Breaking News

Cardiff University launches cleanroom protocols CPD course

It is a short, asynchronous course, which participants can take in their own time, so is ideally placed to become part of an onboarding or inductio...

What happens when you fail to meet FDA data integrity standards?

Lighthouse Worldwide Solutions sheds light on what happens inside the regulatory world

Divi’s chooses Juniper Networks to improve API manufacturing network

Divi’s Laboratories has chosen the AI-driven network specialist to avoid dropped packets and network interruptions, and ensure the most stringent o...

Elimination of contaminants in GMP cleanliness classes and pharmaceuticals

Special requirements are directed towards production in high ISO/GMP purity classes, where the manufacturing process takes place under sterile cond...

New regulations on corporate due diligence in supply chains come into force in Germany

CWS says that a transparent and sustainable supply chain is particularly important in the textiles industry

Tickets now on sale for 2023 UK Cleanroom Technology Conference

Super early bird tickets are now on sale for the annual conference due to take place in Birmingham on 24 – 25 May 2023

12 reasons to transition to digital validation

Increased regulatory advocacy for futuristic workflow techniques is slowly overcoming the pharmaceutical industry’s hesitancy. Valgenesis' Lisa Wee...

Annex 1: Changes that will hit EM monitoring programmes

Since 2017, Annex 1 Manufacture of Sterile Medicinal Products of EU GMP Volume 4 has been undergoing significant revision. In August 2022, the revi...

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...

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...

Less haste more speed: cGMP commercial facility design in 2023

The advancement of drug development techniques coupled with the need to deliver potentially life-changing therapies to patients efficiently has mad...

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...

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...

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...

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...