The Annual Product Review (APR), also known as the Annual Product Quality Review (APQR), is required for marketed products in an FDA-regulated environment. You may ask, “Why would I want to perform an APR?”. The Annual Product Review creates an opportunity to analyze your product’s characteristics, trends, and issues to identify potential process and product improvements.
The purpose of the APR is to generate, review, and provide approval of the report for all products manufactured at the firm where such reviews are required by the regulatory authorities in the intended product markets.
Specifically, the objective of the APR is to provide an evaluation of data and trends to:
- Verify the consistency of the existing product manufacturing process
- Confirm the product consistently meets established specifications and limits
- Identify the need to modify specifications
- Identify significant trends that may negatively impact product quality
- Identify any corrective or preventive actions that would lead to product quality improvements
The key word mentioned above is opportunity. As an unbiased, retrospective evaluation, the Annual Product Review presents an opportunity to create efficiencies and demonstrate that the product remains in a state of control.
Now, you may also ask, “Do I have to perform an APR?”. The short answer is yes. Why? Primarily, it is required by law, by the FDA’s Code of Federal Regulations (CFR).
Key Components of an Annual Product Review
Now that you know you must write the APR; you may be wondering how to get started. What are the primary components that make up the APR?
The key components of the APR include:
- Product records
- Stability data
- Investigation reports (Event Reports, Quality Assurance Reports, and Laboratory Investigation Reports)
- Approved change controls
- Validation reports
- Environmental monitoring data
- Critical utilities/equipment status data
- Analytical (chemical) data and microbiological data
- In-process control data
- Functionality testing data
- Evaluation of reserve sample data
- Drug product complaints
- Product rejections
- Market actions and returned/salvaged products
- Regulatory activity
How about best practices? A few things to review and consider:
- Are my APR authors trained on the APR SOP?
- Are my APR authors fully trained in technical writing in their Subject Matter Expertise?
- Ensure the APR process is reviewed for efficiency, accuracy, and on-time completion.
It sounds like a big task, and it is. To fully understand the APR process, look at your firm’s unique procedure on Annual Product Reviews, and be sure you understand the FDA's CFR requirements.
The Annual Product Review is a fantastic opportunity to learn about your product and its characteristics and identify opportunities for improvement. While it may not be a riveting, thriller-style read, I recommend a read-through of your product’s latest APR report. And, if you’re lucky enough to be part of writing an APR, I say, “congratulations”.
If you need help with your Annual Product Review(s), ProPharma Group is here to assist. We can:
- Aid you with writing your APR
- Review your APR program for efficiency, accuracy, and on-time completion
- Train your APR authors and reviewers on industry best practices and technical writing skills
Remember: The Annual Product Review is not only a great opportunity for improvement, they are required by law. If you have questions or concerns regarding your current APR practices, our compliance experts are here to assist. Contact us today!
