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Labcompliance News, March 2003

March 12, 2003

FDA Publishes Concept Paper On Premarketing Risk Assessment

FDA's CDER/CBER Risk Assessment Working Group is drafting a guidance for industry on good risk assessment practices during drug and biological product development. This new concept paper is intended to facilitate public discussion on the content of the draft guidance by outlining FDA's proposed approach and requesting comment. Specifically, the concept paper presents FDA's preliminary thoughts on:
Important risk assessment concepts
Generation and acquisition of safety data during product development
Analysis and presentation of safety data in an application for approval

March 10, 2003

Inadequate Training Frequently Cited Deviations in Warning Letters

Training is a key requirement of all FDA regulations and quality standards like ISO17025. For example cGMP 21 CFR 211.25 states: "Each person engaged in the manufacture, processing, .. of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions." Inadequate training, missing training plans and documentation are amongst the most frequently cited deviations. For examples see extracts of warning letters/483's:
The center director had not received any training on this computers system even though he retains a high security level for data entered on this computer system (W-103)
Employee training on the use of the new [redacted] computer system, which is used in donor screening and product processing, was not-complete. (W-103)
There are no records to document that the Information Technology (IT) service provider staff personnel have received training that include current good manufacturing practice regulations (W-101)
Your firm fails to have sufficient personnel with the necessary training to assure that all activities required by ... are correctly performed (W-100)
Training needs not established, training not documented (W-065).

In response to this, Labcompliance has developed a package consisting of an SOP and a slide presentation. The material should help to develop, establish and document a training program and results. The package is specifically designed for users of computer systems and networks in part 11 environments but can also be used as model for other regulated environments. The package can be downloaded from the Users Club (G-008 and G-009). For preview and ordering the Usersclub, click here.

March 9, 2003

All FDA Warning Letters Reviewed by Centers

Starting March 1st FDA plans to review all warning letters by relevant Centers. This will help identify possible program inconsistencies and resolve them before warning letters are issued and to analyze deviations. Regular analysis of these data will aid the Centers in identifying trends used to further develop a risk-based strategy towards cGMP enforcement practices. FDA can also use this knowledge to enhance policy, provide guidance, and establish training for the FDA field staff and regulated industry.
This was announced on FDA's website in Q&A session on the Pharmaceutical cGMPs for the 21st Century. For more info on the new initiative and it's impact on 21 CFR Part 11, click here.

March 9, 2003

FDA's Progress Report of the 483 Communications Working Group

As part of FDA's Pharmaceutical cGMPs for the 21st Century a 483 Communications Working Group was formed and asked to determine the proper mechanism for communicating deficiencies to industry. The group prepared prepared the following language to be provided to the sponsor with the 483 to clarify the purpose and effect of the 483 and alert the recipient about how to object to an observation or how to bring new information to FDA's attention: "This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance. If you have an objection regarding an observation, or have implemented, or plan to implement, corrective action in response to an observation, you may discuss the objection or action with the FDA representative(s) during the inspection or submit this information to FDA at the address above. If you have any questions, please contact FDA at the phone number and address above."

March 9, 2003

New FDA Guidance for Stability Testing

The FDA has released a new 11 page guidance on "Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products". This guidance is intended to address recommendations on the application of bracketing and matrixing to stability studies conducted in accordance with principles outlined in the ICH guidance Q1A(R) Stability Testing of New Drug Substances and Products (the parent guidance). The parent guidance notes that the use of matrixing and bracketing can be applied, if justified, to the testing of new drug substances and products, but provides no further guidance on the subject. In this new guidance specific principles are defined for situations in which bracketing or matrixing can be applied. Sample designs are provided for illustrative purposes and should not be considered the only, or the most appropriate, designs in all cases.

March 9, 2003

New FDA Draft Guidance for Drug Chemistry, Manufacturing, and Controls Information

This 60 page draft guidance provides recommendations on the chemistry, manufacturing, and controls (CMC) information for drug products that should be submitted in original new drug applications (NDAs) and abbreviated new drug applications (ANDAs). The guidance is structured to facilitate the preparation of applications submitted in Common Technical Document (CTD) format (see section II.A and B).