How to Conduct an Effective Annual Product Quality Review
Duration: 60 Minutes
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.
Objectives of the Presentation
Why Should you Attend
- Discuss how to write APRs
- Outline the requirements for APR reporting
- Review what information to include in the reports
- Discuss how well written APRs benefit your firm's compliance
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. If done properly, the Annual Product Review (APR) report can be a highly valued administrative tool by upper management.
Who will Benefit
- Annual Product Review definitions
- Key benefits or purposes for effective APRs
- What needs to be included in the report
- Records and data
- Approaches for completing APRs
- Decision making based on APRs
- Regulatory expectations for Annual Product Reviews
- A model of an example Annual Product Review Report
- Review of citations
This course is designed for professionals in the Pharmaceutical, Biotechnology and related industries who design, manufacture, organize or otherwise manage drug products and/or active pharmaceutical ingredients (API). It will be especially beneficial to individuals in the following areas:
- QA staff and management
- Compliance Personnel
- Regulatory Affairs
- Quality Assurance
- Product Submission
- Clinical Research
- Documentation and Technical Writing
- Project Management
- Product Development
Annual Product Review (APR) is a critical cGMP requirement. It is an integral part of QA function, which provides an opportunity to assess the state-of-control of the product and process. Annual Product Reviews not only are required by GMP but also can be a robust quality improvement tool if utilized properly.
A 2015 FDA guidance on Quality Metrics places additional emphasis on the Annual Product Review. The FDA will be focusing more on the content of the Annual Product Review and the involvement of senior management in the review and follow-up of the Annual Product Review.