Disregard of general GMP Principles at Indian API Facility

Recommendation

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When GMP inspectors of the Danish Medicines Agency had a closer look at the facilities of an Indian API manufacturer in December 2017, they found severe deficiencies in the compliance with GMP rules in virtually all areas. The active substance inspected was Psyllium husk, which is used in dietary and herbal medicinal products. The Non-Compliance Report to Kadam Exports Private Ltd. published a few weeks after the inspection attested to the company's "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." Generally, the Non-Compliance Reports in the EudraGMDP database are less detailed than FDA Warning Letters; still, this NCR's comments hint at the GMP deficiencies' full scale:

• The entire production facility is unsuitable for GMP activities; it is neither protected nor controlled, resulting in an elevated contamination risk.
• 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.

In conclusion: the product's quality is not ensured.

The NCR states that based on a risk analysis by the inspectors, there is no cause for recalling batches of medicines with Psyllium husk at the present time. To the Danish authority's knowledge, Denmark is the only EU member state in which husk by this manufacturer has been used as an API. However, the company's GMP certificate will not be renewed.

Source: GMP Non-Compliance Report in the Eudra GMDP Database