Pharmaceutical Technology, Sep 1, 2011 - Pharmaceutical Technology

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Pharmaceutical Technology, Sep 1, 2011
Manufacturing Perspectives: Lessons for Biomanufacturing from Small-Molecule Manufacturing
By Lou Schmukler
A perspective from Pfizer on the lessons from small-molecule manufacturing that can be applied to biomanufacturing.
Building Technology Positions in API Manufacturing
By Patricia Van Arnum
As contract manufacturers and fine-chemical suppliers gather for CPhI/ICSE, effective strategies for technology differentiation are key in an increasingly competitive environment.
FDA's New Process Validation Guidance: Industry Reaction, Questions, and Challenges
By Mike Long , Hal Baseman , Walter D. Henkels
The authors desribe the three-stage approach to validation that is outlined in the new guidance and discuss questions surrounding implementation.
The Determination and Control of Genotoxic Impurities in APIs
By V. Gangadhar , Y. Pardha Saradhi , R. Rajavikram
The authors provide an overview of methods for the quantitative determination of genotoxic impurities (GTIs) in active pharmaceutical ingredients.
Sample Preparation for Quantitative Metal Impurity Testing
By Gayla Velez
The author examines sample-preparations methods used in inductively coupled plasma–optimal emission spectroscopy for four test metals.
Achieving Containment in High-Potency Manufacturing: A Case Study for Solid Dosage Manufacturing
A Q&A with Joe Cascone, director of potent pharmaceutical development at Metrics, moderated by Patricia Van Arnum. Discussion of the key considerations made in facility design, equipment selection, and operations to achieve desired levels of containment.
A Supplier's Role in Ensuring and Improving Excipient Quality
By Frithjof Holtz , Najib Sehat
Excipients are the hidden champions of drug development—no API works consistently without the right excipient. Pharmaceutical excipients, however, require stringent quality management. This article discusses how the supplier of pharmaceutical raw materials should take a central role in ensuring excipient quality.
Addressing Ways to Improve Supply-Chain Security: A Perspective from Pfizer
A Q&A with Brian Johnson, senior director of supply chain security at Pfizer, moderated by Patricia Van Arnum. Part of a special Ingredients issue.
Atypical Actives Gain Attention
By Angie Drakulich
Clarifying GMPs for excipients used as actives.


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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
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Expedited reviews of drug submissions
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Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
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Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
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