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Labcompliance News, December 2006

December 15, 2006

New ICH Draft Guidance to Facilitate Regulatory Acceptance of Analytical Procedure

The ICH Q6A Guideline encourages the development of harmonized texts by the Pharmacopoeial Discussion Group (PDG). However, until now, ICH has not really addressed the regulatory acceptability of pharmacopoeial-proposed pharmacopoeial analytical procedures and/or acceptance criteria (APAC) for the three ICH regions. An Expert Working Group has been formed to address this issue. As a result the ICH published the Draft Guideline Q4B titled "Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC)". This document describes a procedure to facilitate acceptance by regulatory authorities of pharmacopoeial analytical procedures and/or acceptance criteria (APAC) for use in the three ICH regions. According to the guide implementation details will be described in the topic-specific annexes which will be available on the ICH website.

December 15, 2006

FDA Asks for Input on Electronic Submission of Regulatory Information

The Food and Drug Administration (FDA) announced plans to hold a public hearing to solicit comments and information on the electronic submission of product information. The Agency is also interested in hearing the public's perspectives on issues related to creating an electronic information exchange platform. Information provided at the hearing will help FDA shape a modern paperless submission process and help facilitate the effective use of submitted information, including drug safety information.

December 15, 2006

FDA Uses Excel® Spreadsheets in Its Own Laboratories

Some companies don't want to use Excel® and other spreadsheets in FDA regulated environments. Concerns are that such spreadsheets are not accepted by the FDA. However, FDA professionals made it clear that Excel can be used in FDA regulated environments if specific procedures and technical controls are implemented. As a matter of fact FDA is using Excel® in its own laboratories to comply with their own regulations. The FDA has developed two internal Information Bulletins that guide single and multiple users of spreadsheets through the process. Controls include: User ID/Password for secure log-on, MS NTFS to limit access to files, storage of spreadsheets on write protected server directories, validation of spreadsheet applications, control and archive of spreadsheets for internal audits, standardizing design of templates (use of colors, cell protection). To learn more about using Excel® in FDA regulated environments and to receive 10+ good practices documents for easy implementation, click here.

December 15, 2006

"Equipment not Routinely Calibrated, Inspected, and Checked for Accuracy" Draws FDA Warning Letter

The Warning Letter was issued based on conditions found during an inspection conducted between August 8 and August 14, 2006. The FDA wrote as one of 14 deviations: "Failure to establish, implement, and control procedures to ensure that equipment used in production and measuring are routinely calibrated, inspected, and checked for accuracy Specifically, no records are maintained for the inspection, checking, adjustment and calibration of scales, production furnace, and filling machine". In addition to problems equipment calibration, the firm failed to ensure complaint files are maintained and that all oral and written complaints are documented upon receipt and are processed in a uniform and timely manner. Furthermore the company failed to establish, implement, and control procedures for Corrective Action and Preventive Action (CAPA). The Warning Letter can be downloaded from the Labcompliance Users Club. Non members can preview excerpts.


December 15, 2006

PIC/S Releases Draft Guidance on GMPs for Pharmacies and Hospitals

The Pharmaceutical Inspection Cooperation / Scheme released a new draft guide: "Good Practices for Preparation of Medicinal Products in Pharmacies". The purpose is to provide guidance on Good Manufacturing Practice (GMP) for medicinal products for human use prepared in small scale facilities, such as hospital or other pharmacies. The basic requirements presented in this Guide are valid for all medicinal products, non-sterile and sterile, prepared extemporaneously or for stock, which do not have a marketing authorization. The draft Guide is released for consultation to the relevant associations (i.e. representing hospital and other pharmacies) in PIC/S countries. The deadline for comments is 30 March 2007.

December 15, 2006

New Article: Using GS/MS in FDA Regulated Environment

Gas Chromatography combined Mass-Spectrometry is a useful tool to quality and quantify volatile compounds in pharmaceutical development and manufacturing. The most important application is the determination of regulated residual solvents in raw material, packaging material and drugs. For operation in FDA and other regulated environments the system must have the functionality to comply with FDA regulations such as GLP, CGMP and 21 CFR Part 11. A new article describes one specific application and functionality of an GC/MS system that is required to comply with FDA and other regulations and guidelines.