Compliance

Audits

Dishman manufacture products to cGMP standards and are routinely inspected by the Indian Food and Drug Administration (IFDA) and have been inspected by the U.S. Food and Drug Administration (US FDA), EDQM (Ph. Eur.) and the Australian TGA, the World Health Organization (WHO) and the Korea Food and Drug Administration (KFDA).

GMP compliance audits

  • External: TGA (March 2010, 2012), US FDA (May 2006, 2010, 2012, 2013), EDQM (Nov. 2005) WHO (2012), KFDA (2012), India FDA annually, frequent customer audits
  • Internal: Dishman QA, routine, quarterly internal audits
  • Accreditation as foreign manufacturer for Japanese market

 

Change Management

Dishman effectively manages change by consistently registering all changes and deviations. Our system of change management helps us continuously improve our systems and processes to ensure the quality of our products and the safety of our processes. Within this system, we distinguish among:

  • Deviations: unplanned changes, short term and situation dependent
  • Changes: planned changes
  • CAPA: corrective and preventive action

News

11 August 2016
Dishman Celebrates a Decade of Success Since Acquisition of CARBOGEN AMCIS

2 February 2016
Dishman Netherlands awarded for its Corporate Social Responsibility.

24 September 2015
Dishman has been awarded manufacture of SIRTURO® (bedaquiline) API

9 February 2015
Successful FDA inspection at the Netherlands Dishman site

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