ISPE Briefs - ISPE Launches Complimentary Webinar Series

The first webinar on 29 April 2019 was “Water for Injection Using Non-Distillative Methods—ISPE D/A/CH Approach,” presented by Fritz Röder, Senior QA Manager Validation, Qualification, and Engineering at Merck KGaA, Darmstadt, Germany. Röder shared collective insights from the ISPE D/A/CH (Germa-ny/Austria/Switzerland) Affiliate’s Regional Community of Practice, Water and Steam, and provided answers to questions such as ,“What are suitable technologies for the final treatment step of a cold water-for-injection system?”

ISPE will be hosting monthly webinars featuring leading subject matter experts covering critical and relevant topics in pharmaceutical manufacturing.

Upcoming topics include:

• New GAMP® Data Integrity Good Practice Guidance and Experience from the Field
• GAMP® Good Practice Guide for GxP Compliant Lab Computerized System
• Polishing an Old Gem: Commissioning & Qualification Baseline Guide Update

ISPE members will have access to the recorded webinars on the ISPE website. Visit webinars to learn more and to sign up to be notified when registration opens for each webinar.

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Newest Good Practice Guide: Data Integrity–Manufacturing Records

The newly released ISPE GAMP® Records and Data Integrity Good Practice Guide: Data Integrity—Manufacturing Records addresses the expectations for data integrity in a GMP environment to aid companies in meeting regulatory requirements.

This guide provides a manufacturing business process framework to:

• Facilitate interpretation of regulatory requirements and expectations based on industry best practices
• Define the data integrity approach for planning and project activities
• Apply risk management to all aspects of the data life cycle
• Identify roles and responsibilities to manage the data within the data life cycle
• Develop an appropriate data strategy for manufacturing IT systems

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Call for Articles: Submit Your Article to Pharmaceutical Engineering magazine

Pharmaceutical Engineering magazine is always looking for great technical articles, features, and editorials on topics of interest to ISPE members. Find the Author Guidelines and more information about submissions. Your article does not have to be related to an issue’s theme, although we welcome submissions on theme. Questions about submitting? Contact Susan Sandler, Editorial Director.