Dear all,
Is ISO QMS mandatory in the PQMS? if so, what are the regulatory refrences ?
Thanks in advance.
Regards.
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Hi Nadia,
ISO certification is not required for the PQMS, as you get your manufacturing licensing from government agencies.
The PQMS is based on ISO9001 operates but operates on a higher level.
You can learn more about the requirements of the PQMS in ICH Q10.