Production

Production Operation Chart :

• Necessary requisition note are issued to respective stores duly signed by Approved staff.
• Raw material are dispensed in specific area as per specified in SOP.
• Only “ Approved “ material are issued from the store in presence of technical staff.
• “ Line Clearance “ from Q.C. department before manufacturing activity.
• The bulk products are tested for compliance with the prescribed specification before proceed further.
• On release from Q.C. department filling and packing are done in respective area with In-process checks and controls.
• On final release from Q.C. department the product are released for the dispatch from finished goods store.
• The supervision of approved technical staff, cleanliness of manpower as well as of the area and equipments, precautions against contamination and mix-up etc. are the key parameters which are being followed

Handling of Materials :

All materials are :

• Identified and their containers examined for damage
• Properly stored in quarantine
• Properly sampled by the quality control department in a separate area
• Tested for compliance with requirement and
• Released from quarantine by the Q.C. department by means of written instructions

Starting materials that are accepted or approved are properly and conspicuously labeled as such and is being transferred, to the areas designated for the storage of such materials.

Bulk and finished products are being kept in quarantine till the release from the Q.C. department .

Rejected Materials :

All rejected materials are conspicuously identified as such and
should be destroyed or returned to the suppliers as soon as possible.

General Policy for Process Validation :

Validation of existing product are carried out by reviewing historical data Many of the products have been manufactured by production department successfully for many years. As such these fall within established criteria of finished product release. Since there have not been complaints, recalls or reprocessing of these products, these products have proved themselves with time. In view of this, we simply need to review historical data for such product in order to validate it.

For validation of new process or new product data have to be created by actually performing the process employing same materials and equipments.