International Journal of Engineering Business Management, 2014
Reducing time-to-market is one of the most challenging tasks that pharmaceutical companies deal w... more 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.
Reducing time-to-market is one of the most
challenging tasks that pharmaceutical companies deal
... more 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
International Journal of Engineering Business Management, 2014
Reducing time-to-market is one of the most challenging tasks that pharmaceutical companies deal w... more 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.
Reducing time-to-market is one of the most
challenging tasks that pharmaceutical companies deal
... more 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
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Papers by Federico Poli
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
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