27 July, 2021
News & Press Releases
ISPE has been honored as the winner of a 2021 APEX Award for Publication Excellence in the COVID-19 Media Government/Association content category for the four-article Special...
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Global News
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|26 July, 2021iSpeak BlogVaccine Manufacturing Innovation Awareness of the pharmaceutical industry has increased significantly in the last 15 months due to the global pandemic. Vaccine manufacturing...
|22 July, 2021iSpeak BlogThe past year has been unprecedented for the manner in which the world’s population has adapted to living with the changes brought about by COVID. The life sciences sector has... -
Chapter Events
|17 August, 2021
Vendor Night Outdoors at The Park in the Eureka Building
27th ANNUAL VENDOR NIGHT EXHIBIT SHOW EUREKA BUILDING IRVINE About the venue: In 2013, our Founder had his Eureka Moment: to offer Orange County’s entrepreneurs a centrally...
|16 August, 2021Greater Los Angeles Area Chapter - Golf Tournament at Strawberry Farms Golf Club in Irvine
Golf Tournament at Strawberry Farms Golf Club in Irvine PLEASE NOTE: There is a change to the available sponsorship options worthy of a note here: NEW INFORMATION FOR THE... -
Videos
|VideoISPE Expert Xchange is a new interactive, collaborative experience that unites forward-thinking pharma professionals with engaged subject matter experts for immersive, topic-focused events. Benefit from years of...
|VideoJoin us on 6 May 2021 for the FREE live webinar "503B Compounding Pharmacies: Principles, GMPs, and Case Studies" to take an in-depth look at how this field has developed since section 503B was created as part of the...
|VideoTechnology and innovation in the pharmaceutical industry are more critical now than ever before as healthcare worldwide is straining from the COVID-19 pandemic. Even in these trying times, it is important to spotlight...
Guidance Documents
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APQ Guide: Management Responsibilities & Review (MRR)
APQ Guide: Management Responsibilities & Review (MRR)
PublishedICH Q10 sets a clear expectation regarding the role of strong leadership in terms of demonstrating and communicating “strong and visible support for the pharmaceutical quality system.” The ISPE APQ Guide: Management Responsibilities and Management Review provides a quality management framework for assessing and advancing leadership systems. It provides a systematic and proactive approach to evaluating management responsibilities highlighted in ICH Q10 as well as other key leadership components: -
Good Practice Guide: Knowledge Management in the Pharmaceutical Industry
Good Practice Guide: Knowledge Management in the Pharmaceutical Industry
PublishedICH Q10 outlines three objectives: achieve product realization, establish and maintain a state of control, and facilitate continual improvement. Embracing these objectives can be best achieved using the dual enablers, Knowledge Management (KM) and Quality Risk Management (QRM). -
Good Practice Guide: Maintenance 2nd Edition
Good Practice Guide: Maintenance 2nd Edition
PublishedMaintenance 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. -
Good Practice Guide: Equipment Reliability
Good Practice Guide: Equipment Reliability
PublishedEquipment reliability is concerned with the risk of failures in equipment and processes, providing focus on equipment availability, fitness for purpose, and cost. The strategy and tactics of reliability contribute to realizing the value of equipment throughout its useful life and mission.
Continuous manufacturing has attracted significant interest over the past decade for small molecules formulated as drug products. The case for adopting continuous manufacturing platforms for manufacturing biologics (i.e., large proteins or biologic products such as...
