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Labcompliance News, July 2005

July 5, 2005

New ISPE/GAMP Guide Good Practice Guide for Laboratory Systems Released

ISPE has published a New Good Practice Guide: Validation of Laboratory Systems. While the GAMP Guide for Validation of Automated Systems (GAMP 4) is recognized as industry standard for computer validation is not detailed enough for specific applications, for example for laboratories. On the other hand because of their criticality laboratory computers are right on target of FDA inspections. The guide is expected to be the single most important reference for automated laboratory systems from stand alone automated systems to complex networked systems and the FDA and EU Agencies are using GAMP Guidance as reference for the industry. Categories two to five in GAMP 4 have been expanded to seven categories recognized the need for more resolution for laboratory systems. When implemented right the guide can help to reduce workload for validation, for example through risk based validation. For example, the guide suggest to reduce testing for 'identical systems used in the same manner'. The Good Practices Guide can be Ordered from the ISPE Website, To help a good understanding on the guide Labcompliance offers an Audio Seminar with 10+ reference documents for easy implementation.

July 5, 2005

New FDA Guidance: Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients.

This document provides guidance concerning development of safety profiles to support use of new excipients as components of drug or biological products. It is intended for use by reviewers within both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) and by interested individuals in industry. It is also intended to foster and expedite the development of new excipients, communicate to pharmaceutical and excipient manufacturers current CDER and CBER recommendations on the nonclinical safety data that should be generated to support excipient development, and increase uniformity within CDER and CBER as to expectations for the nonclinical safety evaluation of excipients.

July 5, 2005

Three New Articles: Supplier Audits, QA/QC Stability testing and Quality Control Laboratories

The first publication focuses on reducing costs of supplier audits without reducing quality. The focus of the second article is on the criticality of proper planning, execution and managing stability studies for understanding data generated during clinical trials. The 3rd publication written by Dr. Efrem Zaret, president of EZ Associates Inc (ef@ezassociates.com) starts with a list of deviations typically found during FDA inspections of QC laboratories and gives recommendation on how to avoid deviations.

July 5, 2005

No Risk Assessment for Change Control of Software Draws FDA Warning Letter

In April the FDA cited one more firm for no formal risk analysis during design and changes of software. "For example, a formal risk analysis of the original system design and software changes to correct software bugs that caused incorrect functionality or performance problems, and to enhance the product, has not been documented", The letter continues: "Although your software release notes briefly describe the nature of unresolved software bugs in a particular software version, they do not explain the impact of these software bugs on user needs and intended uses". Furthermore, the letter noted; "Installation is not in conformance with the Current Good Manufacturing Practice (CGMP) requirements", and "Your firm was not able to explain what changes had been made to the device design validation document (e.g., Commissioning Validation Plan) when the document version was changed from v0.91 to v0.96; Testing to release software version 2.008 contains unclear explanation of the software validation test results to document what exact functionality or performance problems were detected during testing and to explain the impact of these problems. For example, your firm's device installation procedure was in the draft form at the time of our inspection, and your firm has not maintained records of installation activities and inspection results". The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. To learn about risk based validation of computer systems and other part 11 requirements, click here.