Videos
This third edition of the ISPE Baseline® Guide: Biopharmaceutical Manufacturing Facilities intends to further reinforce the concepts described in the second edition of the Guide, provide examples of how these concepts can be...
Introducing the Future of ISPE Guidance Documents At ISPE, our mission has always been to connect knowledge, operational excellence and regulatory insights. In keeping with this commitment, we are excited to announce that we...
Maintaining the principles and framework of the first edition published in 2008, the much-anticipated ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition): Provides updates to...
Maintaining the principles and framework of the first edition published in 2008, the much-anticipated ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition): Provides updates to...
Maintaining the principles and framework of the first edition published in 2008, the much-anticipated ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition): Provides updates to...
ISPE has been in the forefront of the quality metrics dialog by hosting FDA and industry forums and workshops, conducting the industry’s first Quality Metrics Pilot Program, and providing input to the FDA draft Guidances...
Maintenance can impact both the quality of products and the compliance of pharmaceutical processes. Maintenance programs have long been recognized as critical to the success of the operations they support. The ISPE Good...
In 2008, ICH Q10 identified Knowledge Management (KM) and Quality Risk Management (QRM) as the enablers of an effective Pharmaceutical Quality System (PQS). Since then, the pharmaceutical industry has been slow in...
Why is commissioning & qualification important? Is qualification the same as verification? What is a key factor when implementing a risk management approach to commissioning and qualification? What is a common misconception...
Regulatory agencies expect the development and validation of a compliant cleaning program. This critical activity ensures that the risks of contamination, product carry over, and cross-contamination is controlled, minimized...
Regulatory compliance of critical utilities is essential to maintaining overall facility compliance. Due to their hidden nature, critical utilities can become vulnerable to non-compliance and significantly increase the risk...
The design, construction, commissioning, qualification, and continued performance of water and steam systems for the pharmaceutical industry present significant challenges. These systems need to meet Good Manufacturing...
Transfer 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...
A Road Map to Implement Single-Use Technology Single-use technology (SUT) has grown in both complexity of design and criticality of application in the past twenty years, offering increased flexibility while significantly...
Hear from two of the guide contributors, Gordon Leichter, PhD, Belimed Life Sciences and Jason Collins, AIA, IPS, on what you will take-away from purchasing this guide including practical and regulatory guidance...