Labcompliance News, May 2007

May 26, 2007

FDA Perspective on Risk Based Validation of Computer Systems

George Smith, Consumer Safety Officer at CDER, US FDA, and member of FDA's Part 11 task force gave an excellent presentation at the IVT conference Computer System Validation in Arlington on April 24. More than 120 delegates listened to the presentation entitled: How to Take a Risk-based Approach to Computer Validation in an FDA Regulated Environment.". Main topics of the presentation have been: Why a risk based approach and how we arrived where we are, understanding what's coming to proceed with validation efforts, choosing which system to validate and appropriate levels of validation based on predicate rules. At the end Mr. Smith also gave an update on the status of the new Part 11 regulation. Labcompliance Usersclub members can download the presentation. For preview and ordering, click here. To learn more about Risk Based Computer Validation, click here. To learn more about the 'New' Part 11, click here.

May 26, 2007

Final FDA Guidance on 'Using Computerized Systems in Clinical Investigations' Released

The document supersedes the guidance of the same name dated April 1999. The content is significantly different from the previous guidance. It reflects FDA's new approach towards computer systems and electronic records and it is expected to have a high impact on all FDA regulated areas, not only on clinical trials. Therefore all Pharmaceutical, Biopharmaceutical and Medical Device industries are advised to study the guidance and get a good understanding on FDA's approach for validation of computerized systems. In a new audio seminar attendees not only learn about the scope and content of the guidance but even more importantly about FDA's new approach on how to deal with computer systems. The guidance can be downloaded from the FDA website.

May 26, 2007

Falsified Data Generated in Tests of Drugs Led to Bankruptcy of a Generic Drug Manufacturer

A former Vice President in charge of the Quality Control Department and three supervisory chemists at a now-defunct generic drug manufacturer pleaded guilty to a conspiracy involving the rampant falsification and manipulation of testing data of drugs. The fraud had been documented in an FDA 483 Inspectional Observation from May 2005. For example the 483 states: "Samples of drug products were routinely resampled, and re-injected or reprocessed during testing in the QC Laboratory when out of specification (OOS) results were obtained", "The Quality Unit failed to review electronic data as part of batch release, review computer audit trails in the data acquisition system and provide adequate training to analytical chemists", and "OOS results were substituted with passing results by analysts and supervisors. The substitution of data was performed by cutting and pasting of chromatograms, substituting vials, changing sample weights and changing processing methods". After the testing problems were disclosed, the company's share price dropped nearly 75% in one day, from $24 to $6.36. A few months later, the company filed for bankruptcy. It later was liquidated. "The damage from the fraud was devastatingly complete," Christopher Christie, the U.S. Attorney for New Jersey, said in a statement. "Consumers were put at risk, a company that employed 500 people was destroyed, and shareholders were left with nothing in the end." Complete information is available at the website for The United States Attorney’s Office – District of New Jersey. The 483 Observations can be downloaded from the Labcompliance Users Club. Non members can preview excerpts.

May 26, 2007

Free Video Webcast: How USP Chapter <1058> on Analytical Instrument Qualification Will Effect You

Analytical instrument qualification is the foundation for method validation, calibration, system suitability and other quality control checks. The overall goal is valid analytical measurement! The USP has developed a draft chapter for analytical instrument qualification (AIQ) that firmly places AIQ as a required quality control process. It is well known that FDA inspectors require firms to follow USP standards and procedures. Therefore pharmaceutical companies in the US and elsewhere are advised to prepare - before the standard becomes effective. When implemented right the standard also helps to reduce overall qualification costs. Therefore there is lots of interest in learning about the new standard. Ludwig Huber, editor of Labcompliance, and Surendra Bansal, Research Director Non Clinical Drug Safety, Hoffmann-La Roche, Inc, will present a free video web about scope, content and status of the chapter. Click here to learn more about it and to register

May 26, 2007

FDA Compliance Update: Data Integrity and Fraud - Another Looming Crisis?

Edwin Rivera, Chief Investigations and Preapproval Compliance Branch at CDER US FDA gave a compliance update for CDER at the 31st international GMP conference in Athens, Georgia. He started the presentation with a brief overview on the objectives of the pre-approval inspection program and the roles of reviewers and CDER’s Office of Compliance. Then he focused his entire presentation on one of FDA's recent concern: integrity of electronic data. He told the audience the had planned to give a more general update, but based on recent inspection findings and other events he changed the focus of the presentation just on this topic. For example, three of ten recent audits revealed data of highly questionable reliability that are currently under review by CDER and second audit assignments are to be issued shortly. He also gave a lot of examples. For example, the FDA found unreliable data in applicant submissions where initial out of specification results where brought into specifications through intentional computer manipulation of chromatograms. Mr. Rivera finished the presentation with FDA's plans on how to respond to this: 1) Specialized training of investigational staff on uncovering data integrity, data manipulation and fraud, 2) PAIs to focus more on data integrity and fraud and 3) Through the agency's commitment to follow-up on leads or information regarding data manipulation and fraud. He also gave recommendations to the industry: 1) Train employees on proper handling handling and reporting of data and 2) To assure the reliability of data reported in applications and manufacturing records. The full presentation can be downloaded from the Labcompliance Users Club. For ordering the Usersclub, click here. To learn more about FDA compliant handling of electronic data, click here.

May 26, 2007

Joint GMP Auditing Program for the Europe Economic Area (EEA)

The audit program as published by EMEA forms an essential part of the quality system adopted by GMP inspectorates. It aims to ensure consistency of GMP standards and a harmonized approach throughout Europe. The enlarged European Economic Area (EEA) with around 40 GMP inspectorates emphasizes the need for a consistent approach. Joint audits are expected to lead to an improvement of the assessed authorities and allow the possibility that national auditors can transfer experiences gained during the audits to their national inspectorates. Mutual confidence among European inspectors is therefore established and maintained through these joint visits. Possible exposure of weaknesses and deficiencies allows the authorities to improve their quality system.