• Institute of Good Manufacturing Practices India
  • Global accredited training & certification provider
  • Approved by Quality Council of India (QCI) & Accredited Vocational Institution of Ministry of HRD, Government of India
  • Approved Training Institute of Food Safety and Standards Authority of India (FSSAI)
  • Recognized by Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, Government of India
  • An ISO 9001:2015 Certified Organisation registered under The Societies Registration Act,1860 Government of India
  • Empanelled under Ministry of Horticulture and Food Processing, Government of Uttar Pradesh
  • Affiliated with Life Sciences and Food Industry Sector Skills Council (SSC) set up by National Skill Development Corporation (NSDC)
  • Conferred with QUALITY COUNCIL OF INDIA (QCI) – D.L. SHAH NATIONAL QUALITY AWARD & ASSOCHAM Services Excellence Award 2017

Trusted by organizations & training participants in over 30 countries
Training | Certification | Education | Research


The Lupin’s Tarapur API facility received one observation on account of cGMP deficiency

Lupin is India’s third largest drug manufacturing company. The Tarapur API manufacturing facility of Lupin has received one observation by USFDA. The Tarapur facility produces fermentation based APIs. USFDA conducted the inspection of the site from 27th August to 31ST August. The inspection was carried out by three USFDA inspectors. One observation related to procedural deficiency was cited by the investigators. The investigators during the inspection were focused on cGMP compliance and also on the safety of Lupin’s Valsartaan, Losartan and Irbesartan APIs, commonly known as Sartans ;). This was due to safety alert issued by Regulatory Authorities on the NDMA (N-Nitrosodimethylamine, a potent human carcinogen) impurity in Valsartan API supplied by some companies. After the inspection, USFDA investigators found that the manufacturing processes of Lupin’s Sartans are safe with no chance of presence of the NDMA impurity in the APIs.