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02.16.21 -- Do These Recent Warning Letters Signal A Shift In FDA Enforcement?

02.16.21 Do These Recent Warning Letters Signal A Shift In FDA Enforcement?

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Featured Editorial
By Barbara Unger, Unger Consulting Inc.
The FDA posted two unique warning letters that all pharmaceutical and API firms, regardless of their product category, should consider and evaluate. These first-of-a-kind warning letters represent a renewed emphasis on both alternatives to on-site inspections and the importance of purchasing controls and supplier management. ....

Dominic Hyde , Stephen Natoli , Mark Robbins , Oliver Stauffer , Matthew Gorton , Hemi Sagi , Steve Wang , Zoltan Gulyas , Joshua Hicks , Sharon Nowak , Maaike Everts , John Simpson , Brian Stephens , Piergiuseppe Nestola , Bora Pharmaceuticals , White Paper Alconox Inc , Pfeiffer Vacuum Inc , Natoli Engineering Company Inc , Automated Systems Of Tacoma Inc , Pharma Services , Evonik Corporation , Automated Systems , Pfeiffer Vacuum , Thermo Fisher Scientific , Natoli Engineering Company , Sartorius Stedim ,

01.14.21 -- Introduction To ASTM E3263-20 On Qualification Of Visual Inspection For Residues

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.
Featured Editorial
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. ....

Josh Adams , Bob Mcdowall , Mark Robbins , Temitope Sodunke , Webinar Lonza Pharma , Brucec Simpson , Derek Duncan , Nephi Jones , Case Study Seeq Corporation , Bora Pharmaceuticals , Environmental Protection Agency , Services Inc , Application Note Silverson Machines Inc , Kalyan Potluri , Thermo Fisher , Kenneth Ball , Pfizer Centreone Contract , Stuart Ward , Damien Tiller , Hamilton Oneferm , Hyperforma Single Use Fermentors , Use Mixers , West Pharmaceutical Services , Anton Paar United , Meissner Filtration , Silverson Machines ,

12.15.20 -- Cleaning Process Development: Time To Clean Studies & The Cleaning Assurance Level For Pharmaceutical Products

12.15.20 Cleaning Process Development: Time To Clean Studies & The Cleaning Assurance Level For Pharmaceutical Products

ISR’s Health Panel includes managers, directors, executives, and subject matter experts in clinical development and drug manufacturing who work at pharma companies, service provider companies, and research sites. Members are paid for their time (a 15-minute survey may be $40, whereas a 45-minute phone interview may be $150) and they get to choose which research opportunities to participate in. Apply here.
Featured Editorial
By Ruijin Song and Andrew Walsh, Center for Pharmaceutical Cleaning Innovation (CPCI)
A simple time-to-clean study can provide a rapid and efficient way to evaluate the behavior of a product during cleaning and obtain a reasonable estimate of the actual amount of time needed to achieve acceptable cleaning. ....

Mario Scigliano , Nadezda Perepelitsa , Rob Rogers , Deanna Mudie , Matt Hicks , Yves Massicotte , Christian Ahlmark , Simon Chen , Piergiuseppe Nestola , Bora Pharmaceuticals , Cordenpharma International , Ropack Pharma Solutions , Application Note Micromeritics Instrument Corporation , White Paper Nuaire Inc , Equipment Company , Article Promega Corporation , Federal Equipment , Sartorius Stedim , Mettler Toledo Product , Ropack Pharma , Thermo Fisher , Bright Yellow , Meissner Filtration , Micromeritics Instrument , மரியோ ஸ்ஸிகிலியானோ , கொள்ளை ரோஜர்ஸ் ,