What document provides step-by-step instructions for the production process in biomanufacturing?

The Batch Record is the document that provides step-by-step instructions for the production process in biomanufacturing. This record is essential for ensuring that every batch of a product is produced consistently and to specified standards. It includes detailed instructions on the materials to be used, the quantities, the processes to be followed, and any specific parameters that need to be monitored during production.

By meticulously documenting the process, the Batch Record serves as a critical tool for quality assurance and regulatory compliance, providing a historical account of how each batch was made. This allows for traceability in case of any discrepancies or quality issues, and ensures that production can be replicated accurately in future batches.

Other documents mentioned, like Standard Operating Procedures (SOPs), outline general practices and processes, while Activity assays generally refer to tests that measure biological activity, and Quality Control Documents focus on the quality standards and testing outcomes, rather than the production steps themselves.