QC/QA - Pharmaceutical Technology

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PharmTech Europe

QC/QA

Baxter Recalls Peritoneal Dialysis Solution

August 15, 2014

Baxter voluntarily recalls two lots of peritoneal dialysis solution because of the presence of particulate matter.

Cubist Pharmaceuticals Recalls CUBICIN

August 8, 2014

Cubist Pharmaceuticals voluntarily recalls certain lots of CUBICIN 500 mg in 10 mL single-use vials because of the presence of particulate matter.

Acute Need for Supply Chain Transparency

August 4, 2014

PTSM: Pharmaceutical Technology Sourcing and Management

Biopharma manufacturers must reduce the risk in their complex supply chains

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.

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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
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
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