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Global News
Baseline GuidesBaseline Guide Vol 3: Sterile Product Manufacturing Facilities 3rd Edition
Published: April 2018 Note: Bound version of this guide will be available 4 May 2018 Pages: 244 Table of Contents Special Pricing for Emerging Economies - Learn More The ISPE...April 24, 2018*/ /*--> */ A record-setting 640 attendees gathered in Rome...April 24, 2018View All News*/ /*--> */ A record-setting 640 attendees gathered in Rome in March for the 2018 ISPE Europe Annual Conference . More than 70 sessions offered the latest thinking on topics...April 23, 2018Continuous manufacturing of pharmaceuticals has been an extremely popular topic...April 23, 2018View All NewsContinuous manufacturing of pharmaceuticals has been an extremely popular topic in our field for the past ~ 10 years or so. You see it in heavily academic circles. You see...
Submit Your Facility
Has your company recently designed, built or renovated a state-of-the-art pharmaceutical or biotechnology facility that is best in its class? Submit an entry into the 2019 ISPE Facility of the... -
Global Events
June04
2018 ISPE Quality Manufacturing Conference
*/ /*--> */ FDA, MHRA, PMDA, & Industry Leaders Present...Crystal Gateway Marriott
June 04, 2018View All Events*/ /*--> */ FDA, MHRA, PMDA, & Industry Leaders Present on Data Integrity, Quality Metrics, & New Technologies in Global Manufacturing Environment Considered to be the paramount conference in the...June062018 ISPE Continuous Manufacturing Workshop
2018 ISPE Continuous Manufacturing Workshop Interest in continuous manufacturing of...Crystal Gateway Marriott
June 06, 2018View All Events2018 ISPE Continuous Manufacturing Workshop Interest in continuous manufacturing of pharmaceuticals has exploded in the past few years, fueled by the recent regulatory approvals of the first few drug products...May07ManufacturingPharmaceutical Technology Transfer Training Course
Technology transfer (TT) includes knowledge transfer, science and risk-based principles...May 07, 2018View All CoursesTechnology transfer (TT) includes knowledge transfer, science and risk-based principles including ICH Q8, Q9, Q10, Q11 and efficient processes to meet evolving business needs. As the industry continues to experience...May09GMPsManufacturingICH Q7A GMPs for Active Pharmaceutical Ingredients Training Course
Due to the growing pressures from global competitors, high marketing...May 09, 2018View All CoursesDue to the growing pressures from global competitors, high marketing demands, and the requirements of GMP compliance, the bio-pharm industry (brand drugs and generic drug companies) are looking beyond the... -
Most Popular
June04
2018 ISPE Quality Manufacturing Conference
*/ /*--> */ FDA, MHRA, PMDA, & Industry Leaders Present...Crystal Gateway Marriott
June 04, 2018View All Events*/ /*--> */ FDA, MHRA, PMDA, & Industry Leaders Present on Data Integrity, Quality Metrics, & New Technologies in Global Manufacturing Environment Considered to be the paramount conference in the...June062018 ISPE Continuous Manufacturing Workshop
2018 ISPE Continuous Manufacturing Workshop Interest in continuous manufacturing of...Crystal Gateway Marriott
June 06, 2018View All Events2018 ISPE Continuous Manufacturing Workshop Interest in continuous manufacturing of pharmaceuticals has exploded in the past few years, fueled by the recent regulatory approvals of the first few drug products...November042018 ISPE Annual Meeting & Expo
*/ /*--> */ 2018 ISPE Annual Meeting & Expo Hear...Philadelphia Marriott Downtown
November 04, 2018View All Events*/ /*--> */ 2018 ISPE Annual Meeting & Expo Hear first-hand from attendees on why the ISPE Annual Meeting & Expo is the must-attend pharmaceutical event of the year. The...
GAMPGAMP 5 Guide: Compliant GxP Computerized Systems
*/ /*--> */ Published: February 2008 Pages: 356 Table of Contents Supporting Materials Special Pricing for Emerging Economies - Learn More GAMP® 5 provides pragmatic and practical industry guidance to...
Guidance Documents
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Baseline Guide Vol 3: Sterile Product Manufacturing Facilities 3rd Edition
Baseline Guide Vol 3: Sterile Product Manufacturing Facilities 3rd Edition
Published: April 2018
Note: Bound version of this guide will be available 4 May 2018
Pages: 244 -
GAMP Good Practice Guide: Computerized GCP Systems & Data
GAMP Good Practice Guide: Computerized GCP Systems & Data
Published: December 2017
Pages: 128 -
GAMP Good Practice Guide: IT Infrastructure Control and Compliance
GAMP Good Practice Guide: IT Infrastructure Control and Compliance
Published: August 2017
Pages: 168 -
Baseline Guide Volume 7: Risk-Based Manufacture of Pharma Products
Baseline Guide Volume 7: Risk-Based Manufacture of Pharma Products
ISPE Blog
March 2018
IN THIS ISSUE Cover: Reining in Consumption for Sustainable Manufacturing The word “sustainability” is both overused and abused: We hear about sustain...