Quality Control
The quality control department is having a laboratory which is adequately staffed and
fully equipped for performing all quality control tests and analysis required during and
after manufacturing process. The laboratory is being supervised by a approved qualified
expert staff directly responsible to management but independent of other departments.
The Q.C. department control all raw materials, monitor all in – process quality checks
and control the quality and stability of finished products.
The quality control department is performorming the relative tests for the bulk and
finished product to release or reject each batch of the same.
DISTRIBUTION, COMPLAINTS AND PRODUCT RECALL
Distribution Records :
Distribution records are written data related to distribution of drug product
from the manufacturer to the distributors. These records are maintained in
such a way that complete upto date and progressively recorded data of all
batches of drug products are easily available.
An inventory card is maintained to find out the stock position quickly. A
distribution register is being maintained for detailed information about
distribution of each batch of drug product . Distribution register is having
batch wise details of receipt and issue of the drug products.
Handling of Complaints And Product Recalls :
A written record are maintained for all complaints received. Upon receipt
of complaint Q.C. unit review all the incoming information. If a sample
has been received along with complaint, the sample is examined and tested
. If need be, retained reference sample is examined, tested, analysed. All
the relating data and documentation are reviewed. When investigation is complete, conclusion on the cause and action is being reported to the
management. If it has been found out that the omplaint is the result of
defective production then a copy of complete report is sent to the
production department to take corrective ction. It is the responsibility of
the In-charge, Quality Control to see that each complaint is recorded
evaluated and reported to the management. |
