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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 redesign 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.

According to many authors the role of maintenance management in improving production quality is particularly important. In literature, this issue has been discussed mainly considering the adoption of statistical process control as a way to prevent out-of-control production. However, most methodologies are characterized by the optimization of maintenance cycle costs without considering the consequences that out-of-control processes have on production cycles. On these considerations, the paper presents a monitoring maintenance model in which costs of production losses are considered. Proposed methodology is applied to a case study in a pharmaceutical plant where avoid production losses is particularly important. © 2012 Taylor & Francis Group

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