Analytical method validation and development
Abstract & Details
Research Area
Pharmacy
Keywords
Validation
(CGMP)
(GLP)
Abstract
Validation is one of the key factors to meet current Good Manufacturing Practice (CGMP) and Good Laboratory Practice (GLP) requirements. In any pharmaceutical industry, testing of raw materials, in-process materials, final containers and excipients must be done efficiently. Validation of analytical methods is considered an essential requirement for the testing of such pharmaceutical materials. An analytical procedure should be developed to test the API, excipient and final product. Such a well-designed procedure must essentially ensure that it consistently produces the intended and precise result with high accuracy. To obtain such a specific result, the analytical method must be validated(1).These methods are necessary for many purposes, including quality control release, stability sample testing, comparative test materials and provide information to determine the grant(2).
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Author Information
| # | Name | Institute / Affiliation |
|---|---|---|
| 1 | Kadam Vaibhav N. | Dr. Babasaheb Ambedkar technological University lonare |
| 2 | Bankar Mrunal S. | Dr. Babasaheb Ambedkar technological University lonare |
| 3 | Nimbalkar Krushna B. | Dr. Babasaheb Ambedkar technological University lonare |
| 4 | Andhale Kunal B. | Dr. Babasaheb Ambedkar technological University lonare |
| 5 | Tattu Kalyani B. | Dr. Babasaheb Ambedkar technological University lonare |
| 6 | Nawale Nikhil D. | Dr. Babasaheb Ambedkar technological University lonare |
| 7 | Walunj Nayan G. | Dr. Babasaheb Ambedkar technological University lonare |
| 8 | Kokate Mahesh B. | Dr. Babasaheb Ambedkar technological University lonare |
How to Cite
Use the following formats to cite this article in your research.
APA Style
N., Kadam Vaibhav, S., Bankar Mrunal, B., Nimbalkar Krushna, B., Andhale Kunal, B., Tattu Kalyani, D., Nawale Nikhil, G., Walunj Nayan, & B., Kokate Mahesh (2023). Analytical method validation and development. International Journal of Advance Research and Innovative Ideas In Education, 9(6), 1181-1195.
MLA Style
N., Kadam Vaibhav, et al. "Analytical method validation and development." International Journal of Advance Research and Innovative Ideas In Education, vol. 9, no. 6, 2023, pp. 1181-1195.
IEEE Style
Kadam Vaibhav N., Bankar Mrunal S., Nimbalkar Krushna B., Andhale Kunal B., Tattu Kalyani B., Nawale Nikhil D., Walunj Nayan G., and Kokate Mahesh B., "Analytical method validation and development," International Journal of Advance Research and Innovative Ideas In Education, vol. 9, no. 6, pp. 1181-1195, 2023.
Vancouver Style
N. Kadam Vaibhav, S. Bankar Mrunal, B. Nimbalkar Krushna, B. Andhale Kunal, B. Tattu Kalyani, D. Nawale Nikhil, et al. Analytical method validation and development. International Journal of Advance Research and Innovative Ideas In Education. 2023;9(6):1181-1195.
Harvard Style
N., Kadam Vaibhav, S., Bankar Mrunal, B., Nimbalkar Krushna, B., Andhale Kunal, B., Tattu Kalyani, D., Nawale Nikhil, G., Walunj Nayan, & B., Kokate Mahesh (2023) 'Analytical method validation and development', International Journal of Advance Research and Innovative Ideas In Education, 9(6), pp. 1181-1195.
Chicago Style
N., Kadam Vaibhav, et al. "Analytical method validation and development." International Journal of Advance Research and Innovative Ideas In Education 9, no. 6 (2023): 1181-1195.
Turabian Style
N., Kadam Vaibhav, et al. "Analytical method validation and development." International Journal of Advance Research and Innovative Ideas In Education 9, no. 6 (2023): 1181-1195.
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