About Careers MedBlog Contact us
Medindia LOGIN REGISTER
Advertisement

Beware of Drugs from Sandoz South Africa Plant: WHO

by Rajashri on September 23, 2008 at 1:41 PM
Font : A-A+

 Beware of Drugs from Sandoz South Africa Plant: WHO

Drugs made by Swiss pharma giant Novartis's Sandoz generics unit in South Africa may be contaminated, the World Health Organization has warned after an inspection of the facility revealed more than 40 faults.

The WHO said it had sent an official "Notice of Concern" letter to Sandoz on September 12 after an inspection of the unit's Kempton Park factory in South Africa.

Advertisement

That had revealed 41 separate cases classified as "non-compliances and deviations from the WHO Good Manufacturing Practices."

For example, "the company failed to ensure that where starting and primary packaging materials and intermediate or bulk products were exposed to the environment, interior surfaces were not smooth and free from cracks and open joints, and did not permit easy and effective cleaning and, if necessary, disinfection," the WHO said in its letter.
Advertisement

The inspection was carried out in May, said the WHO.

Since then however, Sandoz had failed to take sufficient steps to remedy the situation and thus the WHO has deemed the Kempton Park site to be "operating not in compliance with WHO GMP."

As such, the WHO would "recommend suspension of procurement of all prequalified products manufactured at this site, (and) withhold prequalification of all new products," the letter said.

These recommendations would remain in force "until satisfactory corrective actions have been implemented by the manufacturer and verified by WHO," it added.

Source: AFP
RAS/SK
Advertisement

Advertisement
Advertisement

Recommended Reading

Latest General Health News

What Are the Consequences of Celebrities Endorsing Tobacco?
In India, youth must be aware of the diseases linked to cigarette smoking and tobacco consumption, causing a form of healthcare emergency.
 People Living Close to the Seaside Enjoy Better Health
Direct coastal access may represent a viable route to public health promotion, but the relationships of coastal living are not strongest among lower-income groups.
 Over Four Million Gardeners Place Their Hearing in Danger
New research by Tinnitus UK has found that over four million gardeners are putting their hearing capacity at risk this summer without using safety protection.
Breaking the Barrier: Unraveling Mucus Plugs to Save Lives in COPD
Mucus plugs could be targeted to help reduce fatalities from chronic obstructive pulmonary disease.
 Disease Modifying Therapies for Multiple Sclerosis Continue to Drive Up Healthcare Cost
The development of reliable curative therapies for multiple sclerosis could significantly reduce the economic burden of the disease on patients and wider society.
View All
This site uses cookies to deliver our services.By using our site, you acknowledge that you have read and understand our Cookie Policy, Privacy Policy, and our Terms of Use  Ok, Got it. Close
×

Beware of Drugs from Sandoz South Africa Plant: WHO Personalised Printable Document (PDF)

Please complete this form and we'll send you a personalised information that is requested

You may use this for your own reference or forward it to your friends.

Please use the information prudently. If you are not a medical doctor please remember to consult your healthcare provider as this information is not a substitute for professional advice.

Name *

Email Address *

Country *

Areas of Interests