Annual Product Quality Review (APR) is 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 webinar will give a 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 will also discuss the comparative evaluation about similarities and differences of requirements associated with the manufacturing of the drug product in different countries. 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.
- Annual Product Review Overview
- How to write APRs
- What needs to be included in the report
- Outline the requirements for APR reporting
- Review what information to include in the reports
- A model of an example Annual Product Review Report
- Discuss how well written APRs benefit your firm’s compliance
- Quality Assurance Teams
- Compliance Teams
- Regulatory Affairs Teams