Connecting Pharmaceutical Knowledge
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Feature
Charlotte Enghave Fruergaard, PhD Part...09 January, 2019Charlotte Enghave Fruergaard, PhD Partner, Compliance Consulting NNE Charlotte Enghave Fruergaard joined ISPE in 1995. A member of th... View All Blog Posts09 January, 2019
Clinical trials becoming more complex and protocols are more dema...08 January, 2019Clinical trials becoming more complex and protocols are more demanding than ever. Long-term participation/commitment and frequent travel to investigator sites is a critical el... View All Blog Posts08 January, 2019
As we approach the end of this year, we want to thank each of you...19 December, 2018As we approach the end of this year, we want to thank each of you—members, volunteers, leaders, and staff. We appreciate your great work, commitment, and dedication, which hav... View All Blog Posts19 December, 2018
2018 ISPE Biopharmaceutical Manufacturing Conference on 10-12 Dec...19 December, 20182018 ISPE Biopharmaceutical Manufacturing Conference on 10-12 December in Huntington Beach, California, provided information about the future-oriented developments in the burg... View All Blog Posts19 December, 2018 -
Calendar Of Events
February07
2019 ISPE Facilities of the Future Conference
2019 ISPE Facilities of the Future Conference The 2019 Facilities...Hilton San Francisco Union Square
February 07, 2019View All Events2019 ISPE Facilities of the Future Conference The 2019 Facilities of the Future Conference will explore what pharmaceutical manufacturing facilities will look like in the future, featuring inspirational presentations from...March182019 ISPE Aseptic Conference
2019 ISPE Aseptic Conference Next Steps in Future of Aseptic...Bethesda North Marriott Hotel and Conference Cente
March 18, 2019View All Events2019 ISPE Aseptic Conference Next Steps in Future of Aseptic Processing: Containment, Multi-Product Facilities, & Robotics The 2019 ISPE Aseptic Conference, now in its 28th year, focuses on the future...February20FacilitiesProject ManagementPharma Facilities Project Management Training Course
This classroom course aims to deliver more than the usual...February 20, 2019View All CoursesThis classroom course aims to deliver more than the usual project basics and will develop the concept of the project lifecycle from initiation through to delivery of business benefits, providing...April04GAMP®GAMP® Data Integrity 21 CFR Part 11 Training Course
The importance and amount of data being generated to ensure...April 04, 2019View All CoursesThe importance and amount of data being generated to ensure product quality and patient safety continues to grow and proper controls around that data continue to be questioned. Regulatory agencies... -
Most Popular
GAMP Good Practice GuidesGAMP Good Practice Guide: Electronic Data Archiving
Published: July 2007 Pages: 152 Table of Contents Special Pricing for Emerging Economies This Guide provides a rational and scaleable approach to electronic data archiving through the development of an...
Good Practice GuidesGood Practice Guide: Packaging, Labeling, & Warehousing Facilities
The ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities is the industry's only guidance relating to the design, construction and commissioning and qualification of packaging, labeling and warehousing (PACLAW) facilities.
GAMP Good Practice GuidesGAMP Good Practice Guide: Operation of GxP Computerized Systems
Published: January 2010 Pages: 216 Table of Contents Special Pricing for Emerging Economies During the operational life of a GxP system regulators usually focus on the integrity, consistency, and completeness...
Good Practice GuidesGood Practice Guide: Project Management for Pharmaceutical Industry
The ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry provides good practice approaches which promote the successful integration of GxP with relevant project management activities to ensure that compliance risk is managed effectively and proactively.
Guidance Documents
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Good Practice Guide: Technology Transfer 3rd Edition
Good Practice Guide: Technology Transfer 3rd Edition
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 method development activities and transfer the knowledge to a different location where a process or analytical procedure will be operated. -
Good Practice Guide: Single-Use Technology
Good Practice Guide: Single-Use Technology
Single-use technology has grown in both complexity of design and criticality of application in the past twenty years, offering increased flexibility while significantly reducing the risk of contamination in manufacturing equipment. The implementation of single-use technology into a process requires a well-defined plan that minimizes surprises during the later stages of implementation. -
GAMP RDI Good Practice Guide: Data Integrity - Key Concepts
GAMP RDI Good Practice Guide: Data Integrity - Key Concepts
Published: October 2018
Pages: 196 -
Japan Affiliate: Pest Control Manual
Japan Affiliate: Pest Control Manual
The ISPE Japan Affiliate Manual on Pest Control expands on the concepts and policies set forth in the previous ISPE Japan Affiliate Handbook on Pest Control (English Translation, version 4) and offers advice for new and aging GMP facilities. It proposes plans for incorporating pest control best practices into the project schedule for new construction, including advice on integrating pest control requirements during all phases of construction, training construction staff, and determining areas to inspect both during and at the end of construction.
Call for Comments
Revised Draft PIC/S Guidance on Good Practices for Data Management and Integrity
The purpose of the guidance is to outline the position an inspector would adopt during the inspection of GDP/GMP facilities and is designed to facilitate a harmonized approach to the inspection, including reporting in regard to data management and integrity.
Commenting deadline: 28 Feb
A corporate culture that supports creative thinking can help pave a road to innovation. Free people from fear and encourage them to do their best and you’ll have an environment for accomplishing great things, according...
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Whether networking at events or collaborating through our Communities of Practice, the value of an ISPE membership is in the connections made between pharmaceutical industry professionals and Regulators to collaborate on solutions to common goals and challenges.
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