Suite of deliverables to support the forecast and demand planning process and complement the FDP Toolkit. They include an optimal process, RACI and template. These areas are where there is potential for the greatest benefit and will create value for industry when used correctly.
Forecast and Demand Planning
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BioPhorum response to USP <1083> draft monograph: Supplier qualification and guidance for associated risk assessments
BioPhorum member only content. This is detailed consultation response from BioPhorum Supply Partner to USP on draft monograph <1083>.
A standard process map providing industry with a set of simple tools containing a structured approach for materials introduction across the supply chain. This paper summarizes a stepwise process that can be used as a guideline for introducing a material to support new drug substance manufacture and can be used in conjunction with detailed, company-specific NPI procedures. In addition it is relevant best practice for cell and gene therapy manufacturers.
The checklist is a best practice checklist to define the recommended minimum required steps to generate a useful forecast. It is for companies moving towards mature demand forecasting practices, and biomanufacturers and suppliers with regular demand forecasting meetings. It should be used each time a new forecast is generated to ensure the key steps are carried out. The communications pack explains the recommended forecast and demand planning cycle of events, i.e. when you should sit down and talk, what you should talk about, what should be in the discussions, etc. This will help guide and structure the regular meetings between biomanufacturers and critical suppliers. Having a comprehensive framework for those meetings is essential, especially when discussing key materials. It includes everything from the minimum required agenda items and an action log template, to a forecast confidence ‘traffic light’ indicator and ‘hints and tips’ to get the most out of the pack.