comparitive evaluation of annual product quality review with respect to us and europe

Research Article
Khushboo Mayurbhai Vora, Jignesh S. Shah*, and Dilip Girishbhai Maheshwari
Goods manufacturing Practice, Regulations in US, Regulations in Europe, Product Quality Review, Annual Product Review

Annual Product Quality Review (APQR) is basically an evaluation conducted annually to determine if there are any possible changes in the process or manufacturing of the pharmaceutical product or any change in the specifications of the product or any change in the manufacturing process. It is designed to minimize the product defects and also the risks associated with the manufacturing of the pharmaceutical product. This article gives brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe. It also includes the comparative evaluation basically about similarities and differences of requirements associated with the manufacturing of the drug product in these two countries. These will help to minimize the step involved in the manufacturing of the pharmaceutical. It is also necessary to know that the regulatory requirements of different countries are different and hence this will further guarantee the quality of the pharmaceutical product.. Thus the article is based on the comparative evaluation and regulatory requirements for manufacturing of the pharmaceutical product and which will help to maintain the quality of the product.