Articles by John Anderson - Pharmaceutical Technology

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Articles by John Anderson

John Anderson

John Anderson is a quality assurance and validation professional with years of inspection experience.

Defining and Presenting Overkill Cycle Validation
November 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
October 16, 2013

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

Classifying Rouge Helps Define Remediation Procedures
September 2, 2012

Identifying and classifying rouge can help to determine CAPA.

Classifying Rouge Aids in Determining Maintenance and Remediation Procedures
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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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
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