Recent ISPE Good Practice Guide Changes: Controlled Temperature Chambers Commissioning and Qualification, Mapping and Monitoring (2021).

Recent ISPE Good Practice Guide Changes: Controlled Temperature Chambers Commissioning and Qualification, Mapping and Monitoring (2021).

ByNiamh

What were the changes? In 2021, ISPE Good Practice Guide: Controlled Temperature Chamber Mapping and Monitoring (2016) was updated, to become ISPE Good Practice Guide: Controlled Temperature Chambers Commissioning and Qualification, Mapping and Monitoring (Second Edition, 2021). The addition of “Commissioning and Qualification” to the title reflects the additional focus that these activities receive in…

ValGenesis and PharmOut Announce a Partnership Founded on a Paperless Validation Initiative.

ValGenesis and PharmOut Announce a Partnership Founded on a Paperless Validation Initiative.

ByTrevor

New partnership offers cost-effective paperless validation to GMP – governed organisations in Australia. PharmOut, the Asia Pacific’s leading Pharmaceutical consulting organization, has announced a strategic partnership with ValGenesis Inc, a pioneer in paperless validation software systems. Pharmaceutical, medical device and other GMP-compliant industries incur considerable costs in creating, maintaining and storing the mountain of paper-based…

Virtual Qualification and Pharma 4.0® Thinking During Lockdown
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Virtual Qualification and Pharma 4.0® Thinking During Lockdown

ByPharmOut

Virtual Qualification, how can Pharma 4.0® thinking help during Covid-19 lockdown and what lessons can we apply to virtual qualification? The events of Covid-19 have opened up a new world of vulnerability to all industries, and especially those highly regulated like the medicinal products manufacturers and the possibility of Pharma 4.0® Virtual Qualification as a…

Senior GMP and Validation Consultant
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Senior GMP and Validation Consultant

BySteve

Congratulations Colin Byrne PharmOut is delighted to announce that Colin Byrne has been promoted to the role of Senior Consultant. Colin has over 12 years of experience in the pharmaceutical industry, including more than 4 with PharmOut. He has gathered a wealth of experience in equipment qualification, process validation, and compliance, most notably in sterile…