QC/QA - Pharmaceutical Technology

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PharmTech

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PharmTech Europe

QC/QA

Innovations Abound

July 2, 2007
Pharmaceutical Technology

Here's a look at some of the most interesting and thematic responses you—our readers—provided for Pharmaceutical Technology's anniversary survey of industry advances and directions.

Signature Authentication Can Restore Confidence

June 2, 2007

Pharmaceutical Technology

Signature authentication technology has evolved to become a stong tool for improving confidence in verification.

ExcipientFest Attendees Discuss Regulatory and Quality Concerns

April 27, 2007

ePT--the Electronic Newsletter of Pharmaceutical Technology

San Juan, PR (Apr. 25)-Regulatory and quality issues were prominent discussion topics at this year?s ExcipientFest conference and exhibition.

Acceptable Analytical Practices for Justification of Specifications

April 2, 2007

Pharmaceutical Technology

The concept of Acceptable Analytical Practices (AAPs) was developed by the Analytical Technical Group of the Pharmaceutical Research and Manufacturers of America to share information about how the pharmaceutical industry has implemented chemistry, manufacturing, and controls and quality guidances of the International Conference on Harmonization and worldwide regulatory authorities. The AAP process identifies and addresses critical issues in which guidance is lacking, ambiguous, or contradictory. AAPs were designed to provide a forum where one could learn from the experience of experts in pharmaceutical analysis and enhance the understanding of analytical practices that reflect good science and sound regulatory compliance. This article summarizes the discussion points from a meeting regarding the Justification of Specifications topic.

Qualification, Validation, and Verification

April 2, 2007

Pharmaceutical Technology

This article considers the distinction among the terms qualification, validation, and verification in the context of pharmacopeial usage.A recommendation for a standardized usage of the terms validation and verification is provided,and general requirements for validation and verification activities are given.The article also emphasizes the importance of knowing when validation or verification is necessary relative to the use of a method to satisfy pharmacopeial article requirements (for which a monograph exists in the pharmacopeia) or for nonpharmacopeial use.

Process Patent Protection: Characterizing Synthetic Pathways by Stable-Isotopic Measurements

March 2, 2007

Pharmaceutical Technology

The authors describe the methods by which precise analyses of stable-isotopic abundances can be used in security and forensic applications for pharmaceutical materials. These methods include product and process authentication of raw materials, pharmaceutical intermediates, drug substances, formulated drug products, and synthetic pathways. Collectively, these methods can be used to investigate and mitigate patent infringement. In the future, more complete examples will be presented containing full isotopic results and the application of the methods described in this article.

The Impact of Impurity Analysis on Future Regulations

February 2, 2007

Pharmaceutical Technology

As technology for impurity analysis improves, scientists are gaining better information and asking for more regulatory guidance.

The Harmonization of the Microbial Limits Tests

December 2, 2006

Pharmaceutical Technology

The US Pharmacopeia (USP), the Japanese Pharmacopoeia, and the European Pharmacopoeia "Microbial Limits Tests" are in the final stages of harmonization. The harmonized USP chapters are slated for implementation in 2009. This article describes the harmonized USP Chapters <61> "Microbial Enumeration," <62> "Absence of Specified Microorganisms," and <1111> "Microbiological Attributes of Nonsterile Pharmaceutical Products," and suggests they will likely require some revalidation of existing methodologies. Companies should put plans in place immediately for this work and show consistent progress towards this goal.

Adventures in Chromatography

December 2, 2006

Pharmaceutical Technology

We really knew what we were doing—until we opened the column for a routine repacking.

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Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
26%
Attracting a skilled workforce
29%
Obtaining/maintaining adequate financing
14%
Regulatory compliance
31%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
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