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-use...
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 and...
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...
Announcing the release of our latest guidance document, ISPE GAMP ® Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition). This guide provides guidance on meeting regulatory expectations for compliant IT (Information...
ISPE announced the release of their latest guidance document, ISPE Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Second Edition). This guide provides a scientific, risk-based approach (based on ICH Q9 Quality Risk Management)...
ISPE has announced the third edition of the ISPE Baseline® Guide: Oral Solid Dosage (OSD) Forms. This newly revised guide is available in book and PDF format. “The key takeaway for the OSD Baseline® Guide is to give owners, engineers, and equipment...
