Quality Systems

Articles

A new book by Robert Thomas, principal consultant at Scientific Solutions, provides a training tool for novices and inexperienced users of plasma spectrochemistry as well as for supervisors and senior management who want to better understand the analytical issues. Measuring Elemental Impurities in Pharmaceuticals: A Practical Guide, published on Feb.

New Practical Guide Published for Measuring Elemental Impurities in Pharmaceuticals

PharmTech Q&A Series: Measuring Elemental Impurities in Pharmaceuticals with Rob Thomas, Part 1

PharmTech Q&A Series: Measuring Elemental Impurities in Pharmaceuticals with Rob Thomas, Part 2

PharmTech Q&A Series: Measuring Elemental Impurities in Pharmaceuticals with Rob Thomas, Part 3

The company is recalling Pasta De Lassar Andromaco zinc oxide diaper rash treatment after FDA analysis confirmed the product contained high levels of yeast, mold, and bacteria. 

Industria Farmacéutica Andrómaco Recalls Diaper Rash Treatment

Kevin Stembridge is MES Expert at Emerson AutomationSolutions.

Michalle Adkins is Life Sciences Operations Consultant at Emerson Automation Solutions.

Implementing electronic batch records can offer a means of compliance, reduction in errors, streamlined ability to trace actions, and simultaneous generation of documentation.

Making the Move to Electronic Batch Records

Telstar reports that its Boreas, a new 86° ultra-low-temperature freezer, increases average performance by 20%.

New Ultra-Low-Temp Freezer Increases Cold-Storage Performance

The agency sent a warning letter to Malladi Drugs & Pharmaceuticals Limited after an inspection found CGMP violations that included the presence of vermin.

FDA Warns of the Potential of Contamination at API Facility

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

The delivery device and drug form should be considered when choosing a test method for identifying and measuring particulates.

Best Practices for Testing Foreign Particulate Matter in Inhaled Products

Russell E. Madsen is the former senior vice-president of science and technology at PDA, and is a current member of Pharmaceutical Technology's editorial advisory board.

James E. Akers is the president of Akers Kennedy & Associates, PO Box 22562, Kansas City, MO 64113, akainckc@aol.com.

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

A previously published article presented difficulties with the revised European guidelines on sterile manufacturing.  The authors included a brief summary of the comments developed on the draft document.  This article expands upon that summary, outlines the authors' rationale, and highlights the most difficult aspects of the revision draft. 

Quality Assurance/Quality Control