Articles by John Anderson - Pharmaceutical Technology

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Articles by John Anderson

Defining and Presenting Overkill Cycle Validation

Autoclave overkill cycles should be validated by correlating lethality data to support chosen critical process parameters.
Nov 2, 2013

Sterilization validation must be based on a robust, quality-by-design philosophy; autoclave overkill cycles should be validated by correlating lethality data to support chosen critical process parameters, even when using overkill sterilization.

Choosing Overkill Cycle Parameters

Oct 16, 2013

Parameters for steam-sterilization autoclave overkill cycles should be chosen based on process understanding.

Classifying Rouge Helps Define Remediation Procedures

Identifying and classifying rouge can help to determine CAPA.
Sep 2, 2012

Identifying and classifying rouge can help to determine CAPA.

Classifying Rouge Aids in Determining Maintenance and Remediation Procedures

Properly identifying and classifying rouge, a form of surface corrosion that comes in many forms, is important in determining whether it may be affecting product quality and whether further actions are necessary.
May 16, 2012

Properly identifying and classifying rouge, a form of surface corrosion that comes in many forms, is important in determining whether it may be affecting product quality and whether further actions are necessary.

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Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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