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Validation of Analytical Methods and Procedures

Conduct and Document for Efficiency and FDA, USP/EP and ISO 17025 Compliance

Recorded

 

Understanding USP Documents and Reference Standards

General Chapters, General Notices, Monographs, Forum, Reference Standards

Recorded

 

Understanding the New USP <1058> for Analytical instrument Qualification

With SOPs, Templates and Examples for Easy Implementation

Recorded

 

Selection and Use of (Certified) Reference Material

Strategies for  FDA/ISO 17025 Compliance and Tools for Implementation
Recorded

 

NEW BOOK EDITION

Dr. Ludwig Huber

 

 

Labcompliance News, February 2008

New FDA Guidance Regarding the Labeling of Non-Prescription Human Drugs

The Food and Drug Administration (FDA) announced the release of a draft guidance entitled ``Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.'' The guidance is intended to assist industry in complying with the labeling requirements for nonprescription (over-the-counter (OTC)) human drugs marketed without an approved application established by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. The announcement and the guidance is available on FDA's website.

New ISO 17025 Accreditation Package

On February 19, 2008, Labcompliance launched the new ISO 17025 Accreditation Package. The package is a complete solution for laboratories that want to build a modern quality system, for example, according to ISO 17025.. The Package comes with:

  • tools for training, such as an audio seminar
  • tools for developing strategies and policies through an example quality plan
  • tools for implementation and maintenance through SOPs, forms and checklists

The package is ideal for testing and calibration laboratories that plan to get ISO 17025 accreditation. For more information and ordering, click here

New FDA Guidances in 2008

FDA CDER published a list of guidances the agency is planning to develop during
calendar year 2008. Quite interesting will be work on "Standards Recognition" in the Chemistry section.

ILAC Published a Guideline for Providers of Proficiency Testing Schemes

Participating in proficiency testing is recommended by ISO 17025 as one way to assure  the quality of test and calibration results. Such schemes are only useful if they are
performed competently through competent providers. This is what the new ILAC guidelines has been developed for. This document is for providers of proficiency testing schemes who wish to demonstrate their competence by formal compliance with a set of internationally-acceptable requirements for the planning and implementation of proficiency testing schemes. The guidelines can be downloaded from the ILAC website. The Guidelines are based on the technical elements of ISO Guide 43-1:1997 and on the relevant elements of ISO/IEC 17025:2005. To learn everything about ISO 17025 accreditation, click here

New FDA Guidance Regarding the Labeling of Dietary Supplements

The Food and Drug Administration (FDA) announced in the Federal Register of January 2. 2008, the availability of a draft guidance entitled ``Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.'' This draft guidance is intended to assist the dietary supplement industry in complying with the labeling requirements prescribed for dietary supplement manufacturers, packers, and distributors by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA). Separate guidance, issued by the Center for Drug Evaluation and Research on labeling requirements for nonprescription (over-the-counter) human drugs marketed without an approved application, is announced in the Federal Register listed below. The announcement and the guidance is available on FDA's website.

Lack of Method Transfer or Revalidation Protocol Cited in an FDA Warning Letter

The FDA expects analytical methods that are transferred between laboratories to follow a pre-approved transfer protocol. This became obvious in an FDA warning letter. The warning letter stated: "Methods that were validated at one facility and transferred to xxx site are being used without method transfer or revalidation protocol". The FDA also noted that there was no establish scientifically sound and appropriate specifications, standards, sampling plans, and test procedure designed to assure products conform to appropriate standards of identity, strength, quality, and purity. FDA's expectations for method validation, revalidation and method transfer and various options for compliance will be discussed in a new Labcompliance audio seminar that has been recorded and is available with all reference material. The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 187).

Good Manufacturing Practice (GMP) - Volume 4 - Revision of GMP Guidelines to implement concept of Quality Risk Management

As an implementation measure related to the ICH Q9 guideline on quality risk management, the European Commission has reviewed the existing GMP provisions. With the revision of GMP Part I, Chapter 1 on Quality Management quality risk management becomes an integral part of a manufacturer’s quality system. This concept will also be considered in a future revision of GMP Part II. The ICH Q9 guideline as such has been implemented with the new Annex 20. It should be noted that the new Annex is not intended, however, to create any new regulatory expectations; but rather provides an inventory of internationally acknowledged risk management methods and tools together with a list of potential applications at the discretion of manufacturers. For background on the implementation of these revisions please see the revised Introduction.

New Audio Seminars - Schedule for H1/2008

  1. Understanding the New USP <1058> for Analytical Instrument Qualification
    With SOPs and Case Studies for Easy Implementation
    Recorded, available with reference material at any time
  2. Learning from Recent FDA Warning Letters Related to Computer Validation
    and Part 11

    With Clear Recommendations for Corrective and Preventive Actions
    Recorded, available with reference material at any time
  3. Selection and Use of (Certified) Reference Material
    Strategies for  FDA/ISO 17025 Compliance and Tools for Implementation
    Recorded, available with reference material at any time
  4. Sampling and Sample Handling in Laboratories (195)
    Strategies for  FDA and ISO 17025 Compliance and Tools for Implementation
    Recorded, available with reference material at any time
  5. Development and Validation of Stability Indicating Methods (196)
    Planning - Design - Conduct - Documentation
    Recorded, available with reference material at any time
  6. Contingency and Disaster Recovery Planning for Computer Systems (197)
    To Ensure Business Continuity and Compliance
    Recorded, available with reference material at any time

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