Golden Batch Analysis
Golden batch analysis is a process used in manufacturing to identify the ideal or “golden” batch of a product. Golden Batch Analysis involves the examination of historical manufacturing data of individual stage of manufacturing to identify relationships between Critical Process Parameters (CPP) and Critical Quality Attributes (CQA). By isolating the factors that significantly impact product quality and yield, pharmaceutical companies can define an ideal or “golden” batch – a benchmark for optimal manufacturing conditions.
Attaining a golden batch signifies that the manufacturing processes have been optimized to the extent where all stages, including granulation, compression, and coating, yield the highest quality product, adheres to regulatory compliance, and is produced with the least amount of waste and inefficiency.
