USA – Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format : Lot Release Protocols

I. INTRODUCTION

We, the Center for Biologics Evaluation and Research (CBER), are issuing this guidance under 21 CFR 601.14(a) to assist you, manufacturers of biological products regulated by CBER, in submitting lot release protocols in electronic format to CBER’s Product Release Branch. This guidance supersedes the guidance of the same title dated July 2006. We are updating this guidance to delete references to 3.5 inch diskettes due to changes in technology that are phasing out the use of this type of electronic format.

FDA’s guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe the FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

II. DISCUSSION

In accordance with section 610.2 (a) in Title 21 of the Code of Federal Regulations (CFR),
CBER may require you to submit, for CBER review and confirmatory testing, samples of any lot of any licensed product, together with the protocols showing results of applicable tests.
Regulatory submissions in electronic formats, consistent with lot release requirements applicable to your product, will facilitate our review of your submission, provided that you submit your data to us in an electronic format that we can readily access. Pursuant to 21 CFR 11.2(b)(2), FDA has identified such submissions in public Docket No. 92S-0251 as being the type of submission the agency accepts in electronic form (e.g., compact disk-read only memory (CD-ROM) or other formats that may become available in the future). This guidance is intended to provide you with recommendations for submitting lot release protocols showing results of applicable tests in an electronic format, as provided in 21 CFR Part 11.1 By following these recommendations for preparation and submission of electronic lot release documents, you might prevent a delay in the product release processing…