01.14.21 Introduction To ASTM E3263-20 On Qualification Of Visual Inspection For Residues
This report helps biopharmaceutical companies make more informed CMO decisions and helps CMOs optimize operational and marketing strategies. ISR presents data on 509 service encounters from 179 respondents who have been involved in outsourced biologics API projects in the past 18 months. Learn more here.
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By Andrew Walsh, Ralph Basile, Ovais Mohammad, Stéphane Cousin, Mariann Neverovitch, and Osamu Shirokizawa
The new E3263 standard provides the science-, risk-, and statistical-based guidance and the tools needed for companies to implement the use of visual inspection within a quality risk management program that meets the criteria promulgated in the EMA s new Q&A 7 and Q&A 8.
Dr Stephen Humphreys
SIR – Do we now find ourselves having left the European Union and rejoined the Common Market, which is what I voted for originally?
C F Goodall
SIR – With some reluctance, I voted to leave the EU. The manner in which it has conducted negotiations since the UK voted for Brexit has done much to reassure me that I did the right thing.
Nigel Waterson
SIR – The person to be recognised for having brought about such a good Brexit deal is Lord Frost. As the EU has said, he has been a tough leader of the British negotiating team – but fair, too.
TRC Companies Selects Kent Kading as National Director of EHS Services
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TRC Companies ( TRC”), a leading end-to-end engineering, consulting, construction management, and technology services firm selects Kent Kading as National Director of Environmental, Health and Safety (EHS Services). With the addition of Kading to the environmental sector leadership team, TRC continues to focus on the enhancement and growth of its EHS compliance and management services offerings, including auditing programs, multi-media permitting services, health and safety consulting, management systems and digital services for EHS information systems. This strategic step will enable TRC to integrate EHS services with its existing air quality services, EHS compliance and industrial hygiene services. Additionally, Kading will be instrumental in helping TRC to deliver comprehensive EHS services to clients by leading and addressing the new and unique EHS challenges in the various market sectors of