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The USP is published in a combined volume with the National Formulary (a formulary) as the USP-NF. [2] If a drug ingredient or drug product has an applicable USP quality standard (in the form of a USP-NF monograph), it must conform in order to use the designation "USP" or "NF".
Test coverage in the test plan states what requirements will be verified during what stages of the product life. Test coverage is derived from design specifications and other requirements, such as safety standards or regulatory codes, where each requirement or specification of the design ideally will have one or more corresponding means of verification.
Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.
21 C.F.R. 211.110 (a)(6) states that bioburden in-process testing must be conducted pursuant to written procedures during the manufacturing process of drug products. [3] The United States Pharmacopeia (USP) outlines several tests that can be done to quantitatively determine the bioburden of non-sterile drug products.
A TPS report ("test procedure specification") is a document used by a quality assurance group or individual, particularly in software engineering, that describes the testing procedures and the testing process.
There are three typical situations where dissolution testing plays a vital role: (i) formulation and optimization decisions: during product development, for products where dissolution performance is a critical quality attribute, both the product formulation and the manufacturing process are optimized based on achieving specific dissolution targets.
Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA).
USP grade meets the purity levels set by the United States Pharmacopeia (USP). USP grade is equivalent to the ACS grade for many drugs. NF grade is a purity grade set by the National Formulary (NF). NF grade is equivalent to the ACS grade for many drugs. British Pharmacopoeia: Meets or exceeds requirements set by the British Pharmacopoeia (BP ...