Analysis And Release Of Finished Product Sample

1.0  OBJECTIVE:

To describe the procedure for the Analysis and Release of Finished Product Sample.

2.0  SCOPE:

This SOP is applicable for the Analysis and Release of Finished Product Sample.

3.0  RESPONSIBILITY:

3.1  Officer/Executive-Quality Control.

4.0  ACCOUNTABILITY:

4.1  Manager-Quality Control.

4.2  Head of the Q.C Department.

5.0  PROCEDURE:

5.1  Finished samples should be analyzed as per the procedure under Standard Test Procedure/ Pharmacopoeia standard.

5.2  For other finished product analysis, persons from production dept. should fill the sample intimation request and forward to IPQA for sampling and the sample will be given to Q.C along with sample intimation request.

5.3  After sampling enter the record in Annexure-1.

5.4  Q.C head should assign the work to chemist/ supervisor and inform the results complies/ does not comply with connected production dept. on completion of analysis through Q.A head.

5.5  After completion of testing record the results as per annexure no. 2 & 3 which should be attached with the report of the sample.

6.0  REVISION LOG:

Revision No.

Effective Date

Reason

00

 

New SOP

7.0  REFERENCES:

7.1  Not Applicable.

8.0  ANNEXURES:

Annexure 1: Finished product record.

Annexure 2:Certificate of Analysis.

Annexure 3:Certificate of Analysis.

 

 

Annexure: 1

Finished 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.

Remarks

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Annexure 2:

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

 

 

 

 

 

 

 

 

 

Remarks: The sample complies/ does not comply as per B.P/ U.S.P and in-house specification.

Analyzed by:

 

Checked by:

Approved by:

(Officer Q.C)

(Manager Q.C)

(Manager Q.A)

 

 

 

Annexure 3:

Certificate of Analysis

 

Product:

 

A.R. No.:

 

Batch No.:

 

Sampled on:

 

Mfg. Date:

 

Analyzed on:

 

Exp. Date:

 

Released on:

 

Batch size:

 

Spec. No.:

 

Q.C Sheet no.:

 

Sample qty.:

 

Item/ Product category:

 

Sampler Remarks:

 

Item Product code:

 

Print date:

 

MBR Sheet No.:

 

U.O.M:

 

 

Test

Specification

Results 

 

 

 

 

 

 

 

 

 

Remarks: The sample complies/ does not comply as per B.P/ U.S.P and in-house specification.

Analyzed by:

 

Approved by:

(Officer Q.C)

(Manager Q.A)

Date:

Date:

 


 

 

9.0  ABBREVIATIONS:

Abbreviation

Expanded Form

S

Standard operating procedure

&

And

%

percentage

IPQA

In-process quality assurance

Mfg.

Manufacturing

Exp.

Expiry

A.R. No.

Analytical report number

Spec.

Specification

B.P

British pharmacopoeia

U.S.P

United states pharmacopoeia

MBR

Manufacturing batch record

U.O.M

 

 

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