Quality Control
QUALITY CONTROL
- Sampling of incoming materials as per the laid down specifications and testing of in-process samples, semi-finished, water and products as per IP, BP, USP and in-house specifications.
- Approval for acceptance for raw and packing materials based on test and in process checks during manufacture
- Maintenance of hygiene of personnel and cleanliness of the laboratory and instruments.
- Maintaining written instruction for dealing with complaints concerning the quality of a product and analyzing the cause behind the complaint.
- Participate in validation of product.
- Participate in conduction of validation of cleaning procedure of equipment and machineries.
- Perform calibration of instruments located in QC.
- Monitor the Stability of product throughout its shelf life.
- Maintain written instructions regarding the disposal of rejected materials, whether starting, bulk, packaged or finished products.
- Document the details of operation carried out for reprocessed materials and prevent recurrence.
- Conduct hold time study of bulk granules and bulk tablet
- Conduct training and refresher course for new and old staffs.
- Maintain retain samples of active pharmaceutical ingredient and test these periodically till their expiry dates
- Preserve all documents pertaining to starting materials and finished products for 1 year after the date of expiry of these materials.
Latest News & Updates