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General recommendations for harmonization of local regulations for post-approval submissions with WHO and ICH guidelines, example of Brazil

General recommendations for harmonization of local regulations for post-approval submissions with WHO and ICH guidelines, example of Brazil

This concept paper outlines BioPhorum’s considerations regarding Anvisa’s intention to adopt WHO guidelines while meeting the related ICH ones. The paper demonstrates how national regulatory agencies and biomanufacturers can make use of both guidelines and introduces the desired principles for national regulations.

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Lyophyilization: commercial scaling modelling

Lyophyilization: commercial scaling modelling

This paper outlines different applications of modeling to freeze-drying of biopharmaceutical products at commercial scale. It also signals the intent of the BioPhorum collaboration to champion a wider adoption, and realize the full potential of modeling across the industry to standardize lyophilization practices, accelerate technology transfers and optimize operational performance. An Industry Perspective on the Application of Modelling to...

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How does your digital plant maturity compare?

How does your digital plant maturity compare?

The Digital Plant Maturity Model workstream has developed a new version of the Maturity Model. This second version increases consistency by leveling scores across dimensions; simplifies the model by reducing the number of enabling dimensions; and improves its utility by resetting the vision for levels 4 and 5, aligning them with the BioPhorum Technology Roadmap. The team has also developed a Maturity Assessment Tool to be used alongside the...

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Maintenance Frequency Optimization Tools And Processes

Maintenance Frequency Optimization Tools And Processes

The BPOG DS reliability workstream has developed guidance enabling member companies to optimize their maintenance and calibration frequencies by assigning the correct ‘trigger’ for these activities.  The guidance describes the various tools and processes available, as well as methods to implement change, illustrated by case studies. The Return on Investment (RoI) for optimization of maintenance frequencies is clear – direct reduction of...

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