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Labcompliance News, November 2003

Nov. 10, 2003

FDA Develops an Agency Wide Quality Systems Guidance

The US FDA is developing an integrated Agency-wide quality systems guidance. Details on the status, objectives, timelines and working groups have been presented at the Japan PDA Annual conference by FDA's James S. Cohen, Associate Director for Compliance and Biologics Quality and Research at CBER. The guidance is expected to be available for public comments by December 1, 2003 and the final release by August 2004.With this the FDA once more follows the Center for Devices and Radiological Health (CDRH) that has a quality system regulation in place since several years. Currently Inspections of medical device companies always cover the quality system and multiple warning letters have been issued (for an example see W-122). In his presentation Mr. Cohen also discussed and presented status and/or further FDA plans, for example: seven steps to speed drug product availability, transfer of therapeutic products from CBER to CDER, international collaborations, science based policies and standards and experience with risk based system inspection approaches (warning letters). The presentation with 62 slides, most of them very detailed, can be downloaded from the LabCompliance Users Club. For ordering the Usersclub, click here

Nov. 8, 2003

Ten New Trend Warning Letters/Inspectional Reports (483's) in the Usersclub Section

Ten FDA Warning Letters/Inspectional reports (483's) have been added to the Labcompliance Users Club section (W-113 to W-122). Some are most recent and all are related to GLP, GCP or cGMP in laboratories or manufacturing. New additions also include a 25 page 483 inspectional observations with 61 citations (w-119). One recent warning letter (W-122) cites deviations related to the quality system, focusing on management responsibilities and corrective and preventive actions (CAPA), clearly a new trend of inspections. W-113 cites missing thorough risk analysis to identify and document any possible hazards. So far missing risk analysis was only cited as a violation of 21 CFR 820, but with the new part 11 guidance stressing the importance of risk assessment we may see this in other areas as well. The FDA has also increased the number of warning letters related to food manufacturing. An example is shown in W-120. There is also an examples from clinical studies (W-118). Warning letters can be downloaded from the Usersclub site. To see extracts and for ordering the Usersclub, click here

Nov 7, 2003

Using Excel™ in Part 11 Environment

Excel is frequently used in regulated environments, for example batch releases in pharmaceutical manufacturing can be based on Excel calculations. Records generated by spreadsheet applications are electronic records and should comply with FDA’s 21 CFR Part 11. On the other hand such spreadsheet programs were not designed for the regulated environment and do not have all the functionality to comply with part 11, for example, there is no part compliant electronic audit trail. Check the Labcompliance info note on how this problem can be solved.

Nov 7, 2003

NIST Released Security Metrics Guide For Information Technology Systems


The final version of NIST Special Publication 800-55, "Security Metrics Guide for Information Technology (IT) Systems" is now available. The document provides guidance on how to establish a metrics program to facilitate decision making and improve performance and accountability through collection, analysis, and reporting of relevant performance-related IT security data.

Nov 6, 2003

Validation Master Plan vs. Master Validation Plan, Validation Project Plan and SOP

Validation activities should follow a documented plan. The question is: should this be master validation plan, a master validation plan, a validation project plan or a just an SOP for validation. Do I need all of them, and if so, what is the difference? What will inspectors ask for? To get answers to these questions, click here.