Recipe Development Process Re-Design with ANSI/ISA-88 Batch Control Standard in the Pharmaceutical Industry:

International Journal of Engineering Business Management

MargheritaDe Minicis¹ 

关键词: ANSI/ISA-88 St;    ard;    Recipe Development Process;    Business Process Management;    Process Mapping;   

DOI  :  10.5772/59025

学科分类：工程和技术（综合）

来源: Sage Journals

【 摘 要 】

Reducing time-to-market is one of the most challenging tasks that pharmaceutical companies deal with. In this sense, the recipe development process represents one of the most critical phases. Multi-site production companies require an efficient recipe development model, with a robust modular structure, which must be appropriately shared among local laboratories and plants. To this extent, the ANSI/ISA-88 batch manufacturing standard, rising in the context of process control and automation, is rapidly becoming widely used in pharmaceutical companies. This paper presents a step-by-step approach to assessing the compliance to the ANSI/ISA-88 standard along with a BPM-oriented methodology applicable to the re-design of any generic recipe development process. Redesigning a recipe development process is a complex activity and can mask several pitfalls and criticalities. Thus, along with the methodology, some general evidence and suggestions are provided based on the experience of a project carried out in a large multinational pharmaceutical company.

【 授权许可】

CC BY