Regulatory

Breaking News

Cherwell publishes new guide to EM best practice

The eBook also includes an update to its section discussing how to achieve Annex 1 compliance in EM processes

TSS expands with acquisition of four cleanroom service providers

Technical Safety Services has acquired these cleanroom service providers in part to enable it to move ‘up-stream’ in a facility’s life cycle and no...

Hangzhou Semiconductor Wafer defends two lawsuits for cleanroom construction fees

China-based semiconductor wafer manufacturer Hangzhou Semiconductor Wafer has provided an update on two lawsuits from L&K Engineering and China Con...

Pharmaceutical regulatory warning letters: What can we learn post-COVID?

A looks at how the COVID-19 pandemic impacted FDA inspections and the trends that have now cropped up reflecting industry changes. Mirna Vazquez an...

Trescal reveals acquisitions across Asia, Europe, and Oceania worth $25m

The UK-based calibration expert has made its first acquisitions since EQT Infrastructure entered exclusive negotiations to acquire a majority stake...

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Selection criteria for cleanroom garments with the new Annex 1

For the first time since 2008, the GMP Annex 1 guidance for the manufacturing of sterile medicine products has undergone a profound revision. The r...

Regulatory warning letters in pharma: What can we learn post-COVID?

A look at how the COVID-19 pandemic impacted FDA inspections and the trends that have now cropped up reflecting industry changes. Mirna Vazquez and...

Abraxis Bioscience receives FDA warning

During the examination, FDA officials found that the company “failed to thoroughly investigate any unexplained discrepancy or failure of a batch”

FDA gives out 483 form to Torrent Pharma citing "inadaquate cleaning procedure"

The pharma giant from India has been give the form citing three main issues

A risk mitigation approach to detecting and quantifying metals in APIs

If trace quantities of metals are present in active pharmaceutical ingredients (APIs) or final drug products, they have the potential to adversely...

The regulations don't go far enough: Glove permeation testing in chemotherapeutics

Ansell Senior Director of Project Management, Eric Boeckmans, talks to Cleanroom Technology about why testing glove permeation ‘in-use’ is key to s...

ATI adds high flow paraffin option to automated filter test range

The new High Flow option has added greater flexibility for testing a wider range of masks and cartridges, including PAPR cartridges, and increases...

New standards for popular decontamination techniques

Peter Thistlewaite from MSL Solution Providers outlines the new and increasingly harmonised regulations for ultraviolet light and automated fogging...

Comecer completes FAT for key therapeutic radiopharmaceutical

TerraPower chose Comecer for the factory acceptance test for their groundbreaking technology to make possible a stable supply of the Actinium-225 t...

An ISO & CEN Cleanroom Standards developments rundown

A look at some of the recent major cleanroom standards revisions that will be important to know for your facility. chair of both BSI LBI/030 and CE...