Francesco Giordano

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

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.

On Just-In-Time Production Leveling

On the other side, it is also well known that not every implementation of Lean Production was a success, especially in Western companies: some enterprises – together with the consultancy firms that should have supported them – forgot that there are some main hypotheses and issues to comply with, in order to achieve Toyota-like results. On top of this, certain requisites are not related to a mere managerial approach, but depend on exogenous conditions, e.g. market behavior or supplier location; thus, not every company can successfully implement a TPS system.