A Brief Review on Pharmaceutical Validation
| Autor: | Darshan A. Salade, Kishor S. Arote, P. H. Patil, Vikas V. Patil, Amol R. Pawar |
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| Rok vydání: | 2022 |
| Zdroj: | Asian Journal of Pharmaceutical Analysis. :211-217 |
| ISSN: | 2231-5675 2231-5667 |
| DOI: | 10.52711/2231-5675.2022.00035 |
| Popis: | Validation is the procedure which authorizing documentary evidence that proves the following process will consistently produce the product which leads to the expected result. According to GMP validation studies are important part of GMP these are required to be done as per predefined protocols, the minimum that should be validated include process, testing and cleaning as a result such control procedure stablish to monitor the output and validation of manufacturing processes that may be responsible for variability of drug product. Validation is the one of the important part in achieving and maintaining the quality of the final product. The validation study provides the accuracy, sensitivity, specificity and reproducibility of the test methods employed by the firms, shall be established and documented. Process validation is the process for improving the safety and quality of the dosage form which is manufactured in the pharmaceutical industry. Process validation is an integral part of quality assurance as per cGMP. Validation and quality assurance will go hand in hand, ensuring the thorough quality for product. Process validation plays a key role in the pharmaceutical manufacturing process as it delivers a high degree of assurance and evidence that the process, which is being carried out gives out the uniform results, that is, it means the required specifications, which has been performed accurately. The purpose of this review is to present an introduction and general review on validation in pharmaceutical industry. |
| Databáze: | OpenAIRE |
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