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

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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.