To run the smooth & quality production and packing of the product.
This procedure applies for whole Production Area.
1. Production Chemist / Supervisor
2. Q.C. Chemist
- 3. Production Manager
The production of individual product is done in strict accordance to the master formula. All the master formula have been developed and authenticated by the required stability studies. Before starting the daily production the following checks are done: Whether all machines are cleaned, Whether the area is cleaned, All the materials required are in hand, ventilation system is functioning properly, SOP’s cum batch card and other formats are ready in hand, All the concerned persons are in uniform Production operation follows the concerned SOP stepwise. For production the SOP and batch-manufacturing card are laid in the same document (so no separate batch card is required).
The SOP cum batch card for individual products is as follows:
|S. No.||Dosage Form||Products||SOP NO.|
For packing the same checks are done as laid in packing has been done as:
- Blister packing
Packing of Individual Products are also written in product wise SOP cum batch card. Individual Machines, which are operational in production department, are marked with M/C NO.
- All the left over powders are removed from the machine after the work of That particular batch is over.
SUBJECT: PROCEDURE FOR PRODUCTION AND PACKING
- These powders etc. constituted a very minute portion of the batch and they are discarded.
- All the machines are cleaned before thoroughly as per individual SOP requirements at end of the day’s work.
- The printed materials are always shredded before discarding them. A register in this effect is maintained.
All the machines are properly positioned and marked by the production department which is having the record in this effect:
|S. No.||Machine Name||Location||M/C No.|
For individual machine operation, cleaning etc. individual sops are available which is describes all the operations in above-mentioned regard for that particular machine. The nos. of those SOP’s is as follows; it is also recorded in a register.
|S. No.||Machine Name||M/C No. (s)||SOP No.|
(Review date on or before 12 months from date of authorization)