WHO publishes Notice of Concern regarding GMP Deviations about two Manufactures located in India

The WHO Notices of Concern are very similar to FDA Warning Letters. These letters are issued  to a manufacturer, contract research organization or quality control laboratory by the WHO Prequalification of Medicines Programme - usually after an inspection was performed at a site where observations were made that result in concerns regarding compliance of the site with specified standards such as Good Manufacturing Practices (GMP), Good Clinical Practices (GCP) or Good Laboratory Practices (GLP).

Like with the FDA Warining Letters a Notice of Concern is published on the internet. The letters contain observations made during an inspection that are considered to be "critical" or "major" non-compliances with WHO norms and standards, that are of concern in relation to quality management or quality assurance; or "critical" or "major" non-compliances with WHO norms and standards that were not satisfactorily addressed in the response from the company to an inspection.

If WHO identifies a public health risk, appropriate additional steps are taken to advise the public.  These steps may include:

  • Suspension of products on the "List of prequalified products"; (See Notice of Suspension)
  • Recall of batches of products on the "List of prequalified products" that had been supplied by a manufacturer;
  • Rejection of applications submitted for assessment to the Prequalification Programme.

The new Notice of Concern letters have been published on 11 May 2011 and 8 June 2011. Both manufacturers are located in India.

Amsal Chem Private Ltd (11 May 2011), Gujarat - INDIA

This Notice of Concern contains findings related to failures to ensure that appropriate laboratory controls were in place (e.g. Audit trail for HPLC) and inadequate validation documentation.

Themis Medicare Limited (8 June 2011), Gujarat - INDIA

This Notice of Concern contains critical and major findings about the handling of deviations and failures to appropriately ensure the quality of key material (APIs) before being used in the manufacture of the medicinal products.

Source: WHO Website 

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