{"title":"分析方法开发与验证综述","authors":"Vishakha Shingote, S. Mankar, S. B. Dighe","doi":"10.52711/2349-2988.2022.00012","DOIUrl":null,"url":null,"abstract":"Any pharmaceutical industry's primary goal is to consistently produce products with the required characteristics and quality at a reasonable cost. A method must be developed for the discovery, development, and evaluation of medicines in pharmaceutical formulations. The primary goal of this review paper was to examine the creation and validation of the medicine formulation technique from the beginning. applies to the entire commercial batch of the product. When an analytical approach is used to obtain results for the quality of medicine-related samples, it is critical that the results are accurate. A validation policy is specified in the pharmaceutical industry for how to execute validation, types of validation, and validation policies to meet the requirements of good manufacturing practise (GMP) laws. Validation is critical to the efficient operation of pharmaceutical companies. Stability and validation were undertaken at every stage, from raw material to completed product. The method was appropriately established, and validation parameters were discussed using the example of various substances in terms of accuracy, specificity, precision, limit of detection (LOD), limit of quantitation (LOQ), ruggedness, robustness, and system suitability testing. For the routine and stability analyses, all validation parameters are utilised.","PeriodicalId":20915,"journal":{"name":"Research Journal of Science and Technology","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2022-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"2","resultStr":"{\"title\":\"A Review Article on Analytical Methods Development and Validation\",\"authors\":\"Vishakha Shingote, S. Mankar, S. B. Dighe\",\"doi\":\"10.52711/2349-2988.2022.00012\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Any pharmaceutical industry's primary goal is to consistently produce products with the required characteristics and quality at a reasonable cost. A method must be developed for the discovery, development, and evaluation of medicines in pharmaceutical formulations. The primary goal of this review paper was to examine the creation and validation of the medicine formulation technique from the beginning. applies to the entire commercial batch of the product. When an analytical approach is used to obtain results for the quality of medicine-related samples, it is critical that the results are accurate. A validation policy is specified in the pharmaceutical industry for how to execute validation, types of validation, and validation policies to meet the requirements of good manufacturing practise (GMP) laws. Validation is critical to the efficient operation of pharmaceutical companies. Stability and validation were undertaken at every stage, from raw material to completed product. The method was appropriately established, and validation parameters were discussed using the example of various substances in terms of accuracy, specificity, precision, limit of detection (LOD), limit of quantitation (LOQ), ruggedness, robustness, and system suitability testing. For the routine and stability analyses, all validation parameters are utilised.\",\"PeriodicalId\":20915,\"journal\":{\"name\":\"Research Journal of Science and Technology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2022-03-06\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"2\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Research Journal of Science and Technology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.52711/2349-2988.2022.00012\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Research Journal of Science and Technology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.52711/2349-2988.2022.00012","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
A Review Article on Analytical Methods Development and Validation
Any pharmaceutical industry's primary goal is to consistently produce products with the required characteristics and quality at a reasonable cost. A method must be developed for the discovery, development, and evaluation of medicines in pharmaceutical formulations. The primary goal of this review paper was to examine the creation and validation of the medicine formulation technique from the beginning. applies to the entire commercial batch of the product. When an analytical approach is used to obtain results for the quality of medicine-related samples, it is critical that the results are accurate. A validation policy is specified in the pharmaceutical industry for how to execute validation, types of validation, and validation policies to meet the requirements of good manufacturing practise (GMP) laws. Validation is critical to the efficient operation of pharmaceutical companies. Stability and validation were undertaken at every stage, from raw material to completed product. The method was appropriately established, and validation parameters were discussed using the example of various substances in terms of accuracy, specificity, precision, limit of detection (LOD), limit of quantitation (LOQ), ruggedness, robustness, and system suitability testing. For the routine and stability analyses, all validation parameters are utilised.