QC/QA - Pharmaceutical Technology

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QC/QA

One Step Back, Two Steps Forward to Improved Quality Processes

May 8, 2014

Life-sciences companies can get a jump on potential quality problems by looking at the leading indicators hiding in the document management process further upstream.

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.

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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
31%
Breakthrough designations
8%
Protecting the supply chain
42%
Expedited reviews of drug submissions
8%
More stakeholder involvement
12%
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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