Regulatory

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”

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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

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...

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...

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...

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...

End of an era: EU GMP Annex 1 has been finalised and published

After 14 years of many consultation periods, drafts, and revisions, the EU standard for "The Manufacture of Sterile Medicinal Products" has been co...

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...

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...

Validair Diamond Scientific installs cleanroom for in-house testing, research & training

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

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...

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

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...