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Global News
19 September, 2019Falsified Medicines Directive – Implementation in Clinical Supply Chains
Falsified Medicines Directive 2011/62/EU was published by the Eur...Falsified Medicines Directive 2011/62/EU was published by the European Parliament on 08-Jun-2011. The Directive was implemented to increase the security of the manufacturing a... View All Blog Posts19 September, 201919 September, 2019ISPE announced the results of its 2019–2020 International Board of...September 19, 2019View All NewsISPE announced the results of its 2019–2020 International Board of Directors election, revealing a slate of strategic leaders who represent a variety of pharmaceutical industry sectors. The Board is responsible...
17 September, 2019Placing Patients at the Center with ‘Direct to Patient’ IMP Delivery
The voice of one patient and a pandemic in South Korea in 2014 pr...The voice of one patient and a pandemic in South Korea in 2014 prompted a new approach to dispensing Investigational Medicine Products (IMP) -- bringing the medicine directly... View All Blog Posts17 September, 2019
16 September, 2019What Is Women in Pharma? What Do They Do? How Do I Get Involved?
Adapting to new situations can be hard – new job, new city, new i...Adapting to new situations can be hard – new job, new city, new industry – change is rarely easy, and adapting to a new idea of ‘self’ can be even more challenging. We ask our... View All Blog Posts16 September, 2019 -
chapter Events
October02
ISPE LA and WIP - Your Next Career Move Small Biotech Vs. Big Pharma
Your Next Career Move Small Biotech Vs. Big Pharma You...Kite Pharma
October 02, 2019View All EventsYour Next Career Move Small Biotech Vs. Big Pharma You Are Invited To A Women in Pharma After Hours Event Celebrating Women, Presented by Women, Open to Men and Women... -
Videos
Global health authorities play a significant role, ensuring the safety and efficacy of approved drugs—for new innovations and already existing products. ISPE takes pride in the strong regulatory presence we bring to all...
James Breen, Jr., PE, 2018–2019 Chair, ISPE International Board of Directors, Vice President, Lead Biologics Expansion, Janssen Pharmaceuticals, shares how at the heart of the ISPE Annual Meeting & Expo is an opportunity...
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...
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
Risk management is pervasive throughout the biopharmaceutical industry. It is an important factor during the implementation of new equipment or procedures into an operation. Likewise, risk management is also key when assessing the impact of...
