An ISPE presentation defines Batch Disposition as the:
…documented control, status and/or usage for a Product. Examples include, without limitation, release, rejection, quarantine, hold, release for packaging, returns, destruction.
In a recently released BioPhorum paper, BATCH DISPOSITION: A shared vision and practical framework for digitized transformation, Emerson’s Michalle Adkins and Debbie Bouwens joined with other experts in the Life Sciences industry to author this work.
Their executive summary opens with a statement of purpose.
This manifesto sets out a shared vision to transform batch disposition across the biopharmaceutical industry. As the final decision-making step in pharmaceutical manufacturing, batch disposition ensures each batch is reviewed and approved for product release based on confirmation that it has been manufactured, tested, stored and handled in accordance with quality, safety and compliance requirements. This release includes supporting data, validating product integrity and alignment with regulatory expectations.
The six major sections of this paper include:
- Introduction
- Key principles to advancing digital maturity
- Industry standards and mandates from regulators
- The end goal
- Call to action
- Conclusion
The introduction explores hindrances to effective batch disposition and the benefits of successful transformations.
Batch disposition is a pivotal control point in pharmaceutical manufacturing, yet it remains one of the most under-digitized and inconsistent processes across the industry. As innovation accelerates and supply chains grow more complex, the limitations of traditional batch disposition practices are becoming increasingly evident. These inefficiencies not only hinder compliance and operational performance but also delay patient access to critical medicines and therapies.
The vision of the paper’s authors is:
…to transform batch disposition from a fragmented, manual process into a strategic, digitally enabled capability, one that supports faster, more reliable release decisions across the biopharmaceutical lifecycle. This transformation is not linear or uniform; it requires organizations to assess their current maturity, identify meaningful opportunities and implement adaptable principles that fit their unique context.
By aligning around a common framework and embracing incremental progress, the industry can collectively advance toward a more harmonized, intelligent and patient-focused future. To move from vision to action, organizations need a practical approach that supports both strategic alignment and operational flexibility. This paper outlines foundational concepts and enabling principles to guide progress through the maturity model toward a more digitized, efficient and compliant batch disposition process.
Download the paper for more on the key principles and considerations for applying the framework to drive more efficient, agile biopharmaceutical manufacturing operations.
