Pharma/Biotech
October 18, 2012
The International Society for Pharmaceutical Engineering (ISPE), a not-for-profit association serving its members through leading scientific, technical, and regulatory advancement throughout the entire pharmaceutical lifecycle and a publisher of best practices documents for the pharmaceutical industry, last month released the ISPE Good Practice Guide: Quality Laboratory Facilities. It’s touted as the industry’s first guidance document to establish a baseline for the design of pharmaceutical quality laboratories supporting GxP regulated facilities that produce pharmaceutical products. The guide provides a step-by-step process that leads the reader through all phases of producing a quality lab and all the factors that must be considered at each phase.
The guide describes how to apply a risk assessment to a quality laboratory facility and identify issues to be considered. The main aim of the guide is said to be to:
- Help companies save time and money by facilitating effective communication between lab owners, engineers, and builders about the function, operation, and design parameters that must be met in order to ensure that the finished lab is fit for its intended use
- Provide a step-by-step process that guides companies through all phases of producing a quality lab and all the factors that must be considered at each phase
- Help lab owners explain lab requirements and justify budget requirements to senior management
- Assist engineers in helping their clients focus on the type of information that is required to successfully complete a project
“There’s often a disconnect between the laboratory owner, the designer and the builder when a quality lab facility is being planned and built, which can result in costly mistakes in the design process,” said James O’Brien, President, NAMA Industries, Inc., who is one of the Guide’s authors. “This new Guide helps put all three parties on the same page and gives owners a better understanding of all of the different considerations they must keep in mind so they can avoid giving incorrect or incomplete instructions to the engineer.”
At EquipNet, our Equipment Specialists are experts in a variety of industries and have extensive experience working with pharma manufacturers on both the purchasing and selling sides as they open plants, reconfigure or retool plants, or simply look to shut down operations. We can analyze your operations and provide you with an objective perspective, recommendations, and a prospective schedule for change. If you have any questions about any of these areas, including machinery and low-cost equipment procurement services, machinery inspection services, engineering assessment, or engineering project management services, contact EquipNet.
Categorias: Pharma/Biotech , R&D
Tags: ispe lab trends,
