What does the term "rework" mean in a GMP context?

In a GMP context, the term "rework" refers to the process of reprocessing a product that does not meet specifications. This can occur when a product has been identified as non-conforming, meaning it does not satisfy the established quality standards or specifications for its intended use. The rework process aims to correct the deficiencies in the product so that it can meet the quality requirements and be released for sale or further processing.

Reworking is a critical aspect of quality assurance in pharmaceutical manufacturing, as it enables companies to salvage products that might otherwise be discarded, thus minimizing waste and ensuring that resources are utilized effectively. However, it is essential that rework is carried out following strict protocols and documented evidence to ensure compliance with GMP regulations and maintain the integrity of the product.

This definition encompasses the importance of quality control and the management of products at all stages of manufacturing, ensuring that products are safe and effective for consumers.