Description
This guidance is intended to assist in applying current good manufacturing practice (CGMP) required under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the manufacture of most investigational new drugs (IND) used in phase 1 clinical trials. These drugs, which include biological drugs, are exempt from complying with 21 CFR part 211 under 21 CFR 210.2(c) (referred to as phase 1 investigational drugs).
Scope & Applicability
Product Classes
8Drugs used in phase 1 clinical trials including biological drugs; Guidance applies to the manufacture of drugs for phase 1 clinical trials.
analytical procedures for biological and biotechnological products may be approached differently
Requires analytical comparability per ICH Q5E
A type of ATMP involving recombinant nucleic acids or viral vectors.
Special manufacturing situation mentioned in TOC; unique manufacturing aspects of investigational cellular therapy products
Drugs used in initial clinical trials to assess safety; new drug or biological drug that is used in phase 1 of a clinical investigation
Preventative or therapeutic vaccines for infectious diseases.
Positron emission tomography drugs
Stakeholders
4Entity responsible for submitting NDINs
Entity responsible for submitting applications under section 524B
Contract acceptor for transportation of APIs
Person qualified to prepare translations
Regulatory Context
Attributes
2Facility must maintain a classification suitable to the operation performed.
intended storage conditions throughout the proposed shelf-life
Identified Hazards
Hazards
2Risk associated with construction, traffic flow, and shared equipment.; Risk from raw food to RTE food or from insanitary objects; Personnel handling RTE foods touch contaminated surfaces
designed to prevent microbial and endotoxin contamination
Related CFR Sections (4)
- 21CFR312.23§ 312.23 IND content and format.
(a) A sponsor who intends to conduct a clinical investigation subject to this part shall submit an “Investigational New Drug Application” (IND) including, in the following order:Read full regulation →
- 21CFR312.57§ 312.57 Recordkeeping and record retention.
(a) A sponsor shall maintain adequate records showing the receipt, shipment, or other disposition of the investigational drug. These records are required to include, as appropriate, the name of the investigator to whom the drug is shipped, and the date, quantity, and batch or code mark of each such Read full regulation →
- 21CFR210.2§ 210.2 Applicability of current good manufacturing practice regulations.
(a) The regulations in this part and in parts 211 , 213 , 225 , and 226 of this chapter as they may pertain to a drug; in parts 600 through 680 of this chapter as they may pertain to a biological product for human use; and in part 1271 of this chapter as they are applicable to a human cell, tissue, Read full regulation →
- 21CFR312.21§ 312.21 Phases of an investigation.
An IND may be submitted for one or more phases of an investigation. The clinical investigation of a previously untested drug is generally divided into three phases. Although in general the phases are conducted sequentially, they may overlap. These three phases of an investigation are a follows:Read full regulation →
Related Warning Letters (10)
- 2025-12-23
In Vivo Bioavailability-Bioequivalence Studies – Clinical
Maria A. Carballosa, M.D.
- 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/Positron Emission Tomography (PET) Drugs/Adulterated
3D Imaging Drug Design and Development LLC
- 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
See Also (8)
- Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products: Guidance for Industry (Status: Final)
- Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs): Guidance for FDA Reviewers and Sponsors (Status: Final)
- Recommendations for Microbial Vectors Used for Gene Therapy: Guidance for Industry (Status: Final)
- Botanical Drug Development: Guidance for Industry (Status: Final)
- Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs): Guidance for Industry (Status: Final)
- Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products Guidance for Industry: Draft Guidance for Industry (Status: Draft)
- Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations, Guidance for Sponsor-Investigators : Draft Guidance for Industry (Status: Draft)
- Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators (Status: Draft)