New FDA standards for manufacturing: USA

The Food and Drug Administration’s (FDA) new Current Good Manufacturing Practices (cGMP) regulatory standards went into into effect on 25 June 2009 for manufacturers with more than 20 employees.

Manufacturers with less than 20 employees have until June 2010.

The new cGMP regulations are significantly different from the old standards.

They will see nutritional supplement manufacturers implementing new testing, documentation, standard operating procedures and formal training policies.

Australian and New Zealand raw material suppliers will need to be prepared for increased testing requirement and trace documentation.

The new standards are forcing companies to be more accountable, to reassess their strengths and weaknesses and should improve the reputation of the dietary supplement industry.

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