. Indian Pharma Stands Strong in Global markets

  • 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

Reine Lifescience gets US FDA warning letter for contravention of cGMP norms for APIs

Warning letter has been issued to Reine Life science by US Food and Drug Administration (FDA) on May 9, 2018. Reine Lifescience is a manufacturer of Active Pharmaceutical Ingredients (APIs) located in Gujarat. The warning letter summarizes significant deviations from current good manufacturing practice (cGMP) for active pharmaceutical ingredients (API).The company failed to authenticate and substantiate the appropriateness of analytical methods, as reported by the FDA officials who inspected Reine's manufacturing facility in GIDC Industrial Estate from October 30 to November 3 last year. The other findings are wrong documentation and no satisfactory control over computerized system to prevent illegal access.

The other findings are wrong documentation; the investigator found that the analytical data is stored in the folder named “PD trial”. “PD trial” folder is generally intended for product development. No satisfactory control over computerized system to prevent illegal access and also analytical system lacked controls to prevent unauthorized access to electronic data. It is also found by the investigator that the quality system does not ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs manufactured by the firm.

As a result, FDA placed an import alert 66-40 on the firm and also denies approval of any new drug applications or supplements manufactured by the firm until all the deviations are corrected.