What is CFR in GMP?
Title 21 of the CFR or the Code of Federal Regulations deals with governing of food and drugs in the United States for three of its governing bodies: The FDA (Food and Drug Administration), DEA (Drug Enforcement Agency) and ONDCP (Office of National Drug Control Policy). …
Is a joint assay of the active substances in a combination product acceptable?
‘Is a joint assay of the active substances in a combination product acceptable? ‘ Yes, a joint assay would be acceptable if satisfactorily justified in line with the herbal quality guidelines (EMEA/HMPC/CHMP/CVMP/214869/06, CPMP/QWP/2820/00 Rev 1, CPMP/QWP/2819/00 Rev 1).
What is constituent part of combination?
Combination products consist of any combination of a drug, a device, and a biological product. Each drug, device, and biologic product included in a combination product is referred to as a “constituent part” of the combination product.
What is the purpose of 21 CFR Part 11?
WHAT IS 21 CFR PART 11? 21 CFR Part 11 is the FDA’s regulations for electronic documentation and electronic signatures. It outlines the administration of electronic records in a medical device company’s quality management system.
What are some examples of combination products?
Examples of combination products include prefilled syringes, pen injectors, auto-injectors, inhalers, transdermal pumps and patches, and kits containing drug administration devices or components (see Fig.
What is FDA combination rule?
(a) Two or more drugs may be combined in a single dosage form when each component makes a contribution to the claimed effects and the dosage of each component (amount, frequency, duration) is such that the combination is safe and effective for a significant patient population requiring such concurrent therapy as …
Which activity is governed by the FD&C Act of 1938?
The Federal Food, Drug, and Cosmetic Act of 1938 (APA) is a federal law passed in 1938. The law established quality standards for food, drugs, medical devices, and cosmetics manufactured and sold in the United States.