QA/QC

Apr 02, 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.
Apr 02, 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.
Mar 02, 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.
Feb 02, 2007
Pharmaceutical Technology
By Pharmaceutical Technology Editors
As technology for impurity analysis improves, scientists are gaining better information and asking for more regulatory guidance.
Dec 02, 2006
Pharmaceutical Technology
By Pharmaceutical Technology Editors
We really knew what we were doing—until we opened the column for a routine repacking.
Dec 02, 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.
Nov 30, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
London (Nov. 22)-The European Medicines Agency reports a defect in some vials of Herceptin (trastuzumab), the anticancer treatment by Roche, which have been distributed in Europe. As a result, The EMEA's Committee for Medicinal Products for Human Use outlined a plan, formulated in conjunction with Roche, for the visually reinspecting and replacing defective vials.
Nov 16, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Mystic, CT (Oct. 26)-Kenneth G. Chapman died at his home here on Oct. 26. He was 79. The cause was pancreatic cancer
Nov 16, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Over-the-counter drug maker Perrigo Company issued a voluntary recall of certain lots of store-brand acetaminophen 500-mg caplets that could contain trace amounts of metal particulate. Approximately 11 million bottles of acetaminophen are affected by the recall.
Nov 09, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
AAPS, San Antonio (Oct. 31)-Industry and regulatory agency concerns over process variability have prompted both groups to take a closer look at analytical method transfer processes.
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