Questions and Answers on Current Good Manufacturing Practices for Drugs | Guideline Explorer

Description

As part of the Current Good Manufacturing Practices (CGMP) initiative announced in August of 2002, and to help FDA be more transparent with CGMP policy, we have developed this question and answer resource on current good manufacturing practices. We intend to use this format to provide timely answers to questions about the meaning and application of CGMPs for human, animal, and biological drugs, and to share these widely. These questions and answers clarify statements of existing requirements or policy that are minor in nature, and as such, are considered Level 2 guidance. You may submit comments on this guidance at any time. Submit comments to Docket No.FDA-2017-D-6821(see the instructions for submitting comments in the docket). This resource is being cosponsored by CDER, CVM, CBER, and ORA. The Q&As generally clarify the existing CGMP regulations for finished pharmaceuticals:21 CFR part 211

Scope & Applicability

Product Classes

6

Reference Listed Drug

The drug product identified by the applicant for comparison; Comparison of ANDA product to RLD for pH adjuster differences

Solid Oral Dosage Forms

Subject of the minor changes guidance

Generic Solid Oral Dosage Forms

Size and Shape of Generic Solid Oral Dosage Forms

RLD

Reference Listed Drug used as the basis for an ANDA submission.

Ophthalmic drug product

Generic ophthalmic drug products and their cap colors

Combination Product

Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.

Stakeholders

3

Generic Drug Manufacturer

Entity submitting correspondence; Entities eligible to submit controlled correspondence.; Entity that may submit requests for clarification.

FDA designated reference standard

Standard used when RLD is discontinued.

Reference listed drug

The RLD used as a comparator for generic drug scoring and size.

Regulatory Context

Attributes

2

Dose Proportional

active and inactive ingredients are in the same proportion between the different strengths

Cap color

Physical property of ophthalmic drug packaging

Related CFR Sections (2)

21CFR211.166§ 211.166 Stability testing.
(a) There shall be a written testing program designed to assess the stability characteristics of drug products. The results of such stability testing shall be used in determining appropriate storage conditions and expiration dates. The written program shall be followed and shall include:Read full regulation →
21CFR211.170§ 211.170 Reserve samples.
(a) An appropriately identified reserve sample that is representative of each lot in each shipment of each active ingredient shall be retained. The reserve sample consists of at least twice the quantity necessary for all tests required to determine whether the active ingredient meets its establishedRead full regulation →

Related Warning Letters (2)

CGMP/Finished Pharmaceuticals/Adulterated
Huangshi Hygienic Material Medicine Co., Ltd.
2025-06-03
CGMP/Finished Pharmaceuticals/Adulterated
Cosmobeauti Laboratories & Manufacturing Inc.
2023-08-29