If continuous rejection are found in the rejection jar, then what is the handling procedure
Please investigate into the matter to find out source of metal contamination the tablets. Please try to isolate the metal particles from rejected tablets by suspending the tablets in plenty of water to make slurry and physically separate the metal particles. Analyse the metal particles to underatand their physical properties and chemical characteristices. From this information please find out the source of metal particles, whehter coming from APIs, excipients or from your manufacturing equipmet like sieves, mixers, blender, compression machies where there is a friction and force is applied to the powder materials, granules. Once identified the source take appropriate measures to eliminate metal contamination. Establish CAPA actions and follow up for improvement on continuous basis.
Following article will guide you further on this aspect. A link is given here:
Developing a Comprehensive Approach for Preventing Metal Contamination of Pharmaceutical Products
November 1, 2012,
Pharmaceutical Technology, Pharmaceutical Technology-11-01-2012, Volume 2012 Supplement, Issue 6