Compliance and performance are the goal of every drug manufacturer. But they don’t just happen. They are achieved when GMP becomes a lifestyle shared by everyone in the organization.
 
 
Appropriate GMP Level Auditing, Action & Assessment

Pharmavize developed the  concept, an appropriate level GMP auditing, actions and assessment tool. The concept is based on various international guidelines as well as on company practices that are accepted by the authorities.

 stages the various GMP levels in drug development. We subscribe to the view that the stringency of GMP should increase as the process of drug development proceeds from early phase development to final, commercial production steps. We believe the GMP level should be consistent with the development stage, providing flexibility for changes along with increasing knowledge of process and drug product. 

 delivers: 

• well defined and appropriate GMP target levels for each production step as well as for each development phase of the drug product 
• a scorecard-based auditing system that permits to assess the actual levels for each production step and development stage 
• a  well thought action plan to bridge the gap between actual and target levels 
• follow up assessment and continuous improvement 

Do you want to learn more about the  approach? Contact us now!


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