These tools support sharing the optimal high-level steps to simplify a process and invite people into the discussion using a common language. The optimal process outlines the essential process steps and for each one lists the ‘who’ (i.e., which role) and the ‘how’ (i.e., what medium). The RACI supports people to understand where accountabilities and responsibilities lie.
Viewing related articles
Accelerating multi-product biopharmaceutical manufacturing facility project lifecycle through modular design
This paper uses a standardized, modular design and construction approach the benefits of a modular design approach to a multi-product viral vector (VV) facility at late-clinical/early-commercial scale, showing how significant speed benefits can be gained at each stage of facility design, procurement, construction, qualification and operation.
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.
The topic of campaign manufacture for lyophilization processes was discussed by the BioPhorum Lyophilization group. This member only publication is a summary of the approach taken by the major biopharmaceutical companies with experience of campaign manufacture who are members of the group.
A BioPhorum member only tool providing a useful collection of standards, reporting mechanisms and standards bodies within the sustainability arena
This document describes the basis for performing a risk assessment for line clearance (LC) activities and failures. It contains a general description about the process and a template. This template is meant to support the documentation of the assessment of risks related to the LC process in secondary packaging lines handling pharmaceutical products and combination devices.
The purpose of this BioPhorum member only survey is to assess the use and control strategy for ready to use (RtU) cells used in bioassays.
This benchmarking survey from the BioPhorum Forced Degradation team has conduced a benchmarking survey for formal comparability assessments.
This member only survey covers the challenges of working with ultra-high concentration formulations, including; low dose volume products, viscosity aspects related to manufacturing and delivery, manufacturing and filling, automated screening, analytical challenges, osmolality considerations (hyper and hypo), syringeability, acceptable injection forces.
Data integrity is fundamental to comply with current good manufacturing practices (CGMP) and ensure patient safety. Unsurprisingly, quality control (QC) lab data are heavily scrutinized during audits as they directly support the quality, safety and efficacy of the product, and indicate the state of control of a facility. Most QC labs have worked hard to establish the fundamentals of data integrity. Many have digitized to eliminate paper, some systems have compliance features built in, and a series of mitigations and workarounds cover the rest, albeit with some inefficiencies and limitations. There have also been significant evolution of systems and business practices, rising expectations for efficient and thorough investigation capability, and the desire to go beyond compliance and get knowledge and insights through better access to data. Next steps in data integrity are key to the QC lab of the future and the digital maturity of the manufacturing capability as a whole.