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The EPA's Good Laboratory Practice Standards (GLPS) compliance monitoring program guarantees the accuracy and reliability of test data submitted to the Agency to support pesticide product registration under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), section 5 of the Toxic Substances Control Act (TSCA), and in accordance ...
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.
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".
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.
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).
Software Validation: The process of evaluating software during or at the end of the development process to determine whether it satisfies specified requirements. [IEEE-STD-610] Software Verification: The process of evaluating software to determine whether the products of a given development phase satisfy the conditions imposed at the start of ...
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.
USP 800 (Hazardous Drugs—Handling in Healthcare Settings) is a guideline created by the United States Pharmacopeia Convention (USP), as one of their General Chapters through which the USP "sets quality standards for medicines, dietary supplements and food ingredients".