Each stage of production starting from analysis of incoming materials to the stability of finished products is subjected to critical quality evaluation. Procedures are defined for environmental control as per SOPs.
The internal audit is carried out to ensure cGMP compliance at the site. The audit program is applicable to all sections of the site. Any observations and recommendations made during internal audit are assessed and adjusted for necessary corrective action by the concerned departments.
QA has written program to review the results of in process as well as finished products periodically as per SOP. Similarly the review of stability date is done on regular basis. The final decision regarding any change in process to improve quality, efficacy and safety of the product is jointly taken by QA, Production and Engineering though adequate training to the personnel.