Explore chapters and articles related to this topic
Regulatory Issues in Granulation
Published in Dilip M. Parikh, Handbook of Pharmaceutical Granulation Technology, 2021
Validation is defined by the FDA as establishing documented evidence, which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes [34]. Process validation is required both in general and specific terms by cGMPs for finished pharmaceuticals – 21 CFR Parts 210 and 211. The WHO defines validation as a collection and evaluation of data, from the process design stage through to commercial production, which establishes scientific evidence that a process is capable of continuously delivering the finished pharmaceutical product meeting its predetermined specifications and quality attributes [35].
Validation
Published in Lorraine Bell, Helping People Overcome Suicidal Thoughts, Urges and Behaviour, 2021
The purpose of validation by clinicians or practitioners is to: increase therapist-client rapport and strengthen the therapeutic alliance;model and strengthen self-validation;facilitate change by using validation as a reinforcer for shaping skilful behaviour in the desired direction of change.
Prevention of Microbial Contamination during Manufacturing
Published in Philip A. Geis, Cosmetic Microbiology, 2020
Equipment cleaning procedures should be validated for the removal of product residues or cleaning agents, but there are several challenges in developing a manufacturing cleaning validation program. These include use of non-dedicated manufacturing equipment, Over-The-Counter (OTC) drug product formulations based upon FDA OTC monographs versus non-OTC product formulations and the number of different product formulations produced in a facility.
Point of care molecular and antigen detection tests for COVID-19: current status and future prospects
Published in Expert Review of Molecular Diagnostics, 2022
William Stokes, Byron M. Berenger, Allison A. Venner, Vincent Deslandes, Julie L. V. Shaw
Verification refers to an evaluation to determine whether claims made by the assay manufacturer can be achieved in a certain laboratory or POCT settings. Validation refers to the evaluation of assay performance whenever deviation is made from manufacturer’s recommendations (e.g. sample type, patient population). For any rapid test, whether molecular or antigen, verification of manufacturer performance claims is important. Larger scale validation studies are also required for use-cases outside those recommended by the manufacturer, such as asymptomatic screening in the case of RATs [80]. Validation studies should be performed in the intended population for the intended use by individuals who will ultimately perform the testing. This will ensure that valid conclusions can be drawn from the study. For longer term studies, it may also be important to consider the changing prevalence of disease over the time of the study [76].
Validation of the International Classification of Functioning, Disability and Health (ICF) core sets from 2001 to 2019 – a scoping review
Published in Disability and Rehabilitation, 2022
Elin Karlsson, Johanna Gustafsson
Quality, in the form of validity, is important for all types of instruments that are intended to be used in both clinical settings and for research purposes. Therefore, when developing and evaluating an instrument, validation is one of the most fundamental issues [5]. There are several kinds of validity, including content, construct and criterion validity. The domain validity can be defined as “the degree to which an outcome measure measures the construct it purports to measure” [6]. Validation can also be described as “the process in which we gather and evaluate the evidence to support the appropriateness, meaningfulness, and usefulness of the decisions and inferences” [7, p.9]. An ICF core set is not an instrument, but it can serve as the foundation for developing instruments for clinical settings and research. Therefore, it is important to ensure that the core set measures and captures what it is supposed to, in other words, that the core set has satisfying validity. To ensure the different aspects of the validity, it is possible to evaluate one or several kinds of validity (e.g., content-construct and criterion validity) and other psychometric aspects, such as reliability and responsiveness [6].
Toxicological analyses: analytical method validation for prevention or diagnosis
Published in Toxicology Mechanisms and Methods, 2021
Lailah Cristina de Carvalho Abrão, Alberto Thalison Silveira, Henrique Dipe de Faria, Simone Caetani Machado, Tássia Venga Mendes, Rodrigo Vicentino Plácido, Luiz Paulo de Aguiar Marciano, Isarita Martins
Method validation is the process used to confirm that the analytical method employed is suitable for its intended purpose, through comparability, traceability and reliability of the results. Different types of validations can be applied depending on the situation. Nonstandard methods, which are still in development and have not been published, require full validation as well as methods developed by the laboratory itself. Cross validation is a comparison of validation parameters between two or more methods assesing if they are capable in generating reliable results, and can be used as a means of determining inter-method equivalency or assessing inter-laboratory execution of the same method. It is applied for standardized methods, methods that have already been published and validated, used for a different scope from which they were previously designed while partial validation may be used in case of extension and modification.