Regulatory

CorMedix sees NDA approval delay due to CMO and API supplier issue

A Complete Response Letter (CRL) was received from the FDA stating that the DefenCath NDA cannot be approved until deficiencies recently conveyed to the contract manufacturing organisation and the supplier of the API heparin during inspections are resolved

Breaking News

Validair commissions cleanroom to research and refine consultancy techniques

Validair Diamond Scientific has commissioned Total Clean Air to build a cleanroom for R&D and training

CorMedix sees NDA approval delay due to CMO and API supplier issue

A Complete Response Letter (CRL) was received from the FDA stating that the DefenCath NDA cannot be approved until deficiencies recently conveyed t...

Aermec secures UKCA mark ahead of 2023 certification deadline

The HVAC provider has secured the certification for the new product marking required for the UK before the January 2023 deadline

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...

Ecolab unveils Global Intelligence Centre to drive IoT data management

Ecolab has transformed its System Assurance Centre, a single remote monitoring location, into the Ecolab Global Intelligence Centre (EGIC), an inte...

Lonza launches non-bovine test for non-endotoxin pyrogen contaminants

Lonza has launched the PyroCell Monocyte Activation Test that uses human serum instead of fetal bovine serum for pharmaceutical testing

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...

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...

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ValGenesis and Zenovative partner to digitise validation in pharma

The two companies have planned the partnership to combine Zenovative's Industry 4.0 expertise with ValGenesis' validation lifecycle management soft...

The impact of Annex 1 on environmental monitoring

The much-discussed revision to the EU GMP Annex 1 is hopefully nearing conclusion with the release of the document anticipated in early January 202...

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

Ansell Senior Director of Project Management, Eric Boeckmans, talks to <i>Cleanroom Technology</i> about why testing glove permeation ‘in-use’ is k...

Vicarious Surgical announces cleanroom qualification

The next-generation robotics company has chosen to substantially augment the company's existing capabilities by providing an environmentally contro...

The rules for validating a disinfectant

There are many acronyms that will be used when discussing disinfectants and their validation, FDA, EPA, BPR, AOAC, EN, EU GMP, USP, ASTM the list g...

MSL Solution Providers introduces efficacy testing of UV devices

Following the publication of BS 8628:2022, microbiological testing firm, MSL Solution Providers, is implementing the new industry standard for auto...

Clearing up the bioplastic confusion

In clean and sterile environments there is a need for a lot of single-use consumables that contain plastic, but this poses an obvious environmental...