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Labcompliance News, December 2004

December 12, 2004

Audio Seminar: Validation and Use of Excel® Spreadsheets in GLP/GMP and Part 11 Environments now available for instant download.

The on-line session of this seminar was very well attended and because of many questions the seminar has been extended by 20 minutes. However, Labcompliance Newsletter Subscribers had raised concern about the short notice of the seminar in the newsletter. Here is the good news: The seminar with all Q&A's has been recorded and is available on CD and for instant download as high quality MP3 file from the Labcompliance website. This includes all 10+ reference materials, e.g., SOPs, test protocols, checklists, software and validation documents for spreadsheet integrity check and FDA's bulletin on Design and use of Spreadsheets. The feedback from the audience was great. Here are just a few authentic quotes:

Specific examples were provided as well as good recommendations. Most other similar presentations have been very vague about what to do and how to do it.

  • The level of the description was at an understandable level. It was based on user interaction and not on the level of an IT person/ computer support person.
  • The seminar was very informative and all of the documents that could be downloaded were very helpful and informative.
  • I really felt that this was well worth the time and greatly appreciate all of Dr. Huber's time and expertise.
  • Dr. Huber talked about the subject of FDA requirements and/or expectations and validation of spreadsheets and did not sell a specific solution
  • Best and most practical Part 11-related seminar I've attended.

Original e-mails are stored in the Labcompliance Archive. For more information and ordering the recorded version click here.

December 12, 2004

New Guidance on Evaluation of Stability Data

The Food and Drug Administration (FDA) has published a guidance entitled ``Q1E Evaluation of Stability Data.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This guidance is a supplement to an ICH guidance entitled ``Q1A(R2) Stability Testing of New Drug Substances and Products,'' which was revised from Q1A(R) and published in the Federal Register of November 21, 2003 (68 FR 65717).
It is intended to provide guidance on how to use stability data, generated in accordance with the principles outlined in Q1A(R2), to propose a retest period for the drug substance and a shelf life for the drug product. This guidance also describes when and how extrapolation can be considered when proposing a retest period for a drug substance or a shelf life for a drug product that extends beyond the period covered by available data from the stability study under the long-term storage condition (long-term data).

December 12, 2004

New Publication on Stability Testing

One of the constants in our industry is the continuing need to develop information about the stability of active pharmaceutical ingredients and drug products we work with. The need to know the stability of materials that are in development, that are in the clinic and that are being manufactured commercially has resulted in a number of regulatory documents describing the procedures that should be used to generate the required stability information. Efrem Zaret, PhD, president of EZ Associates Inc, has published an article that gives an overview on official guidelines about stability testing. In addition, Dr. Zaret gives recommendations on minimum requirements for a stability data package, product shelf life dating and most important stability tests.

December 12, 2004

FDA Denies Entry of APIs Into the United States due to the Significant GMP

A warning letter from February 2004 stated the FDA will deny entry of drugs manufactured by a company in China into the United States. The inspection from October 2003 revealed significant deviations from U.S. current Good Manufacturing Practice (cGMP) in the manufacture of active pharmaceutical ingredients. Key deficiencies have been: inadequate qualification of QA and QC personnel, missing test data, missing computer files, integrity of test records, inadequate microbiological testing and inadequate storage of reference samples.