USFDA warns Indian drug makers to comply with GMP standards

By: Pharma News | Views: 1942 | Date: 05-Aug-2013

USFDA states that they find contaminants like filth, pesticides and insect parts in drugs manufactured in many countries including India. FDA aims at ensuring that manufacturing facilities in India that import drugs to the US understand the risks associated with their product's processes and want an assurance that the drug companies will remain compliant to FDA's regulations.

USFDA warns Indian drug makers to comply with GMP standards



USFDA states that they find contaminants like filth, pesticides and insect parts in drugs manufactured in many countries including India. FDA aims at ensuring that manufacturing facilities in India that import drugs to the US understand the risks associated with their product's processes and want an assurance that the drug companies will remain compliant to FDA's regulations.

During FDA inspections in India, problems that were similar to those found around the world were encountered. They included issues associated with quality systems implementation, data integrity, and validation of various processes used in different stages of manufacturing or testing. FDA has also encountered with problems like adulteration with unexpected contaminants like microbiological agents (such as salmonella, listeria) or products identified with unapproved chemicals or pesticides, or presence of filth (such as foreign bodies, insect parts).


While the FDA is confident that many companies understand and comply with Good Manufacturing Practices (GMPs) it is also important to remain vigilant and take appropriate action in case of any non-compliance observed. As per the FDA, information sharing, knowledge of best practices and effective changes in regulations can help drug makers in ensuring better products and supply chains.
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