Providing Lot Release Protocol Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format: Guidance for Industry

Description

We, the Center for Biologics Evaluation and Research (CBER), within the U.S. Food and Drug Administration (FDA, the agency, or we), are issuing this guidance under Title 21 of the Code of Federal Regulations (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, within the Office of Compliance and Biologics Quality (OCBQ).  This guidance updates and supersedes the similarly named guidance, “Guidance for Industry, Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Lot Release Protocols,” dated November 2007 (2007 guidance).  We are updating this guidance to include the submission of electronic lot release protocols through the FDA’s Electronic Submissions Gateway (ESG).

Scope & Applicability

Regulatory Context

• 21CFR10.115§ 10.115 Good guidance practices.

  (a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →

• 21CFR601.14§ 601.14 Regulatory submissions in electronic format.

  (a) General. Electronic format submissions must be in a form that FDA can process, review, and archive. FDA will periodically issue guidance on how to provide the electronic submission (e.g., method of transmission, media, file formats, preparation and organization of files.)Read full regulation →

• 21CFR601.2§ 601.2 Applications for biologics licenses; procedures for filing.

  (a) General. To obtain a biologics license under section 351 of the Public Health Service Act for any biological product, the manufacturer shall submit an application to the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research (see mailing aRead full regulation →

• 21CFR610.2§ 610.2 Requests for samples and protocols; official release.

  (a) Licensed biological products regulated by CBER. Samples of any lot of any licensed product together with the protocols showing results of applicable tests, may at any time be required to be sent to the Director, Center for Biologics Evaluation and Research (see mailing addresses in § 600.2(c) ofRead full regulation →

• 21CFR11.2§ 11.2 Implementation.

  (a) For records required to be maintained but not submitted to the agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part, provided that the requirements of this part are met.Read full regulation →

• 21CFR11.100§ 11.100 General requirements.

  (a) Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else.Read full regulation →

• 21CFR600.2§ 600.2 Mailing addresses.

  (a) Licensed biological products regulated by the Center for Biologics Evaluation and Research (CBER). Unless otherwise stated in paragraph (c) of this section, or as otherwise prescribed by FDA regulation, all submissions to CBER referenced in parts 600 through 680 of this chapter , as applicable, Read full regulation →

• CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

  Fagron Group B.V.

  2022-06-28

• CGMP/Dietary Supplement/Adulterated/Misbranded

  Hawaii Pharm LLC

  2020-05-05

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