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Labcompliance News, February 2007

February 14, 2007

An Inspector’s Perspective on Computerized Systems Validation

It rarely happens that inspectors from Europe give presentations at public conferences. However this happened at IVT's European Annual Computer System Validation Conference on December 5-7 in Amsterdam with Ludwig Huber as chair person. Malcolm Olver from UK's MHRA gave a presentation with the title: Computer Systems & Software Validation: The expectations and observations of a European Inspector. Mr. Olver explained the audience the regulatory framework presented lists with questions typically asked during inspections. Key point of the observations has been that the Validation Master Plan (VMP) typically is raised too late in the project. He also noted that frequently testing is not related critical functions of the process. Most deviations have been related to inadequate change control, for example, lack of control of software upgrades and no recommendations for revalidation. The full presentation can be downloaded from the Labcompliance Users Club For ordering the UsersClub, click here.

February 14, 2007

"Databases for Data Analysis and other tracking and trending functions not validated", Draws FDA Warning Letter

The Warning Letter was issued based on inspection from December 2006. For example, the letter stated: "Failure to have production and process controls for automated processes, when computers or automated data processing systems are used as part of production or the quality system. A manufacturer is required to validate computer software for its intended use according to an established protocol. For example, databases that are maintained for data analysis and other tracking and trending functions, including complaint and services access databases, have not been validated for their intended use". In addition the company was cited for inadequate identification of training needs, for failure to follow document controls requirements, no or inadequate CAPA procedures, and no validation or verification that implemented CAPA activities are effective. The Warning Letter can be downloaded from the Labcompliance Users Club Non members can preview excerpts.

February 14, 2007

FDA Update on the Drug Quality Reporting System

Since the early 1970s, the FDA has operated the Drug Quality Reporting System (DQRS), which encourages health care professionals to report observed or suspected defects or quality problems with marketed drug products. The program objectives are to rapidly identify significant health hazards, detect industry problems and trends and to operate a centralized reporting system Julitaette Johnson of the FDA has developed a slide presentation with update of the system. The presentation also includes contact information for reporting, a chart with primary defects reported and links to a website with all forms. The presentation can be downloaded from the FDA Website.

February 14, 2007

"Inadequate Equipment Calibration and Record Keeping", Cited in FDA Warning Letter

GxP regulations require that equipment should be suitable for its intended use. The FDA expects that is is demonstrated not only after installation and initial set-up but also during routine use. An example is demonstrated in a warning letter from December 2006 that refers 211.68 (a). The letter states: Failure to routinely calibrate, inspect, or check automatic, mechanical, or electronic equipment according to a written program designed to assure proper performance [21 CFR 211.68(a)]. Specifically, your cryogenic pumping system lacks qualification according to a written plan to assure all parts of the system, including the pump, power supply, electric components, vacuum hold and cryogenic jacket, will operate properly for their intended use every time. The letter listed other deviations: Failure to maintain complete records of the periodic calibration of laboratory instruments, no or inadequate written procedures for production and process control, no or inadequate quality control unit, and failure to perform investigation. The Warning Letter can be downloaded from the Labcompliance Users Club Non members can preview excerpts.

February 14, 2007

Six Sigma Primer for Laboratories

This article written by Cliff Nilsen gives a brief overview on Six Sigma: where it came from, what it is and its approach for laboratories. The justification for such an article is given in the first paragraph. "Now, with FDA placing a greater emphasis on process analytical technology (PAT) and quality systems approach to inspections, the time has surely come for application of Six Sigma to the analytical laboratory". In the article the author emphasizes the importance of six sigma for laboratories: "Six Sigma can play an important role in the correct evaluation of laboratory data for process validation, cleaning validation, blend testing, finished product testing, method validation and evaluation of measurement systems, annual product reviews, product variation and variation among analysts". The article has been published in Pharmaquality and as of January 2007 is available on the publishers website. Copyright rests with the publisher. For other articles from Pharmaquality, click here.

February 14, 2007

New Video Presentation: How to Prepare Your Organization for the 'New' Part 11

In 1997 the United States Food and Drug Administration (FDA) issued a regulation that provides criteria for acceptance by the FDA of electronic records, electronic signatures and handwritten signatures. However, this first release was almost impossible to implement. Therefore the FDA plans to release a new version in 2007. However, the industry is unsure what to do and what the changes will be. Watch the new Labcompliance video with Ludwig Huber to learn what's coming and receive a tool kit with 10+ good practice documents for easy implementation.