SOP for Analysis and Release of Finished Product Sample : Pharmaceutical Guidelines

SOP for Analysis and Release of Finished Product Sample

Standard operating procedure of analysis and release of finished product samples in Quality Control.

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 Control

4.0 ACCOUNTABILITY

Manager - Quality Control

5.0 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 Procedure
6.2 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 :____________ 





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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