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Global News
21 August, 2019ISPE announced their 2019 ISPE Europe Pharma 4.0™ Conference ,...August 21, 2019View All NewsISPE announced their 2019 ISPE Europe Pharma 4.0™ Conference , taking place 20–21 November in Manchester, United Kingdom. Pharma 4.0™ is a trending industry initiative that highlights the impact and...
19 August, 2019The “PIC/S GMP Inspection Reliance Initiative”: Benefits for both Industry and Regulatory Authorities
Pharmaceutical manufacturing sites that export their products aro...Pharmaceutical manufacturing sites that export their products around the world are often subjected to many GMP inspections each year by different regulatory authorities, with... View All Blog Posts19 August, 2019
14 August, 2019Meet Moderna, Inc. - 2019 Facility of the Future Category Winner
Moderna, Inc. is the 2019 Facility of the Year Category Winner fo...Moderna, Inc. is the 2019 Facility of the Year Category Winner for Facility of the Future for their New cGMP Clinical Manufacturing Facility in Norwood, MA.... View All Blog Posts14 August, 201914 August, 2019ISPE announced its featured speakers for the 2019 ISPE Annual...August 14, 2019View All NewsISPE announced its featured speakers for the 2019 ISPE Annual Meeting & Expo . Taking place 27–30 October 2019 in Las Vegas, Nevada, this signature event brings together top pharmaceutical... -
chapter Events
September18
Cell & Gene Therapy The Evolution of Immunotherapy - From Development to Utilization by Dendreon Lessons Learned Yescarta by Kite Pharma
Cell & Gene Therapy The Evolution of Immunotherapy From Development...Dendreon
September 18, 2019View All EventsCell & Gene Therapy The Evolution of Immunotherapy From Development to Utilization by Dendreon Lessons Learned Yescarta by Kite Pharma DETAILS About the Speakers Bruce Johnson, Site Director, Dendreon An...August2321st Annual Golf Tournament
NEW THIS YEAR: Golf 101 Clinic Maybe you’ve wanted to...Strawberry Farms Golf Club
August 23, 2019View All EventsNEW THIS YEAR: Golf 101 Clinic Maybe you’ve wanted to be a part of the golf tournament but felt your game wasn’t up to par (wink!). Or, maybe you’ve always...August21Los Angeles Dodgers vs Toronto Blue Jays Social
Announces A Summer Social Los Angeles Dodgers vs Toronto Blue...Dodger Stadiuim
August 21, 2019View All EventsAnnounces A Summer Social Los Angeles Dodgers vs Toronto Blue Jays Wednesday, August 21, 2019 Join other ISPE Members for a fun social event watching the number one team this...August21Pharmaceutical Engineering Internship Program Part Two – Lessons Learned
PHARMACEUTICAL ENGINEERING INTERNSHIP PROGRAM PART 2 Followed by a Dodger...El Passeo Inn Olvera Street
August 21, 2019View All EventsPHARMACEUTICAL ENGINEERING INTERNSHIP PROGRAM PART 2 Followed by a Dodger Game Social Program Managers: Edward Smith, Manager, Project Management - Facilities & Critical Utilities, B Braun Medical Paul Crissman, Principal,... -
Videos
Carmelo Rosa, PsyD, Director, Division of Drug Quality I, FDA/CDER, program committee chair of the 2019 ISPE South Asia Pharmaceutical Manufacturing Conference, shares key program highlights and benefits you'll gain by...
The 2019 FOYA Banquet is the ideal place to meet industry experts and gain inspiration from the featured state-of-the-art projects. Together with your colleagues, join ISPE in recognizing the achievements of eight...
Think you can skip this year's Annual Meeting? Think again! The ISPE Annual Meeting & Expo brings together global regulators, leading experts, and high-profile thought leaders to get big-picture insights and critical...
Guidance Documents
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Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition
Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition
PublishedThe ISPE Baseline® Guide: Commissioning and Qualification (Second Edition) provides practical guidance on the implementation of a science and risk-based approach for the Commissioning and Qualification (C&Q) of pharmaceutical manufacturing facilities, systems, utilities, and equipment to demonstrate that they are suitable for the intended purpose. -
GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records
GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records
PublishedThe ISPE GAMP® RDI Good Practice Guide: Data Integrity – Manufacturing Records provides practical and pragmatic advice on areas such as regulated records, data flows, and risk management approaches, with particular focus on process control systems, manufacturing execution systems, and the interfaces and relationship between them. -
Good Practice Guide: Process Validation
Good Practice Guide: Process Validation
PublishedThe shift in process validation from a one-time event to the product lifecycle approach expected by most global markets has led to significant changes in validation practices. The science and risk-based approach combines product development knowledge with a structured process performance and product quality monitoring system to provide for validation throughout the product lifecycle. -
Good Practice Guide: Technology Transfer 3rd Edition
Good Practice Guide: Technology Transfer 3rd Edition
PublishedTransfer of manufacturing processes and analytical procedures between facilities or laboratories is a necessary part of pharmaceutical development and commercialization. Technology transfers take the outputs of process or method development activities and transfer the knowledge to a different location where a process or analytical procedure will be operated.
ISPE Blog
Being on the cutting edge of drug development is the goal of most pharmaceutical companies, but a new drug won’t work if the patient doesn’t take it. It’s a vexing problem that developers of healthcare...
