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EU GMP and FDA GMP Audit

November 29, 2016
by SeerPharma

SeerPharma was asked to conduct a mock GMP audit of a Korean Pharmaceutical company that produces non-sterile solid dosage forms and finished products.

The scope was for SeerPharma to conduct a three-day mock GMP inspection, on behalf of a European regulatory consultancy, to assess the Korean manufacturer's compliance to EU GMPs and FDA GMPs.

“I would like to share with you a very positive feedback from both our client and our project management team on your performance. We are very happy that the audit went well.”

The customer has since requested SeerPharma provide futher compliance support in the future and in other parts of Asia.

Contact us should you require assistance with GMP compliance including preparing for or responding to a GMP inspection from the TGA (PIC/S), FDA, EU or other GMP regulator.

This post comes from ourJuly 2016 Journal.  You may also be interested in these posts:

 

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Filed Under: Audit, FDA GMP, EU GMP