Novartis’ generics subsidiary Sandoz has been hit by a warning from the World Health Organisation about a lack of compliance at one of its manufacturing plants in South Africa.
The Financial Times has reported that WHO officials have recommended suspending procurement of any products made at a Sandoz plant in Kempton Park, Gauteng, after identifying 41 “non-compliances and deviations” from the organisation’s rules on good manufacturing practice.
The WHO, which operates a pre-qualification programme of quality approval on drugs used by developing countries, found after an inspection in May that sufficient measures were not in place to prevent contamination or to ensure easy cleaning of surfaces in the Sandoz plants, the FT said. The factory produces combinations of rifampicin, an antibiotic used to treat tuberculosis in developing countries.
After the WHO inspectors identified the problems, they proposed a follow-up audit in August to ensure that remedial actions had been taken. However Sandoz reportedly told the agency they would not be able to visit again this year and as a result, the WHO may suspend the plant’s products from its list of prequalified medicines.
However, Sandoz told the newspaper that it is willing to find “an earlier date that is suitable for the inspection team, even if some of the corrective actions will not be complete at that time”. The company said that the WHO concerns “focus mainly on ongoing maintenance issues and controls of existing policies and procedures” and it is committed to completing these changes by the first quarter of 2009, “partly to accommodate the longer-term actions recommended by the WHO”.
The concerns emerged just after the US Food and Drug Administration banned the import into the USA of more than 30 drugs made by Ranbaxy in two of its factories in India, highlighting poor compliance with manufacturing standards.
