Content By ISPE

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(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE), a leading authority on best practices for the pharmaceutical industry,  has issued updated and expanded guidance to help pharmaceutical companies maximize testing efficiency of computerized and software-based systems that affect patient safety, product quality, and data integrity.

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(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE) has released its new guidance relating to the design, construction, and commissioning and qualification of packaging, labeling, and warehousing (PACLAW) facilities. The guide helps companies meet current good manufacturing practices (CGMP) requirements for these types of facilities while avoiding product adulteration, product mix-up, label mix-up, and misbranding. The guide contains input from the U.S.

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(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE) just concluded its two-day current good manufacturing practices (CGMP) conference, which was co-sponsored by the U.S. Food and Drug Administration (FDA).

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(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE) has released the latest volume in the Product Quality Lifecycle Implementation (PQLI) series, Change Management System as a Key Element of a Pharmaceutical Quality System. The guide, which is part three of the PQLI series, provides practical, real-world strategies that companies can use to implement the change management recommendations of ICH Q10.

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(ISPE: Tampa, FL) – The International Society for Pharmaceutical Engineering (ISPE) continued its mission to provide a neutral ground for pharmaceutical industry professionals and regulators to discuss industry issues at ISPE affiliate meetings in Japan and China last month.

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(ISPE: Tampa, FL) — The International Society for Pharmaceutical Engineering (ISPE), which provides an educational forum for the pharmaceutical industry, has brought together a substantial lineup of global regulatory officials and pharmaceutical industry leaders to be plenary speakers at the Food and Drug Administration (FDA)/ISPE co-sponsored “Redefining the ‘C’ in ‘CGMP’” conference in Baltimore on June 4–5, 2012.

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(ISPE: Tampa, FL) -- The Food and Drug Administration (FDA) has joined with the International Society for Pharmaceutical Engineering (ISPE) to deliver an integrated learning conference focused on industry and regulatory viewpoints concerning current good manufacturing practices (CGMP). The conference, “Redefining the ‘C’ in CGMP—Creating, Implementing, and Sustaining a Culture of Compliance,” will be held in Baltimore, June 4–5, 2012. It is the first joint ISPE-FDA conference focused on CGMP issues.

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(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE), a society for professionals involved in the engineering and manufacture of pharmaceuticals and related products, has issued industry guidance to advise clinical trials on comparator management activities. The ISPE Good Practice Guide: Comparator Management is the pharmaceutical industry’s first-ever resource for comparator processes such as product sourcing and blinding. It identifies good practices for making sourcing decisions, including how to set up a good sourcing team.

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(ISPE: Tampa, FL) – The International Society for Pharmaceutical Engineering (ISPE) has released a new industry guidance document, Project Management for the Pharmaceutical Industry. This guide is the first document of its type to discuss and compile best practices for project management concepts within the context of the pharmaceutical industry. The guide serves as a toolkit to help pharmaceutical project managers deliver successful projects quickly.

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(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE), a global nonprofit association of 22,000 pharmaceutical science and manufacturing professionals, has released a new guidance document on pharmaceutical commissioning and qualification titled, ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification. This new guide successfully provides a bridge between the baseline strategies outlined in the [Read More]