CBER Issues Electronic Lot-Release Protocol Guidance

Published on: 

ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration today posted its final "Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format: Lot Release Protocols."

The US Food and Drug Administration (Rockville, MD, www.fda.gov)posted its final Guidance forIndustry: Providing Regulatory Submissions to the Center for BiologicsEvaluation and Research (CBER) in Electronic Form—Lot ReleaseProtocols. The guidance, which builds on a May 1998 draft, isavailable at www.fda.gov/cber/gdlns/elotrel.htm.

Its purpose is "to provide you with recommendations for submitting lotrelease protocols showing results of applicable tests in an electronicformat, as provided in 21 CFRPart 11.1 By following these recommendations for preparation andsubmission of electronic lot release documents, you might prevent adelay in the product release processing."

The guidance prescribes a submission package that begins with a coverletter in letter in PDF (Adobe portable document format), containing:

  • A description of the submission;

  • A listing of each lot release protocol, with reference to aseparate PDF file with its corresponding filename for each;

  • A statement that the submission is computer-virus free with adescription of the software (name, version, and company) used to checkthe files for viruses;

  • The regulatory and technical point of contact for the submission;

The guidance offers detailed conventions for directory structures,naming the files (using the old DOS convention of an eight-characterfile name plus a three-character extension: FILENAME.EXT), and labelingfloppy disks and CDs.

Model CD Label from CBER Guidance