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The Society for Clinical Data Management (SCDM) [3] has created the Good Clinical Data Management Practices (GCDMP©) standard, [4] a comprehensive document that provides guidance on accepted practices of clinical data management (CDM) that are not totally covered by current guidelines and regulations. This document is updated by Subject Matter ...
Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following:
A predicate rule is any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11. [ 3 ] The rule also applies to submissions made to the FDA in electronic format (e.g., a New Drug Application ) but not to paper submissions by electronic methods (i.e., faxes ).
Process performance qualification protocol is a component of process validation: process qualification.This step is vital in maintaining ongoing production quality by recording and having available for review essential conditions, controls, testing, and expected manufacturing outcome of a production process.
The International Conference on Harmonization (ICH) published a consolidated guidance for industry on Good Clinical Practice in 1996 with the objective of providing a unified standard for the European Union, Japan, and the United States of America to facilitate mutual acceptance of clinical data by the regulatory authorities in those jurisdictions.
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.
This is widely used in the Pharmaceutical, Life Sciences and BioTech industries and is a cousin of Software Testing but with a more formal and documented approach. The validation process begins with validation planning, system requirements definition, testing and verification activities, and validation reporting.
This was soon followed by the FDA's statement of preference for SEND datasets. In December 2014, the FDA CDER and CBER divisions released guidance for industry enforcing the usage of SEND as part of Investigational New Drug (IND) and Biologic License Application (BLA) submission to the US Food and Drug Administration. All studies started after ...