Troubleshooting - Pharmaceutical Technology

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PharmTech

Latest Issue
PharmTech Europe

Troubleshooting

Multifactor Non-linear Modeling for Accelerated Stability Analysis and Prediction

July 2, 2014

Pharmaceutical Technology

The right approach can provide a clear, statistically defendable method for determining dissolution and accelerated stability.

Understanding the Cleaning Validation Lifecycle

April 16, 2014

Equipment and Processing Report

The cleaning validation lifecycle includes assessment, development, validation, and monitoring.

Defining the Sterile Barrier of Complex Drug Delivery Systems

March 17, 2014

Equipment and Processing Report

New injection-delivery systems with multiple closure points pose challenges for container closure integrity testing.

Separation of Compliance and Performance Under FDASIA

March 2, 2014

Pharmaceutical Technology

The root cause of drug shortages is mismanagement of variation.

Checklist for Computer Software Validation

February 2, 2014

Pharmaceutical Technology

Non-compliance issues show that users find dealing with computer systems challenging.

Battling Off-Weight Tablets

January 2, 2014

Pharmaceutical Technology

Training, calibration, and preventive maintenance help prevent over-and under-weight tablets. The author discusses causes of off-weight tablets and best practices for tableting.

Using Analytical Techniques to Examine Tablet Sticking

December 2, 2013

Pharmaceutical Technology

Analytical tests, correlated with statistical techniques, are used to predict material behavior.

Operational Excellence Improves Quality and Compliance

November 20, 2013

Equipment and Processing Report

An operational-excellence initiative increased collaboration between operations and quality personnel to address human-error-caused deviations.

Defining and Presenting Overkill Cycle Validation

November 2, 2013

Pharmaceutical Technology

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.

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Survey
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
35%
Breakthrough designations
12%
Protecting the supply chain
35%
Expedited reviews of drug submissions
12%
More stakeholder involvement
6%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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