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Labcompliance News, January 2004

Jan 19, 2004

New FDA Guidance: Drug Substance - Chemistry, Manufacturing, and Controls Information

Information on the chemistry, manufacturing, and controls (CMC) for the drug substance must be submitted to support the approval of original new drug applications (NDAs), abbreviated new drug applications (ANDAs), new animal drug applications (NADAs), and abbreviated new animal drug applications (ANADAs). This new 66 page guidance is very detailed and provides recommendations on the CMC information for drug substances that should be submitted to support these applications. The guidance is structured to facilitate the preparation of applications submitted in Common Technical Document (CTD) format.

Jan 09, 2004

FDA Starts Pilot Program for Dispute Resolution

The FDA has formally begun the pilot program to dispute 483 observations from GMP inspections. The program started Jan. 1st and will last until December 31. It does not include foreign inspections. The program is based FDA's Draft Guidance for Industry: "Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical GMPs.” The draft guidance explains the process during and after an inspection. .

Jan 09, 2004

FDA Warning Letter for Inadequate Invalidation of OOS HPLC Results

In a recent warning letter the FDA cited a firm for inadequate invalidation of of out of specification results in a QC laboratory. This warning letter has been reviewed by an FDA center and as FDA's David Horowitz, Director of CDER's Office of Compliance, said in a training session is not just the view of a particular investigator of a particular district or even of a particular region. It means that the center has determined that these are significant enough violations that if they are not corrected an enforcement action. The key deviation was: "Out-of-specification (OOS) results were invalidated, without a thorough investigation, supporting data, documentation, or justification." An HPLC OOS result was brought into specification by re-adjusting the baseline, however, the laboratory did not provide a reason for the reintegration. To see the full story and recommendations from Labcompliance and to get access to full warning letter, click here. The warning letter can be downloaded from the Usersclub. Non members can preview excerpts.
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Jan 05, 2004

Validation of Spreadsheet Applications and Macros

Spreadsheet Applications and Macros are considered software and should be validated when used in regulated environment. Frequently users of users of such programs are also programmers and are afraid to go through the big efforts usually associated with software and computer systems validation. However the validation effort should be in line with the complexity and the use of the software. Check the Labcompliance info note to learn how such validation efforts can be simplified and which validation documents are a must.