-
Global News
17 January, 2020Women in Pharma®: Goals 2020
Each year many people start off with how they are going to be bet...Each year many people start off with how they are going to be better than the year before and write down unrealistic goals about their professional and personal time next the... View All Blog Posts17 January, 202016 January, 2020ISPE announced its 2020 ISPE Aseptic Conference, taking place 2–3...January 16, 2020View All NewsISPE announced its 2020 ISPE Aseptic Conference, taking place 2–3 March 2020 in North Bethesda, Maryland. Now in its 29th year, this signature event has established itself as the pharmaceutical...
14 January, 2020Read, Learn, Innovate: Top Blog Posts from Decemeber 2019
Featured in this edition of iSpeak Reading Roundup, are the top b...Featured in this edition of iSpeak Reading Roundup, are the top blog posts from December 2019. Discover key insights for cleaning validation practices, risk-based approaches t... View All Blog Posts14 January, 2020
09 January, 2020Podcast: Water for Injection Using Non-Distillative Methods Webinar Q&A
Since April 2017, the European Pharmacopeia allows to produce Wat...Since April 2017, the European Pharmacopeia allows to produce Water for Injection (WFI) using other methods than distillation. Meanwhile, the additional water quality "Highly... View All Blog Posts09 January, 2020 -
Global Events
January30
2020 ISPE Facilities of the Future Conference
2020 ISPE Facilities of the Future Conference The 2020 ISPE...Grand Hyatt San Francisco
January 30, 2020View All Events2020 ISPE Facilities of the Future Conference The 2020 ISPE Facilities of the Future Conference will explore advancements in pharmaceutical technology and what pharmaceutical manufacturing facilities will look like in...March022020 ISPE Aseptic Conference
2020 ISPE Aseptic Conference Evolution in Aseptic Processing: Flexible and...Bethesda North Marriott Hotel & Conference Center
March 02, 2020View All Events2020 ISPE Aseptic Conference Evolution in Aseptic Processing: Flexible and Reliable Solutions The 2020 ISPE Aseptic Conference will focus on providing flexible and reliable solutions for the implementation and management...January28CleaningValidationCleaning Validation Principles Training Course
This course covers the risk-based approach to cleaning development and...January 28, 2020View All CoursesThis course covers the risk-based approach to cleaning development and verification; risk analysis; procedures and evaluation tools including FMEA / FMECA, master planning, risk control, PAT, periodic assessment and monitoring, risk review and communication.January28FacilitiesProject ManagementPharma Facilities Project Management Training Course
Facility Project Management in the Regulated Pharmaceutical Industry (T26) Overview...January 28, 2020View All CoursesFacility Project Management in the Regulated Pharmaceutical Industry (T26) Overview This classroom course aims to deliver more than the usual project basics and will develop the concept of the project... -
Videos
Regulators from around the globe gathered at the 2019 ISPE Annual Meeting & Expo to discuss advancements and opportunities in Recognition and take questions from the attendees. Learn More
ISPE's Facility of the Year Awards is an annual program that recognizes state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, to reduce the cost of producing high-quality...
Register today for the 2019 ISPE Annual Meeting & Expo, taking place in Las Vegas, Nevada on 27 – 30 October 2019. Learn More & Register
Guidance Documents
-
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.
With the start of the new year, Pharmaceutical Engineering is launching a new series of profiles of industry leaders. This ongoing series will look at the lives and careers of individuals who are changing the...
