Below are the top ten articles from the PDA Journal of Pharmaceutical Science and Technology for the month of August.
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PDA Paper
“PDA Points to Consider: Best Practices
for Document/Data Management and
Control and Preparing for Data Integrity
Inspections”
-
Review
“Particulate Matter in Injectable Drug
Products”
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PDA Paper
“Industry Perspective on the Medical Risk
of Visible Particles in Injectable Drug
Products”
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Conference Proceeding
“Role of Risk Assessments in
Viral Safety:
An FDA Perspective”
-
Research
“Vapor Phase Hydrogen Peroxide Decontamination or Sanitization of an Isolator
for Aseptic Filling of Monoclonal Antibody
Drug Product—Hydrogen Peroxide Uptake
and Impact on Protein Quality”
-
PQRI Special Section –
Review
“
The Product Quality Research Institute
(PQRI) Leachables and Extractables
Working Group Initiatives for Parenteral and
Ophthalmic Drug Product (PODP)”
-
PQRI Special Section –
Research
“Extractables Characterization for Five
Materials of Construction Representative
of Packaging Systems Used for Parenteral
and Ophthalmic Drug Products"
-
Research
“Sealing Behaviour of Container Closure
Systems under Frozen Storage Conditions:
Nonlinear Finite Element Simulation of
Serum Rubber Stoppers”
-
Technology/Application
“Ozone Generation during High-Voltage
Leak Detection: Fiction or Reality?”
-
Research
“Determination of the Acceptable Ambient Light Exposure during Drug Product
Manufacturing for Long-Term Stability of
Monoclonal Antibodies”