| PEER-REVIEWED RESEARCH |
Pramote Cholayudth
The working acceptance limits for acceptance values (AV) are determined using the critical values at, for example, 95% coverage over the corresponding AV distributions. However, validity of such limits needs to be elaborated.
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| ASEPTIC MANUFACTURING |
Manuel M. Garza
Airflow visualization studies confirm unidirectional airflow patterns in an aseptic processing facility.
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| DATA INTEGRITY |
Don DiPalma, Jeff Vannest
Integrated computerized systems for data collection improve data security and offer a solution for handling temporary data.
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| PACKAGING |
Hallie Forcinio
Updated guidelines and new technologies aid visual inspection of parenteral products and packaging.
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| SUPPLY CHAIN |
Elisabeth Vachette, Frederic Bazin, Magali Barbaroux, Jean-Marc Cappia
Increased use of single-use systems has led to a need to redefine safe, stable and integral systems for shipping biopharmaceuticals around the world. This article provides qualification data under international ASTM D4169 norms.
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| EU REGULATORY WATCH |
Sean Milmo
The European Union is collaborating with the Pharmaceutical Inspection Co-operation Scheme to develop similar guides for evaluating inspectorates’ competency.
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| US REGULATORY WATCH |
Jill Wechsler
FDA’s commissioner addresses opioid abuse, drug costs, and manufacturing quality.
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| OUTSOURCING OUTLOOK |
Jim Miller
CDMOs can claim credit for the robust growth of emerging bio/pharma financings.
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| ASK THE EXPERT |
Siegfried Schmitt
Monetary benefits will outweigh the hassle of batch record harmonization, says Siegfried Schmitt, principal consultant at PAREXEL.
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