force. A conception for proactive risk management including internal Risk and external Risk was approved in August 2002 with the declaration of a new Food and Drug Administration proposal entitled “Pharmaceutical cGMPs for the 21st CenturyA Risk-based approach”. In September 2004, the conclusive report on the FDA proposal emerged. The report foretold that industry and FDA should adopt the quality systems model for quality management and regulations.1 The olden ways to assure quality in product and process are Trends review, Changes review, Flow charts, Checklists, Observation compilations (Complaints, Deviations, etc.). Now quality risk management ground rules are implemented across the industry with the help of predictable QRM or Enabler tools hold up with statistical tools. THE QUALITY RISK MANAGEMENT ICH states that “Quality Risk Management (QRM) is a systematic process for the assessment, control, communication, and review of risk to the quality of the medicinal product across the product lifecycle.3 The entire ICH-Q9 guideline is devoted to quality risk management as QRM or enablers play an important role in producing a quality product. QRM or Enablers ascertain that the quality risk evaluation is based on customary comprehension, absolute process awareness, and eventually keeping patients safe. QRM or Enablers could be a proactive or retrospective strategy.