|
Quality
Control
 |
The
quality control department is part of quality assurance
department . It is headed by a quality control manager.
The major activities of the quality control department
are:
- Approve/Rejection
of raw and packaging materials as per respective
SOPs.
- Testing
of in-process samples as per respective SOPs.
- Testing
of finished goods as per respective SOPs.
- Carrying
out stability studies as per respective SOPs.
- Testing
of water as per respective SOPs.
|
PROCEDURE
FOR RELEASE OF FINISHED PRODUCTS
As
soon as any batch has been finally packed, in the process
Q.A. personal draw random samples of the finished goods.
These random samples are tested against approved specifications
by the Q.C. deptt. These specifications are normally more
stringent than the pharmacopoeial requirements. If the
random samples meet the specifications, the Quality Control
Department certifies that the goods meet the laid down
specifications.
The
batch production record is then reviewed by the Quality
Assurance Manager. He checks for the completeness of the
documents and for the compliance with c-GMPs at various
steps The Q.A. Manager ‘Releases’ the batch for distribution
by signing the BPR.
We
have well equipped quality control lab, which has been
divided into three wings:
1.
CHEMICAL ANALYSIS LAB
2.
INSTRUMENTAL ANALYSIS LAB
3.
MICROBIOLOGICAL ANALYSIS LAB
Besides
quality control we have two different IPQC labs:
1.
IPQC For β-LACTAM
2.
IPQC FOR NON β-LACTAM
|
