📘 SOP for Batch Manufacturing Record (BMR) Preparation, Execution & Review
📘 SOP for Batch Manufacturing Record (BMR) Preparation, Execution & Review 1. Introduction Batch Manufacturing Records (BMRs) are controlled GMP documents that define and capture all manufacturing activities for a specific batch. Accurate preparation, execution, and review of BMRs ensure traceability, data integrity, product quality, and compliance with regulatory requirements. 2. Purpose To establish a detailed and standardized procedure for preparation, issuance, execution, review, reconciliation, and approval of Batch Manufacturing Records to ensure compliance with GMP, data integrity principles, and regulatory expectations. 3. Scope This SOP is applicable to all pharmaceutical products manufactured at the site and covers all departments involved in BMR preparation, execution, review, and approval including Production, Quality Assurance (QA), Quality Control (QC), Warehouse, and Documentation. 4. Responsibilities Prod...