主批次记录（MBR） 是指定义制造方法、材料和其他与产品制造和测试有关的程序、准则和控制的文件，也称为制造模板。MBR 是 GMP（良好生产规范）不可分割的一部分。
主批次记录旨在确保添加了所有适当的成分，并完成和记录了流程中的每个步骤。
主批次记录 MBR（又称主生产记录 MPR 或主制造配方 MMF）是详细的生产指令。 每个独特的配方和批量大小都必须有自己的 MBR.
例如，主批次记录需要以下信息：
- 产品名称标识。
- 一份材料清单，详细说明制作批次所需的每种配料的重量、度量或数量。
- 设备清单。
- 组件列表。
- 生产过程每个阶段的理论产量说明。
- 成品的预期产量。
- 生产过程中每个条件的详细说明。
- 取样和测试程序。
- 手动操作说明。
- Discrepancy data
每个独特的配方和批量都需要这些记录在案的说明，以确保每次生产过程的标准化和可重复性。由于 MBR 是用于复制的原始模板，因此在生产过程中无需填写。它与生产编号或零件编号相关联，但与任何特定批号无关。
Computerised Master Batch Record
A computerised Master Batch Record is a modernised approach to manufacturing record-keeping, integrating advanced software solutions into the production process. This digital transformation revolutionises how manufacturing operations are managed, providing a comprehensive system for creating, managing, and optimising production workflows.
Key Features and Benefits
- Real-time Data Integration: Digital MBR seamlessly integrates with various manufacturing systems, enabling real-time data exchange. This connectivity ensures that up-to-date information is readily available to manufacturing personnel, enhancing decision-making and issue resolution.
- Error Reduction: Automation within Digital MBR significantly reduces the risk of human error by automating data entry and incorporating validation checks. This results in greater consistency and higher product quality.
- Efficient Recipe Management: Digital MBR simplifies the management of multiple recipes for different products and batch sizes. Manufacturers can create, update, and maintain recipes effortlessly, ensuring accurate production every time.
- Version Control: Robust version control capabilities in DMBR systems guarantee that manufacturing instructions comply with the latest regulations. Manufacturers can adapt swiftly to changing requirements without compromising compliance.
- Electronic Signatures and Audit Trails: Computerised MBR facilitates electronic signatures and maintains comprehensive audit trails. This feature is vital for tracking and authenticating critical actions, aiding regulatory compliance, and supporting investigations.
