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Global News
|28 May, 2020iSpeak Blog -
chapter Events
|19 June, 2020
Pharmaceutical Engineering Internship Program Part One - Introduction
Complimentary Webinar for ISPE Members and Non-Members Pharmaceutical Engineering Internship Program Part One - Introduction Format GoToWebinar Instructions to join will be... -
Videos
|VideoThe 2020 ISPE Biopharmaceutical Manufacturing Virtual Conference is a two-day, fully interactive digital event that delivers all of the comprehensive learning opportunities from ISPE’s in-person Biomanufacturing...
|VideoThe 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...
|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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Good Practice Guide: HVAC & Process Equipment Air Filters
Good Practice Guide: HVAC & Process Equipment Air Filters
PublishedThe ISPE Good Practice Guide: HVAC and Process Equipment Air Filters aims to be a valuable reference on the selection, application, specification, testing, and operation and maintenance of filters in the pharmaceutical industry. This Guide is intended to be used as supplement to the ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC), providing detailed information into the subject of air filters in HVAC and process equipment applications. -
Good Practice Guide: Asset Management
Good Practice Guide: Asset Management
PublishedThe ISPE Good Practice Guide: Asset Management provides practical guidance for establishing an asset management system that enables organizations to realize increased value from their assets, both physical and non-physical. This Guide identifies best practices in strategic asset management as outlined in the ISO 55000 series of standards. An effective asset management system translates the organization’s objectives into asset-related decisions, plans, and activities using a risk-based approach. This Guide provides recommendations, examples, and resources to help organizations in the development or improvement of their asset management system. -
Baseline Guide Vol 4: Water & Steam Systems 3rd Edition
Baseline Guide Vol 4: Water & Steam Systems 3rd Edition
PublishedThe ISPE Baseline Guide® Water and Steam Systems (Third Edition) aims to assist with the design, construction, operation, and lifecycle management of new and existing water and steam systems. It is intended to help meet Good Manufacturing Practices (GMPs) and comply with regulations and related guidance. -
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.
On 20 November 2019, the ICH Assembly endorsed the Q12 guideline, “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management,” at its biannual meeting in Singapore. This transformational guideline has a wide scope of applicability...
