ISPE’s Pharma 4.0™ initiative provides guidance, aligned with the regulatory requirements specific to the pharmaceutical industry, to accelerate Pharma 4.0™ transformations. Also known as the Smart Factory, the objective of Pharma 4.0 is to enable organizations involved in the product lifecycle to leverage the full potential of digitalization to provide faster innovations for the benefit of...

One of the most significant changes to the pharmaceutical industry in the last decade has been the increased speed in developing new therapies. A striking example of this is the rapid rollout of the COVID-19 vaccines. What usually took 10-15 years was researched, developed, and put into production in less than a year after scientists successfully revealed the virus's genetic code in January of...

Biocon Biologics is one of the 2021 Facility of the Year Awards Winner for the 2021 Facility of the Year Honorable Mention Award for their Biocon Biologics Manufacturing (B3) project in Bangalore, India.

ICH Q10 outlines three objectives: achieve product realization, establish and maintain a state of control, and facilitate continual improvement. Embracing these objectives can be best achieved using the dual enablers, Knowledge Management (KM) and Quality Risk Management (QRM). The pharmaceutical industry has made significant progress in adopting QRM into systems and processes. However, the...

Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are highlights from the magazine ten years ago in 2011. Revisit articles on single-use in biomanufacturing, contained...

Pharmaceutical Engineering® magazine is proud to announce the 2020 Roger F. Sherwood Article of the Year is “

Grand River Aseptic Manufacturing is the 2021 Facility of the Year Awards Winner for 2021 Special Recognition Award for Operational...

The strength of ISPE’s global network of Affiliates and Chapters is critically important in achieving ISPE’s mission to be the global industry leader in connecting pharmaceutical knowledge to deliver manufacturing and supply chain innovation, operational excellence, and regulatory insights to enhance industry efforts to develop, manufacture, and reliably deliver quality medicines to patients....

Apply for an ISPE grant to attend the 2021 ISPE Annual Meeting & Expo and a one-year ISPE Membership.

If you have less than five years of experience in the pharmaceutical or life sciences industry, you could be eligible to receive a grant to attend the

Pharmaceutical Engineering^® is delighted to announce the finalists for the 2020 Roger F. Sherwood Article of the Year...

Introduction

The U.S. Food and Drug Administration (FDA) has announced the reorganization of the agency’s information technology (IT), data management and cybersecurity functions into the new

Gilead Sciences, Inc. is the 2021 Facility of the Year Awards Winner for 2021 Special Recognition Award for...

Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are a look back at past winners of the Roger F. Sherwood Pharmaceutical Engineering Article of the Year Award.

This week ISPE released The ISPE GAMP^® Good Practice Guide: Enabling Innovation – Critical Thinking, Agile, IT Service Management. The first such guidance to discuss...

Pharmaceutical Engineering® magazine is proud to announce the 2019 Roger F. Sherwood Article of the Year is “

Government Pharmaceutical Organization is the 2021 Facility of the Year Awards Winner for Social Impact for their Biological Produce (Vaccine) Production Plant in Saraburi Province,...

Janssen Sciences is the 2021 Facility of the Year Awards Winner for Project Execution for their BioCork2 – Large Scale Fed Batch Facility...

The needs of patients must always be at the forefront of what we do.

Many of our colleagues are taking on the challenge of rethinking the old ways. They are collaborating with each other and the regulatory agencies to take effective steps to remain at the forefront of regulatory science and innovation. Why? In order to ensure the continued delivery of effective medicines.