Izvorni znanstveni članak
Recipe Development Process Re-Design with ANSI/ISA-88 Batch Control Standard in the Pharmaceutical Industry
Margherita De Minicis
; Operations Management Team srl, Roma, Italy
Francesco Giordano
; Operations Management Team srl, Roma, Italy
Federico Poli
; Operations Management Team srl, Roma, Italy
Massimiliano M. Schiraldi
orcid.org/0000-0002-1995-7836
; University of Rome “Tor Vergata”, Department of Enterprise Engineering, Roma, Italy
Sažetak
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.
Ključne riječi
ANSI/ISA-88 Standard; Recipe Development Process; Business Process Management; Process Mapping
Hrčak ID:
160719
URI
Datum izdavanja:
1.1.2014.
Posjeta: 2.517 *