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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. The second edition of the GAMP testing guide for GxP systems has been revised to conform with GAMP 5 concepts and terminology and reflect ICH Q8, Q9, and Q10, quality by design, and process analytical technology principles. It has also been expanded to include information on cloud computing, automated testing, and nonlinear development.

“We have aimed this guide at anyone who has ever worried that their testing is not sufficiently focused on the real risks to patient safety or wondered whether they might be doing too much or too little testing,” says Karen Ashworth, who co-led the industry group responsible for producing the guidance. “The guide offers practical advice on how to use risk assessment to define the correct scope of testing and on how to avoid costly duplication of testing that has already been done by a supplier or at an earlier phase of the system life cycle.”

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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. Food and Drug Administration (FDA) and is the industry’s only guidance of this type for PACLAW facilities.

“PACLAW facilities are very different from other types of pharmaceutical facilities, and up until this point, there has been no consistent guidance available to help companies ensure compliance,” says guide author Nick Davies. “With this ISPE Good Practice Guide, the industry finally has tools to ensure their PACLAW processes are efficient, compare their processes to established best practices, and demonstrate compliance to regulatory agencies.”

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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). Held June 4–5, 2012, in Baltimore, the conference met with resounding support from more than 300 participants, who discussed how to more aggressively advance ISPE’s role in facilitating discussions among industry and regulators on issues that strengthen the safety of pharmaceutical products and devices produced around the world.

This conference focused on the importance of driving a culture of quality throughout companies and regulatory agencies. It addressed how quality management systems and risk management tools are being applied to mitigate risks that could occur as the industry faces pressures to reduce costs and manage complexities in global supply chains.

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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. It is the only change management guide written expressly for the pharmaceutical industry.

“Good change management is an important part of any business, but for the pharmaceutical industry, there are special considerations that must be kept in mind,” says guide author Rob Hughes. “Whether a company needs help translating the holistic approach described in Q10 into an actionable plan or simply wants to update and improve its change management practices, this guide provides the tools they need to reach their goal.”

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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. The events brought together officials from the Food and Drug Administration (FDA), the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (PIC/S), the Pharmaceuticals and Medical Devices Agency (PMDA), the Medicines and Healthcare Regulatory Agency (MHRA), China’s State Food and Drug Administration (SFDA), and other agencies to discuss top industry concerns for pharmaceutical professionals and groups, such as the International Leadership Forum (ILF).

“As the independent pharmaceutical manufacturing association, ISPE is dedicated to strengthening the industry through meetings like the ones just concluded in Japan and China,” says ISPE’s president and CEO Nancy Berg. “These meetings were enormously successful in providing a forum for regulators and industry from two of the top pharmaceutical world markets to engage in face-to-face dialogue around real-world problems and solutions.”

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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. These top regulatory and industry professionals will speak on the key current good manufacturing practice (CGMP) issues affecting the pharmaceutical industry today.

“This first annual collaborative FDA-ISPE event is on track to become a landmark conference with unprecedented opportunities for regulators and industry professionals to engage in dialogue, solve problems, and learn from one another,” says ISPE’s president and CEO, Nancy Berg. “It’s not often that a single conference is able to present this many relevant, high-level speakers. The caliber of these speakers illustrates ISPE’s and FDA’s shared commitment to addressing quality and manufacturing challenges to ensure the safety and availability of the world’s drug supply.”

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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.

The conference will feature a new format with a number of audience-participation and interactive sessions. Attendees engage in discussion with regulators on critical industry issues, concerns, and collaboration during the Hot Topic Discussion Forum. A mixed panel of FDA and industry leaders will answer the industry’s most pressing questions during a moderated “Meet the Press” session. Topical plenary and education sessions will be featured throughout the two-day event.

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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. The guide discusses good practices for blinding and releasing a comparator for use. It also explains the risks involved with ineffective comparator methods, and provides companies with strategies for avoiding the costs, delays, and potential case-study inaccuracies that might result from faulty comparator management.

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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. It also offers content that addresses managing risks common to pharmaceutical projects and develops a common language for the pharmaceutical project management community.

“The pharmaceutical industry presents unique regulatory and business aspects to the field of project management,” says Trish Melton, one of the guide’s lead authors. “Increased speed to market for new drugs has meant that most projects are under pressure to deliver faster while maintaining compliance in a shifting regulatory environment, and meeting cost and scope objectives in an increasingly competitive market. This welcomed guide is the industry’s first to offer user-friendly, specific tools and techniques to integrate regulatory compliance with the project life cycle.”

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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 ISPE Baseline Guide, Volume 5: Commissioning and Qualification and the more advanced strategies prescribed in the ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment.