Hazard Operability Analysis (Hazop): A Quality Risk Management Tool for the Protection of Quality Drugs.
Year: 2025
Type: article
Abstract: Hazard and operability study is a systematic and structured technique which is used to identify the potential hazards and evaluate the problems associated with systems. The health ministry's largest-ever survey to assess drug quality revealed that more than 10% of medications in the government supply chain were "Not of Standard Quality" (NSQ). Comparatively, samples collected from retail locations nationwide showed an estimated 3% of NSQ medications, whereas 0.023% of the samples were determined to be fake.According to the survey, the combined prevalence of NSQ and fake medications nationwide was estimated to be 3.16% and 0.0245% for both government and retail sources."In India, the estimated percentage of NSQ drugs from official sources was 10.02%, while the percentage of spurious drugs was 0.059%." The following pattern was noted in civil hospital shops during the examination of samples from the government supply chain that were deemed NSQ: 10.44% NSQ, ESI dispensaries, 11.03% NSQ, state government medical store depots CGHS dispensaries: 4.11% NSQ and 9.01% NSQ, according to a National Institute of Biologicals (NIB) survey conducted in Noida.States like Meghalaya, Mizoram, Arunachal Pradesh, Nagaland, Telangana, Uttarakhand, Uttar Pradesh, and Punjab had higher NSQs (11.39– 17.39%) in terms of the government supply chain, whereas Chandigarh, Delhi, Orissa, Tamil Nadu, and West Bengal had lower NSQs (0–7.93%).The country's retail establishments were projected to have a 3% and 0.023% NSQ and bogus medication proportion, respectively.Tools for Quality Risk Management (QRM) are crucial for detecting and reducing these risks, but the pharmaceutical industry has yet to fully utilize Hazard Operability Analysis (HAZOP), a methodical and structured approach that has long been employed in the chemical and processing industries. The potential of HAZOP as a proactive QRM tool to pinpoint manufacturing failure spots for non-standard quality medications is assessed in this study. CAPA Is also applied to the risk to identify the cause. Keywords: Consequence, Medications, Survey ,CAPA ,Examination , Methodical
Authors: Sayantani Dey Sayantani Dey, Tapan Kumar Chaudhuri Tapan Kumar Chaudhuri
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4410538297