Current Issue : October-December Volume : 2021 Issue Number : 4 Articles : 2 Articles
In accordance with the public health the quality standards are to be maintained, so as to meet the requirements of customer, as they are the priority that is to be maintained. So far there has been so many recalls that were found in this pandemic period as the treatment as given with different types medications. They were mainly recalled because as they didn’t satisfy the safety and quality reasons. Here are some of the different ways or methods for reducing the product recalls. To reduce the risk for product recall certain measures can be implemented such as strategies for an effective recall, block chain, retroactive analysis, health hazard evaluation, annual product review which includes cGMP (current good manufacturing practices) requirements with CAPA (corrective actions and preventive actions) and risk management program. Products are recalled for safety or quality reasons to the quality standards for customer protection and satisfaction. It is the responsibility of the manufacturing companies to meet the standards for a good product by following the quality standards which reduces the risk so; this may be considered as the most challenging development in coming generations....
A new, rapid, economical and isocratic reverse phase high performance liquid chromatography (RP-HPLC) method was developed for the estimation of related substances in altretamine bulk drug. Altretamine is an antineoplastic agent used in palliative treatment of persistent or recurrent ovarian cancer. The chromatographic method was optimized using the samples generated from forced degradation studies and the impurity spiked solution. Good resolution between the process related impurities and degradation products from the analyte was achieved on Zorbax SB-C18 column using the mobile phase consists a mixture of 10 mM ammonium carbonate in water pH adjusted to 8.0 with ammonium hydroxide solution and Methanol in the ratio of 35:65 v/v at detection of 227 nm wavelength. The limit of detection and the limit of quantitation for altretamine and its process related impurities were established. The stressed test solutions were assayed against the qualified standard of Altretamine and the mass balance in each case was in between 98.7%-99.8% indicating that the developed liquid chromatography method was stability-indicating. Validation of the developed LC method was carried out as per International Council for Harmonization requirements. The developed method was found to be suitable to check the quality of bulk samples of altretamine during its storage and stability studies....
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