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July 04, 2023

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Annex 1 Environmental Monitoring Common Questions and Answers

The newly published Annex 1 comes into effect this August 2023. Particle Measuring Systems have been involved in discussions with industry and regulatory focused teams defining how best to address the new elements of environmental monitoring to meet these new requirements. Join environmental monitoring expert Mark Hallworth as he shares frequently received questions along with practical answers to help you meet your EM needs.

	Industry News

Sandoz Launches Hyrimoz® High-Concentration Biosimilar
Sandoz announced that the citrate-free high-concentration formulation (HCF) of its biosimilar ... read more »

Bausch + Lomb to Acquire XIIDRA®
Bausch + Lomb Corporation has entered into a definitive agreement with Novartis under which Bausch +... read more »

FDA Updates List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic
On June 13th, the FDA published an update to the “List of Off-Patent, Off-Exclusivity Drugs without ... read more »

Almac Group Signs Up to Science Based Targets initiative
Almac Group announced joining the Science Based Targets Initiative (SBTi), which defines and ... read more »

	QC Corner

QC Corner: Automated Data Integrity in Sterility Testing
Pharma 4.0 transformation processes are reaching microbiological QC labs, using automation, robotics... read more »

	Infographic

Pharma Tech Compare: MMS vs Traditional IR
Download this infographic to read about four key benefits that distinguish MMS from traditional IR methods. read more »

	Featured Articles

		Building a Strong Data Foundation for Decentralized Clinical Trials with an FSP Model By bringing trials directly to patients, decentralized clinical trials (DCTs) offer a host of compelling benefits, including reduced patient burden, ... read more »

		Next-Generation Cell Line Development for Biotherapeutics Applications: Driving Precision and Productivity from the Molecular Level Drug development has evolved significantly over the past couple of decades, particularly within the large molecule biotherapeutics arena. In a growing... read more »

	Featured Video

On-Demand Webinar: Annex 1 Environmental Monitoring Common Questions and Answers
In this live webinar, hear from Mark Hallworth, GMP Scientific Advisor from Particle Measuring Systems as he addresses Annex 1 Environmental ... watch »

Watch Video: Humidity Calibration and the Indigo Platform
In this video, hear from Kevin Walsh, Application Sales Engineer from Vaisala as he talks about the humidity calibration and the Indigo platform in ... watch »

	Featured Products

Aquarius™ Genesis Film Coating System
Ashland Inc. Aquarius™ Genesis film coating systems are designed for application at up to 35% solids, which can ... learn more »

BRAND® HandyStep® Touch Electronic Repeating Pipette
BRANDTECH® Scientific The BRAND® HandyStep® Touch and Touch S are the first electronic repeating pipettes with touchscreen... learn more »

Kilian KTP 590X Rotary Tablet Press
Romaco Group KTP 590X single-sided rotary press from Romaco Kilian for mono- and bi-layer mode The cool – fast – ... learn more »

	Featured Whitepaper

eBook: Enhancing Impurity Control with Data Management
Pharmaceutical development teams must demonstrate a comprehensive understanding of impurities found in their medication. This requires high-quality data, but handling the necessary information is a ... read more »

Whitepaper: Adopting the Monocyte Activation Test for Sustainable Pyrogen Testing
Adopting the Monocyte Activation Test (MAT) for rabbit-free pyrogen testing of pharmaceutical preparations is highly encouraged for meeting product safety demands. This White Paper draws on an ... read more »

	More Products

280-DS Mechanical Qualification System Learn More
Discovery Thermogravimetric Analyzer 5500 Learn More
Elix 20 Water Purification System Learn More

	Directory Categories

Automated Sample Dilution Equipment Search More

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Bioprocessing Search More

	Events

AAPS PharmSci 360
Orlando, FL – 10/22/2023
PharmSci 360 delivers research from across the pharmaceutical continuum, from discovery to delivery, and all stages in between. Thousands of ... event details »

Bio-IT World Conference & Expo Europe
London, England – 11/29/2023
Bio-IT World Conference & Expo Europe unites a community of leading life sciences, pharmaceutical, clinical, healthcare, informatics, and technology ... event details »

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