1.0 OBJECTIVE
To describe the procedure for the Analysis and Release of Finished Product Samples.2.0 SCOPE
This SOP is applicable for the Analysis and Release of Finished Product Samples.3.0 RESPONSIBILITY
Officer/ Executive - Quality Control4.0 ACCOUNTABILITY
Manager - Quality Control5.0 PROCEDURE
5.1 Finished samples from Injectable/ Beta Lactam manufacturing should be analyzed as per the procedure under Standard Test Procedure / Pharmacopoeial standard.5.2 For other finished product analysis, persons from production department should fill the sample intimation request and forward to IPQA for sampling and the sample will be given to Quality Control along with sample intimation request.
5.3 After sampling enter the record in Annexure-I
5.4 QC head should assign the work to chemist/supervisor and inform the results complies / does not comply to concerned production department on completion of analysis through QA head.
5.5 After completion of testing record the results as per annexure number II and III which should be attached with the report of the sample.
6.0 ABBREVIATIONS
6.1 SOP - Standard Operating Procedure6.2 QA - Quality Assurance
6.3 IPQA - Inprocess Quality Assurance
6.4 QC - Quality Control
ANNEXURE -I
FINISH PRODUCT RECORD
Date
|
Name of the Product
|
Batch. No.
|
Batch size
|
Mfg. Date
|
Exp. date
|
Tested on
|
Tested by
|
Raw data sheet No.
|
Released on
|
Released by
|
A R No.
|
Remark
|
ANNEXURE -II
Certificate of Analysis
Product
|
A.R. No.
|
||
Batch No.
|
Sampled On
|
||
Mfg,\. Date
|
Analyzed On
|
||
Exp. Date
|
Released On
|
||
Batch Size
|
Spec. No.
|
Test
|
Specification
|
Observation
|
Remark: The sample complies / does not comply as per IP/BP/USP and In-house specification.
Analysed by : _____________Checked by :_________________ Approved by :_______________
(Officer QC) (Manager QC) (Manager QA)
Date :____________ Date :____________ Date :____________
ANNEXURE –III
CERTIFICATE OF ANALYSIS
Product : A. R. No. :
Batch No. : Sampled On. :
Mfg. Date : Analysis On :
Exp. Date : Released On :
Batch Size : Spec. No. :
QC Sheet No. : Sample Qty :
Item/Product Category : Sampler Remarks :
Item Product Code : Print Date :
MBR Sheet Number : U.O.M : _______________________________________________________________________________
TEST SPECIFICATION RESULTS
_______________________________________________________________________________
_______________________________________________________________________________
Remark: The sample complies / does not comply as per IP/BP/USP and In-house specification.
Analysed by : ______________ Approved by :_______________
(Officer QC) (Manager QC)
Date :____________ Date :____________
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