(1999; 168 pages) [Spanish]
5.3 Rejected and recovered materials
Any starting material, intermediate or finished excipient not complying with specifications must be clearly identified and segregated to prevent inadvertent use or release for sale. A record of non-compliance should be maintained. All cases of non-compliance should be investigated to identify the root cause.
These materials may be:
- reprocessed/reworked to meet the specified requirements;
- regraded for alternative applications; or
- rejected or scrapped.
Occasional reprocessing/reworking of an excipient may be acceptable. However, relying on the final testing only of the reprocessed excipient to demonstrate compliance to specification is not acceptable. The quality of the reprocessed material must be evaluated and documented showing adequate investigation and demonstrating that the reprocessed excipient is at least equivalent to other acceptable excipients. When reprocessing has to be done frequently, it may be an indication that the process, work instruction or training is inadequate and needs to be adjusted or reinforced.