Sandoz, the generics arm of Swiss drug giant Novartis, was being inspected by the World Health Organisation (WHO) under its prequalification programme, which is designed to ensure the quality of medicines that are widely used in developing countries.
Some of the good manufacturing practice (GMP) deviations identified at the facility, which mainly produces rifampicin for the treatment of tuberculosis, include a failure “to exercise sufficient control of the HVAC system,” and that some of the interior surfaces of manufacturing lines “did not permit easy and effective cleaning”.
According to a September 21 report in the Financial Times, Sandoz risks losing WHO support to sell drugs made at the plant after the firm said that it would not be able to accommodate a proposed follow-up inspection until 2009
In response, Sandoz said that: “The WHO NoC involves a limited number of tuberculosis products produced in South Africa that are pre-qualified by the WHO.
“The WHO concerns focus mainly on ongoing maintenance issues and controls of existing policies and procedures of those issues identified by the WHO, none were classified as critical, only one as major and the rest as other,” it continued.
Sandoz also stressed that: “The WHO has voiced no concerns involving the quality, safety or efficacy of end products. Sandoz had committed to completing these changes by Q1 2009, partly to accommodate the longer term actions recommended by the WHO.
The company added that after further discussions with the WHO it “will now find an earlier date that is suitable for the inspection team, even if some of the corrective actions [that it has instigated] will not be complete at that time”.
Further GMP failure
The news is a further blow for Sandoz on the GMP front following the US Food and Drug Administration’s report of “significant deviations” at the firm’s Wilson, North Carolina plant earlier this year.
In that case, the FDA said that Sandoz had failed to validate processes used in the production of metoprolol succinate ER tablets, and had used “unrelated batches of the drug to validate required content uniformity and dissolution tests.”
At the time, Sandoz communications officer Chris Lewis told in-PharmaTechnologist that the firm has: “initiated corrective actions including a comprehensive quality improvement plan for the Wilson plant and is currently reviewing all related documentation and practices.