. Violation-of-GMP-Principles-at-Indian-API-Manufacturing-Unit

  • 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


Violation-of-GMP-Principles-at-Indian-API-Manufacturing-Unit

Inspectors from Danish Medicines Agency inspected the facilities of Kadam Exports Private Ltd , an Indian API Manufacturers. The audit revealed severe deficiencies in the compliance with the GMP rules in virtually all areas. The active substance under scrutiny was Psyllium husk, a dietary and herbal medicinal product. The Non-compliance report was issued to the facility stating “general lack of ability to adhere to the principles of good manufacturing practices for production facilities, laboratory facilities and storage of reference and retention samples.”

In general, the Non-Compliance Reports in the EudraGMDP database are less detailed than FDA Warning Letters; however, this NCR's comments hint at the GMP deficiencies' in full detail:

  • The entire production facility is unsuitable for GMP activities; it is neither protected nor controlled, resulting in an elevated contaminationrisk.
  • The same applies to the laboratory facilities.
  • Reference and retention samples were not stored in a controlled manner.
  • The personnel is not trained in EU GMP.

Conclusively, the product quality is not up to date. There will be no recalling of batches in near future, however, the company’s GMP certificate will not be renewed. Currently, Denmark is the only EU member state in which husk by Kadam Exports Pvt Ltd has been used as API.