1.0.
OBJECTIVE:
Procedure for issuing the certificate of analysis of
the raw materials and batch product.
2.0.
SCOPE:
This Procedure is applicable for preparing and
issuing certificate of analysis at Company.
3.0.
RESPONSIBILITY:
3.1.
QC officer is responsible for preparing
the certificate of analysis for raw material and finished product.
3.2.
QC executive is responsible
for reviewing the certificate of analysis for raw material
3.3.
QC manager is
responsible for reviewing the certificate of analysis of finished product and
approving the certificate of analysis of raw material.
3.4.
QA manager is responsible
for approving the certificate of analysis for finished products.
4.0.
PROCEDURE:
4.1.
Certificate of Analysis shall be issued for each raw material
after release and batch before releasing to the commerce.
4.2.
BMR ,BPR and all analytical Reports shall be reviewed before preparing
the COA.
4.3.
QC officer shall prepare the COA of the Raw material and each
batch of the finished product.
4.4.
COA is issued for the batch number of the product. There shall be
only one COA for the particular batch.
4.5.
Fill all the information of the batch in Annexure
-
I.
4.6.
QC executive/manager shall review the COA for raw material/finished
product, respectively.
4.7.
QC/QA manager shall approve the COA for raw material/finished
product, respectively.
4.8.
Once the COA is approved for raw material, raw materials are ready
for dispensing and transfer all raw materials from “UNDER TEST ZONE” to
“APPROVED ZONE”.
4.9.
The batch shall be released to the commerce once the COA is
approved.
4.10.
Once the batch is shipped, all documents related to the batch
shall be archived in the document control.
5.0.
ANNEXURE:
Annexure - I : Format
of Certificate of Analysis for raw material
Annexure - II : Format of
Certificate of Analysis for finished Product
6.0.
REFERENCES: Nil
7.0.
ABBREVIATION:
|
Sr. No.
|
Abbreviation used
|
Full form of abbreviation used
|
|
1.
|
QA
|
Quality Assurance
|
|
2.
|
QC
|
Quality control
|
|
3.
|
COA
|
Certificate of Analysis
|
|
4.
|
BMR
|
Batch Manufacturing Record
|
|
5.
|
BPR
|
Batch Packing Record
|
8.0.
DISTRIBUTED TO:
Quality Assurance Department,
Quality Control Department,
Manufacturing Department,
9.0.
REVISION HISTORY:
|
Revision No.
|
Change
Control No.
|
Reason
for the Modifications
|
|
|
|
|
Annex -1. Format
of Certificate of Analysis for raw material
|
Company Name
Address
THE DRUG
& COSMETIC ACT.1940 AND THE RULES THERE UNDER
QUALITY CONTROL DEPARTMENT
CERTIFICATE OF ANALYSIS
(RAW MATERIAL)
|
|||||||
|
Material Name
|
:
|
|
A.R.Number
|
:
|
|
||
|
Batch No
|
:
|
|
G.R.Number
|
:
|
|
||
|
Manufactured By
|
:
|
|
Mfg. Date
|
:
|
|
||
|
Supplier’s Name
|
:
|
|
Exp. Date
|
:
|
|
||
|
Purchase Quantity
|
:
|
|
Sample Quantity
|
:
|
|
||
|
Date of Receipt
|
:
|
|
Date of Report
|
:
|
|
||
|
Public Testing Ref No.
|
:
|
|
|||||
|
TEST
|
RESULTS
|
LIMIT
|
|||||
|
|
|||||||
|
CONCLUSION :
|
|||||||
|
Analysis By:
Date:
QC In charge
|
|||||||
Annex -2. Format of
Certificate of Analysis for finished Product
|
Company Name
Address
THE DRUG
& COSMETIC ACT.1940 AND THE RULES THERE UNDER
QUALITY CONTROL DEPARTMENT
CERTIFICATE OF ANALYSIS
(FINISHED PRODUCT)
|
|||||||
|
NAME OF THE MANUFACTURER :
|
|||||||
|
PRODUCT NAME
|
:
|
|
A.R NO.
|
:
|
|
||
|
GENERIC NAME
|
:
|
|
SAMPLE SIZE
|
:
|
|
||
|
BATCH NO.
|
:
|
|
MFG.DATE
|
:
|
|
||
|
BATCH SIZE
|
:
|
|
EXP.DATE
|
:
|
|
||
|
RECEIPT DATE
PUBLIC TESTING REF NO
|
:
:
|
|
REPORT DATE
|
:
|
|
||
|
TEST
|
RESULTS
|
LIMIT
|
|||||
|
|
|
|
|||||
|
|
|
|
|||||
|
|
|
|
|||||
|
|
|
|
|||||
|
|
|
|
|||||
|
CONCLUSION :
|
|||||||
|
Analysis
By:
Date:
QC In charge
|
|||||||
No comments:
Post a Comment