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Good Manufacturing Practice in pharmaceutical

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Guest user Created:   Oct 13, 2022 Last commented:   Oct 13, 2022

Good Manufacturing Practice in pharmaceutical

We are looking for guidance with regards to Good Manufacturing Practice. Is this a certification that pharmaceutical companies need to apply for? How do they apply? If the company has ISO13485, can they use the GMP mark? or do they need to be registered for GMP?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Oct 13, 2022

Yes, there is a certificate for GMP which can be provided both by the notify body or by a competent authority in a particular country (usually the Ministry of health, but you need to check how is in your country that organized). 
A company that has ISO 13485 can not use the GMP mark without approval from notify body or competent authority.  

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Oct 13, 2022

Oct 13, 2022