Dave DiProspero, Co-Team Leader of the ISPE Baseline® Guide: Oral Solid Dosage Forms (Third Edition), offers insight about what brought on the update and what core takeaways you’ll get from the new edition of this Guide...
ISPE announced the release of their latest guide, ISPE GAMP® RDI Good Practice Guide: Data Integrity – Manufacturing Records . This guide features the expectations and requirements for data integrity and quality management in GMP facilities. Industry...
Hear from two of the guide contributors, Gordon Leichter, PhD, Belimed Life Sciences and Jason Collins, AIA, IPS, on what you will take-away from purchasing this guide including practical and regulatory guidance...
Guide contributor (co-lead) Robert Beall, PMP, ProPharma Group, shares why process validation is an essential part of the pharma industry and how you’ll benefit from the ISPE Good Practice Guide: Practical Implementation...
ISPE announced the release of their latest guide, ISPE Good Practice Guide: Practical Implementation of the Lifecycle Approach to Process Validation . This guide provides professional insights for fundamental principles, process lifecycle approaches...
ISPE announced the release of their latest Guide, ISPE Good Practice Guide: Technology Transfer 3rd Edition . This Guide provides industry good practices for successful and efficient execution of technology transfer projects. “Transfer of...
ISPE announced the release of their latest Guide, ISPE Good Practice Guide: Single-Use Technology . This Guide provides a roadmap for efficient implementation of single-use technology (SUT) with minimum disruptions to existing operations. " Single...
ISPE announced the release of their latest Guide, ISPE GAMP ® RDI Good Practice Guide: Data Integrity – Key Concepts . This publication provides detailed practical guidance to support data integrity within a regulated organization. "In recent years...
ISPE announced the release of their latest Guide, ISPE Baseline ® Guide: Sterile Product Manufacturing Facilities (Third Edition) . This publication provides guidance on engineering facets of designing new sterile products manufacturing facilities...
ISPE announced the launch of their new online Guidance Documents Portal . For the first time, the entire library of Guides—including GAMP ® 5—can be accessed and searched online. In addition, the Society has made access to select ISPE Good Practice...
