Quality is a universal principle, and this volume delivers essential tools for maintaining the Lifecycle of the Quality Management System, as defined by ICHQ10. Targeted for pharmaceutical companies, it introduces the critical framework, The Lifecycle of the Quality Management System.
This volume includes the highly sought after controlled documents for:
-Batch Record Review
-Batch Disposition
-Process and Production Controls
-Product and Process Lifecycle
-Process & Method Development
-Laboratory Controls
-Specification Management
-Labeling Control
-Facilities and Engineering Management
-Stability
-Qualification and Validation Programs
-BPDR
When executed in compliance with regulations and internal standards, these programs ensure a product is maintained throughout the lifecycle as governed by the QMS.
Whether in pharmaceuticals or beyond, this volume offers a structured, actionable approach to achieving quality excellence across industries.