As per the Federal Code of Regulations, 21 CFR 211.180(e), product reviews are to be conducted at least once annually to determine the need for changes in drug product specifications or manufacturing or control procedures. This is an important GMP practice and a critical component of an FDA 483 audit.
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Templates and checklists to help facilitate your review
During an FDA inspection, we find that companies consistently receive observations for failure to have a comprehensive annual review process. Observations similar to below are commonplace:
…..Written procedures are not followed for evaluations done at least annually and including provisions for a review of investigations conducted for each drug product.
Specifically, the firm did not capture all elements in their annual product review as specified in SOP ….., “Annual Product Review.”
Annual reviews are more than just compiling data and trending parameters, such as yield, cycle time, and summarizing change controls. In recent inspection observations curated by GMP Trends, we see an FDA 483 audit also addresses critical dimensions in related systems such as stability, laboratory controls, analytical methods, customer complaints, and employee training.
FDA inspections commonly begin with a request to see the annual review. In recent inspections, this has even been conducted on a virtual basis with the FDA requesting annual review information to be sent electronically before the physical site visit. For this reason, the annual review for each product should be easily transmittable in electronic form.
The annual product review should begin with a justification of how much data is included in the review. In certain circumstances, it will be important to use more than just the trailing twelve months of data. This is especially the case with infrequently produced products where the number of batches produced does not constitute a large sample size.
Your firm should consider the annual review to be the showcase for all manufacturing quality systems. It is often the first impression the FDA will receive of your company.
Download our FREE Annual Product Review Checklist to avoid the mistakes made by other companies. Commit to quality with GMP Trends and be ready for your next FDA inspection.
