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The IDMP data standards aim to standardise the submission of data on medicinal products. Remco Munnik, Associate Director at Iperion, has been working with the EU focus group creating the EU IDMP Implementation Guide version 2, published late February. He explains why pharma companies need to act now in response…
Learn how Process Analytical Technology (PAT) and real-time TOC testing of pharmaceutical grade water systems can improve efficiency.
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The Indian drug company pleaded guilty to concealing and destroying records containing evidence of its Kalyani plant manufacturing drugs in contravention to FDA requirements prior to a 2013 inspection.
9 February 2021 | By Sartorius
During this on-demand webinar we discuss how to achieve data integrity and give real examples from the US Food and Drug Administration (FDA) warning letters about the most frequent and typical violations.
See how a leading biochemistry company implemented real-time microbial monitoring to streamline process control in their water system.
Total Organic Carbon (TOC) analysis is used to comply with compendia water testing requirements. Read this document to learn the basics on TOC.
Here are five ways to ensure a successful and compliant cleaning validation program.
A group of hackers has sent phishing emails to various people involved in COVID-19 vaccine cold chain distribution to gain insight, IBM has revealed.
An overview on the role of BPOG extractables data in the effective adoption of single-use systems in biomanufacturing
A report has found that the biggest hurdle for digital transformation in pharma is a lack of specific skills and talents, followed by organisational silos.
6 November 2020 | By IDBS
Join our virtual roundtable panel where we discuss best practices and experiences of digital transformation, as well as exploring how digital transformation can help accelerate decision making, optimise processes and remove operational inefficiencies.
Take our 10-question quiz to find out how efficient your Total Organic Carbon (TOC) monitoring programme is for your applications.
Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts.
Watch the webinar that analyses the most important points introduced by the newest USP Chapter 1085 on endotoxin testing guideline and their impact.
Data integrity (DI) continues to trend as a hot topic for pharmaceutical manufacturers, despite the fact it is an expectation that has been present for years.
