Regulatory

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FDA Warning Letter: ImprimisRx facility features stained HEPA filters

Following a 2022 inspection, ophthalmic medicine production expert ImprimisRx received a 483 form. A year later a warning letter has been sent emph...

Validair Monitoring Solutions rebrands as FMS

The rebranding is set to better align the company's business with "strong growth in diverse market sectors"

Cherwell plans first truly portable real-time microbial monitor launch at May conference

The new portable Biofluorescent Particle Counter that has been designed to support EU GMP Annex 1 requirements will launch at this year's Cleanroom...

Warning Letters: Lessons from an FDA Captain

Redica Systems’ Jerry Chapman talks to FDA's Ileana Barreto-Pettit

MSL launches new SDS subscription service

The package includes alerts and notifications of upcoming changes, consultancy, an annual review to ensure they remain up to date, and a limited nu...

Micronclean goes green with 100% renewable electricity

The contract guarantees electricity from wind solar and hydro sources through the OFGEM approved Renewable Energy Guarantee of Origin (REGO) scheme

Cleanrooms in 2022: Highlights in the sector

In a year with repeated blows to the global population, the cleanroom industry showed its creativity and resiliency. With a pandemic hangover, a wa...

ISPE GAMP5 second edition: What’s new?

General Manager of Lighthouse Worldwide Solutions, EMEA Operations, Hasim Solmaz takes a detailed look at the recently published IPSE Good Automate...

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

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...

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...

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...

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...

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

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...