Description
The Food and Drug Administration (FDA) is publishing a guidance entitled ‘‘Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products.’’ The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The document provides broad guidance on appropriate standards for the derivation and characterization of cell substrates used in the production of biotechnological/biological products and recommends information in these areas that should be presented in marketing applications.
Scope & Applicability
Product Classes
4Industry subject to GMP and validation requirements
Products for which the presence of live cells cannot be excluded
A type of ATMP involving recombinant nucleic acids or viral vectors.
Covered by GFI #99
Stakeholders
2Responsible for declaring acceptable market names on labels.
Entity responsible for submitting NDINs
Regulatory Context
Attributes
1Measure of the period between thawing MCB and harvesting.
Identified Hazards
Hazards
2Veterinary monitoring to certify absence in source animals
Safety concern regarding viral contamination
Related CFR Sections (4)
- 21CFR314.94§ 314.94 Content and format of an ANDA.
ANDAs are required to be submitted in the form and contain the information required under this section. Three copies of the ANDA are required, an archival copy, a review copy, and a field copy. FDA will maintain guidance documents on the format and content of ANDAs to assist applicants in their prepRead full regulation →
- 21CFR314.81§ 314.81 Other postmarketing reports.
(a) Applicability. Each applicant shall make the reports for each of its approved applications and abbreviated applications required under this section and section 505(k) of the act.Read full regulation →
- 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read full regulation →
- 21CFR314.50§ 314.50 Content and format of an NDA.
NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead full regulation →
Related Warning Letters (5)
- 2025-09-16
False & Misleading Claims/Misbranded
Novo Nordisk Inc.
- 2025-09-16
False & Misleading Claims/Misbranded
Eli Lilly and Company
- 2025-06-10
False & Misleading Claims/Misbranded
Sprout Pharmaceuticals, Inc.
- 2025-05-20
False & Misleading Claims/Misbranded
Sarfez Pharmaceuticals, Inc.
- 2021-02-23
False & Misleading Claims/Misbranded
CooperSurgical, Inc.
See Also (8)
- ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions (Status: Final)
- Guía para la Industria: Pruebas de disolución de formas de dosificación oral sólidas de liberación inmediata. (Status: Final)
- Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products: Guidance for Industry (Status: Final)
- Dissolution Testing of Immediate Release Solid Oral Dosage Forms (Status: Final)
- Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (Status: Draft)
- Labeling OTC Human Drug Products Updating Labeling in RLDs and ANDAs (Status: Final)
- Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products: Draft Guidance for Industry (Status: Draft)
- Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs (Status: Draft)