Overview:

In recent years, Manufacturing Execution Systems (MES) and Process Control Systems (PCS) have gained wide acceptance in the pharmaceutical and biotech industries, due to the adoption of industry standards and technology advancements. PCS for bulk therapeutic and biotherapeutic manufacturing achieved uniformity in the past decade thanks to the establishment of the ANSI/ISA-99 models for batch control. During the same period, a broader range of industries used MES and ANSI/ISA-95 standards to improve their manufacturing operations.