Description
The development of complex and highly specialized technology and equipment for the manufacture of biological products has fostered the emergence of many companies that perform only limited aspects of manufacturing processes. Consequently, many manufacturers are interested in sharing or contracting parts of manufacturing in order to facilitate product development and manufacturing flexibility. Cooperative manufacturing arrangements enhance the development of new products.
Scope & Applicability
Product Classes
4Cooperative manufacturing arrangements for licensed biologics; Subject of the cooperative manufacturing arrangements; Subject of the cooperative manufacturing guidance
IVDs requiring UDI on labels
Products intended for further manufacture
Not within the scope of this guidance
Stakeholders
5Entities that may choose to follow this guidance
Non-traditional manufacturer producing devices designed by an OEM
The brand company that holds the license for a covered product.; The brand company holding the approved application or license
Entity holding the biologics license; entity responsible for postapproval obligations
Source of initial product in short supply arrangements
Regulatory Context
Attributes
1Condition allowing use of unlicensed facilities
Identified Hazards
Hazards
1identity and level of any impurities and contaminants
Related CFR Sections (11)
- 21CFR600.14§ 600.14 Reporting of biological product deviations by licensed manufacturers.
(a) Who must report under this section?Read full regulation →
- 21CFR600.3§ 600.3 Definitions.
As used in this subchapter:Read full regulation →
- 21CFR610.13§ 610.13 Purity.
Products shall be free of extraneous material except that which is unavoidable in the manufacturing process described in the approved biologics license application. In addition, products shall be tested as provided in paragraphs (a) and (b) of this section.Read full regulation →
- 21CFR601.22§ 601.22 Products in short supply; initial manufacturing at other than licensed location.
A biologics license issued to a manufacturer and covering all locations of manufacture shall authorize persons other than such manufacturer to conduct at places other than such locations the initial, and partial manufacturing of a product for shipment solely to such manufacturer only to the extent tRead full regulation →
- 21CFR600.12§ 600.12 Records.
(a) Maintenance of records. Records shall be made, concurrently with the performance, of each step in the manufacture and distribution of products, in such a manner that at any time successive steps in the manufacture and distribution of any lot may be traced by an inspector. Such records shall be lRead full regulation →
- 21CFR610.63§ 610.63 Divided manufacturing responsibility to be shown.
If two or more licensed manufacturers participate in the manufacture of a biological product, the name, address, and license number of each must appear on the package label, and on the label of the container if capable of bearing a full label.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 →
- 21CFR601.12§ 601.12 Changes to an approved application.
(a) General.Read full regulation →
- 21CFR610.61§ 610.61 Package label.
The following items shall appear on the label affixed to each package containing a product:Read full regulation →
- 21CFR610.60§ 610.60 Container label.
(a) Full label. The following items shall appear on the label affixed to each container of a product capable of bearing a full label:Read full regulation →
- 21CFR606.121§ 606.121 Container label.
(a) The container label requirements are designed to facilitate the use of a uniform container label for blood and blood components intended for use in transfusion or further manufacture by all blood establishments.Read full regulation →
Related Warning Letters (10)
- 2025-12-23
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded
Darmerica, LLC
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
SV Labs Corporation
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
Guangdong Renhe Guozhuang Biotechnology Co., Ltd.
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
Medinatura New Mexico, Inc.
- 2025-12-16
CGMP/Finished Pharmaceuticals/Adulterated
Sklar Personal Care Inc.
- 2025-12-16
CGMP/Deviations/Biologics License Application (BLA)
Microvascular Tissue, Inc.
- 2025-12-11
CGMP/Finished Pharmaceuticals/Adulterated
Catalent Indiana, LLC
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
DeVere Manufacturing Inc.
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
CDL Services, Inc. DBA Technichem
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
Seaway Pharma Inc.
See Also (8)
- Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments (Status: Final)
- Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203) (Status: Final)
- Shelf Life of Medical Devices (Status: Final)
- Pharmacogenetic Tests and Genetic Tests for Heritable Markers: Guidance for Industry and FDA Staff (Status: Final)
- Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle: Draft Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties (Status: Draft)
- Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and FDA Staff (Status: Draft)
- Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology: Guidance for Industry and Food and Drug Administration Staff (Status: Final)