What are the guidelines for CGMP?

The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.

What is the FDA standard that covers the requirements for GMPs?

Current food good manufacturing practices (GMPs) are published in Title 21 of the Code of Federal Regulations, Part 110 (21 CFR 110). GMPs describe the methods, equipment, facilities, and controls for producing processed food.

What is GMP compliance requirements?

GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This protects the consumer from purchasing a product which is not effective or even dangerous. GMP is also sometimes referred to as “cGMP”.

What are CGMP standards?

CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.

What are examples of cGMP?

CGMP is the main regulatory standard for ensuring pharmaceutical quality. This includes over-the-counter and prescription small-molecule drugs and biopharmaceuticals like vaccines, therapeutic blood products, gene therapies, antibodies and cell therapies (e.g. stem cell therapies).

Why are there NO cGMP requirements for combination products?

FDA believes that the absence of clear CGMP requirements for combination products could result in inconsistent or differing application of the various CGMP requirements applicable to the constituent parts, which could affect product safety and the public health.

How are constituent parts of a product subject to cGMP?

Specifically, the constituent parts of a combination product are each subject only to the CGMP regulations applicable to that type of constituent part (e.g., drug or device) if the constituent parts are manufactured and marketed separately, as may be the case for constituent parts of cross-labeled combination products.

What is the purpose of the cGMP rule?

This rule is intended to promote the public health by clarifying which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products.

What are the FDA requirements for combination drugs?

Combination drug/device products as defined by FDA’s 21 CFR part 3 must comply with 21 CFR part 4 subpart A, current Good Manufacturing Practice (GMP) requirements for combination products (see January 2017 Final Guidance, Current Good Manufacturing Practice Requirements for Combination Products ).