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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: Equipment validation
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.
For instance, a regulatory agency (such as CE or FDA) may ensure that a product has been validated for general use before approval. An individual laboratory that introduces such an approved medical device may then not need to perform their own validation, but generally still need to perform verification to ensure that the device works correctly ...
of the drug product, including its established, proprietary, code, and chemical names; the dosage form and strength; the route of administration; the identification numbers of all investigational new drug applications that are referenced in the application; the CFR Code of Federal Regulations Title 21
ISPE has published a series of good practice guides for the industry on several topics involved in drug manufacturing. The most well-known is The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture. The second edition (GAMP5) was released in July 2022. [2]
Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have published guidelines relating to process validation. [ 1 ]
Manufacturing processes must be controlled, and any changes to the process must be evaluated. Changes that affect the quality of the drug are validated [9] as necessary. Instructions and procedures must be written in clear and unambiguous language using good documentation practices. Operators must be trained to carry out and document procedures.
Verification and validation (also abbreviated as V&V) are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. [1] These are critical components of a quality management system such as ISO 9000. The words "verification" and ...