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....
Pharmaceutical Engineering® is delighted to announce the finalists for the 2020 Roger F. Sherwood Article of the Year...
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...
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.
The San Francisco Bay Area Chapter has won numerous ISPE Awards by virtue of their contributions to the pharmaceutical industry. They continue to have their finger on the pulse of the local industry and respond with innovative and educational programs. The Chapter’s Emerging Leaders Committee is...
Takeda Pharmaceuticals International AG is the 2021 Facility of the Year Awards Winner for Process Intelligence & Innovation for their F36 New Solid...
Does your company only focus on how to get the product to patient without considering what happens if product needs to be retuned?
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from August 2021. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
ISPE is a global industry leader in scientific, technical, and regulatory advancement throughout the entire pharmaceutical lifecycle. As a result, ISPE is in a strong position and available to assist the US government, its allies, and like-minded regulatory partners with implementation of recommendations emerging from a report,
