Description
Quality metrics are used throughout the drugs and biologics industry to monitor quality control systems and processes and drive continuous improvement efforts in drug manufacturing. These metrics can also be useful to FDA: to help develop compliance and inspection policies and practices, such as risk-based inspection scheduling of drug manufacturers; to improve the Agency’s ability to predict, and therefore, possibly mitigate, future drug shortages; and to encourage the pharmaceutical industry to implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing. This revised draft guidance includes an explanation of how the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) intend to utilize submitted data and quality metrics to help ensure that their policies and practices continue to support continuous improvement and 26 innovation in the pharmaceutical manufacturing industry
Scope & Applicability
Product Classes
7Products manufactured by establishments in the reporting program
guidance applies to testing of finished drug products
GT products within the scope of this guidance include products that mediate their effect by the expression of transferred genetic materials.; The main subject of the S12 guidance document
CBER regulated manufacturers not focused on in the voluntary phase
limit in active pharmaceutical ingredient (API) or drug product
Primary subject of the GMP guidance; GMP for APIs used in veterinary medicinal products; Subject of the GMP guidance; Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products.
Completed dosage forms subject to lot release and stability testing.; a finished dosage form (FDF) (e.g., tablet, capsule, or solution) that contains at least one active pharmaceutical ingredient; FDF used in product family definitions; Applicable inputs for product report submission
Stakeholders
10Entities expected to submit voluntary data
Establishments involved in primary labeling and secondary packaging
Facilities required to report quality metrics
Manufacturing with oversight responsibilities only
External entity responsible for manufacturing activities
useful to establishments within the pharmaceutical manufacturing industry when selecting component suppliers
Entities eligible to request AMT designation
A restaurant or similar retail food establishment that is part of a chain with 20 or more locations; Entities required to comply with menu labeling final rules.; A restaurant or retail food establishment subject to menu labeling rules.; Entities required to comply with menu labeling regulations.; if you choose to use a menu board in your covered establishment; Entities required to comply with menu labeling requirements.; A restaurant or similar retail food establishment meeting specific criteria
Responsible for ensuring the overall quality of the final drug product.
Covered establishments include contract laboratories.; Entity performing testing only; Entities performing release or stability testing only
Regulatory Context
Attributes
8Indicator of manufacturing process performance.; Metric calculating the proportion of lots started that are released.; Example metric for quality reporting
Example metric for quality reporting
Product attribute for non-application drugs
Specific identified portion of a batch or amount produced in a unit of time
Specific quantity of a drug intended to have uniform character and quality
The degree of uncertainty can impact the critical quality attribute (CQA) risk ranking
Metric measuring the frequency of OOS results attributed to measurement error.
Indicator of patient or customer feedback.; Example metric for quality reporting
Identified Hazards
Hazards
2Future shortages that quality metrics may help mitigate
CARES Act authorities aim to assess, prevent, and mitigate shortages; Risk the Agency efforts to reduce through data visibility
Related CFR Sections (11)
- 21CFR211.198§ 211.198 Complaint files.
(a) Written procedures describing the handling of all written and oral complaints regarding a drug product shall be established and followed. Such procedures shall include provisions for review by the quality control unit, of any complaint involving the possible failure of a drug product to meet anyRead full regulation →
- 21CFR207.35§ 207.35 What changes require a new NDC?
(a) Once an NDC has been assigned by FDA, the registrant must propose a new and unique NDC for a drug when there is a change, after the drug is initially marketed, to any of the information identified in paragraphs (b) and (c) of this section. A new NDC must be proposed to FDA for assignment throughRead full regulation →
- 21CFR211.180§ 211.180 General requirements.
(a) Any production, control, or distribution record that is required to be maintained in compliance with this part and is specifically associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch or, in the case of certain OTC drug products lRead full regulation →
- 21CFR211.160§ 211.160 General requirements.
(a) The establishment of any specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms required by this subpart, including any change in such specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms, shall be drafted Read 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 →
- 21CFR211.165§ 211.165 Testing and release for distribution.
(a) For each batch of drug product, there shall be appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Where sterility and/or pyrogen testing are conducted on sRead full regulation →
- 21CFR211.101§ 211.101 Charge-in of components.
Written production and control procedures shall include the following, which are designed to assure that the drug products produced have the identity, strength, quality, and purity they purport or are represented to possess:Read full regulation →
- 21CFR210.3§ 210.3 Definitions.
(a) The definitions and interpretations contained in section 201 of the act shall be applicable to such terms when used in this part and in parts 211 , 225 , and 226 of this chapter .Read full regulation →
- 21CFR207.1§ 207.1 What definitions and interpretations of terms apply to this part?
The definitions and interpretations of terms in sections 201 and 510 of the Federal Food, Drug, and Cosmetic Act apply to the terms used in this part, if not otherwise defined in this section. The following definitions apply to this part:Read full regulation →
- 21CFR211.22§ 211.22 Responsibilities of quality control unit.
(a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no eRead full regulation →
- 21CFR211.192§ 211.192 Production record review.
All drug product production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. Any unexplained discrepancy (inRead full regulation →
Related Warning Letters (10)
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
SV Labs Corporation
- 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
- 2025-12-02
Compounding Pharmacy/Adulterated Drug Products
PQ Pharmacy, LLC
- 2025-12-02
Compounding Pharmacy/Adulterated Drug Products
Turbare Manufacturing
- 2025-12-02
CGMP/Finished Pharmaceuticals/Adulterated
Rhyz Analytical Labs
- 2025-11-25
Compounding Pharmacy/Adulterated Drug Products
Wells Pharma of Houston, LLC
- 2025-11-25
CGMP/Finished Pharmaceuticals/Adulterated
Owen Biosciences, Inc.
- 2025-11-18
Nonprescription/OTC
DermaRite Industries, LLC
See Also (8)
- Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (Status: Final)
- Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components (Status: Final)
- Collection of Platelets by Automated Methods: Guidance for Industry and FDA Review Staff (Status: Final)
- Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Status: Final)
- Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for Industry (Status: Draft)
- Biological Product Deviation Reporting for Blood and Plasma Establishments: Guidance for Industry (Status: Final)
- Field Alert Report Submission: Questions and Answers Guidance for Industry: Guidance for Industry (Status: Final)
- Inspection of Injectable Products for Visible Particulates: Draft Guidance for Industry (Status: Draft)