On 25 August 2023, the long-awaited revision to Annex 1 became effective, introducing significant regulatory changes, including the requirement of a documented contamination control strategy (CCS). During a workshop at the 2023 ISPE Annual Meeting & Expo, 11 teams of attendees were presented with a risk-based methodology to develop and evaluate CCS elements focused on extrinsic...
The expectations for room differential pressures to maintain air quality in pharmaceutical facility design are consistent and well defined from a regulatory perspective. However, there is no common approach to the design, monitoring, or alarming of area differential pressures. This article explores differential pressure concerns in aseptic manufacturing, or cleanroom classes B, C, and D.
Artificial intelligence (AI) is used by pharmaceutical and biotech companies, providing support from drug discovery through manufacturing. The nature of AI and concerns of bias, privacy, transparency, and security in a regulated industry necessitate a governance framework to ensure concerns are controlled using “guardrails.” These guardrails ensure the quality, privacy, and security of data...
In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Matt Lehmann, Custom Training Manager, Professional Development.
This year, the ISPE Foundation made great strides in its mission of fueling global health equity by fostering access to knowledge and nurturing diverse talent.
In 2019, ISPE released the Second Edition of the ISPE Baseline® Guide Vol 5: Commissioning and Qualification. This guide mirrors the industry’s evolution toward harmonizing with latest...
The new ISPE Good Practice Guide: Unique Identification of Glass Primary Containers in Pharmaceutical Fill and Finish Operations involved a cross-functional team of industry experts and professionals from parenteral/injectable medicine manufacturing. The team included industry competitors who worked together to establish a common approach. They provided a balanced, industrywide perspective on...
In April 2024, ISPE published the ISPE Guide: 503A Compounding - Regulatory Basis and Industry Good Practices for Pharmacies, adding to the growing body of knowledge ISPE is producing for the pharmaceutical compounding industry. Written by industry experts and reviewed by practitioners in the area, the guide provides an overview of relevant US Food and Drug Administration (FDA) regulations and...
Rod Freeman started his career in the pharma-ceutical industry as an analytical chemist.
Growing up on a farm, Allen Koester thought he would design farm equipment after earning his degree in mechanical engineering.
