What is reference listed reference and drug standard?

A reference listed drug (RLD) is the listed drug to which the ANDA applicant must show its proposed generic drug is the same with respect to active ingredient(s), dosage form, route of administration, strength, labeling, and conditions of use, among other characteristics.

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What are the official references or compendia that can be used in pharmaceutical products?

Reference standards can be compendial or noncompendial and are typically obtained from the following sources. Compendial (primary): Pharmacopeias such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), or Japanese Pharmacopoeia (JP)

What are FDA guidance documents?

Guidance documents describe FDA’s interpretation of our policy on a regulatory issue (21 CFR 10.115(b)). These documents usually discuss more specific products or issues that relate to the design, production, labeling, promotion, manufacturing, and testing of regulated products.

What is difference between RLD and RS?

The listed drug, approved for safety and effectiveness, identified in the approved suitability petition is the RLD. The drug product approved in the first petitioned ANDA is generally the RS. The applicant should check the Orange Book to confirm the listed drug that the FDA has selected as the RS for that drug product.

What is reference material in pharmaceutical industry?

Reference materials are critical for pharmaceutical manufacturers to ensure safe and effective drug material production. Reference materials are primarily employed in active pharmaceutical ingredient (APIs) quantification, elemental impurity identification, and end-product sterility determination.

What are reference standards USP?

A USP Reference Standard (also known as a physical standard) is a known quantity of a drug substance or ingredient, developed in alignment with the specifications outlined in the USP–NF.

What is the purpose of reference standards?

Reference standards are used to determine quantitative data (such as assay and impurity), qualitative data (such as identification test), and calibration (such as melting point standard). Therefore, the quality and purity of the reference standards are crucial to achieve scientifically valid results.

What is the difference between 21 CFR 210 and 211?

What Does 21 CFR Part 210 And 211 Contain? Part 210 outlines minimum Good Manufacturing Practices (GMP) in manufacturing, processing, packing or holding of all drugs or medicated articles under the purview of the FDA, while Part 211 refers specifically to the GMP requirements of finished pharmaceuticals.

What is a guidance document in healthcare?

Guidance documents are documents prepared for FDA staff, regulated industry, and the public that describe the agency’s interpretation of or policy on a regulatory issue.