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Wnp-Qc-Sop-013 Out of Specification (Oos)

This document outlines the procedure for handling out of specification test results at a pharmaceutical company. It describes investigating the cause of any OOS results and taking corrective and preventive actions if needed before making a final decision on a material.

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Muhammad Imran
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18 views4 pages

Wnp-Qc-Sop-013 Out of Specification (Oos)

This document outlines the procedure for handling out of specification test results at a pharmaceutical company. It describes investigating the cause of any OOS results and taking corrective and preventive actions if needed before making a final decision on a material.

Uploaded by

Muhammad Imran
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
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Wenovo Pharmaceuticals

Plot # 31, 32, Punjab Small Industrial Estate , Taxila Pakistan


Document No. Version No. Issue date: Review Date:
WNP/QC/SOP/013 001 01/02/2018 -
QUALITY CONTROL DEPARTMENT
PROCEDURE FOR PROCEDURE FOR OUT OF SPECIFICATION
INVESTIGATION

PROCEDURE FOR OUT OF


SPECIFICATION INVESTIGATION

AMMENDMENT SHEET

REV. # DATE INITIATED BY PAGE # NATURE OF AMENDMENT DONE BY


000 01.01.15 Mr. Salman All New Introduction
001 01.02.17 Ms. Hamyial All Header and Footer added

AUTHORIZED SIGNATORIES
PREPARED BY REVEIWED BY VERIFIED BY
Q.C Analyst Deputy QCM QCM

Page 1/4
Wenovo Pharmaceuticals
Plot # 31, 32, Punjab Small Industrial Estate , Taxila Pakistan
Document No. Version No. Issue date: Review Date:
WNP/QC/SOP/013 001 01/02/2018 -
QUALITY CONTROL DEPARTMENT
PROCEDURE FOR PROCEDURE FOR OUT OF SPECIFICATION
INVESTIGATION

CONTENTS
AMMENDMENT 01

1. PURPOSE…………………………………………...………… 03

2. SCOPE ………………………………………...……………… 03

3. RESPONSIBILITY ……………………………………………… 03

4. ACCOUNTABILITY……………………..……………………… 03

5. PROCEDURE…………………………..…………………… 03

6. RECORDS………………………..……………………… 04

7. DISTRIBUTION…………………………………………..… 04

8. HISTORY……………………. ………………………… 04

Page 2/4
Wenovo Pharmaceuticals
Plot # 31, 32, Punjab Small Industrial Estate , Taxila Pakistan
Document No. Version No. Issue date: Review Date:
WNP/QC/SOP/013 001 01/02/2018 -
QUALITY CONTROL DEPARTMENT
PROCEDURE FOR PROCEDURE FOR OUT OF SPECIFICATION
INVESTIGATION

1. Purpose

The purpose of this Standard Operating Procedure is to describe procedure for handling out of
specification results obtained during analysis.
2. Scope

This standard operating procedure is applicable to the results, which is out of specification obtained
in quality control laboratory for raw material /packaging materials, finished products for releasing
parameters.
3. Responsibility
1. Quality Control Manager
2. Quality Assurance Manager
3. Production Manager
4. Accountability

Quality Assurance Manager


To verify the out of specification results at each and every stage and to give final conclusion about
the status of the material.
5. Procedure:
1. As soon as OOS results obtained, QC Manager will assign another analyst to re-analyze the
sample.
2. If the second Analyst get Ok results, QC Manager will Assign Senior Analyst to re-confirm OK
results.
3. If Senior Analyst reports OK results, training for first Analyst will be conducted this covers
deficiencies of Analyst during Testing.
4. A Training record will be prepared for training activities.
5. However, after confirming OOS results by another Analyst, QC Manager will enter OOS results
in the out of specification log book and immediately inform QA manager and Production
Manger.
6. QA Manger will carry out the investigation to find out root cause of OOS results.
7. After investigation, QA Manager will intimate Production Manager for any corrective action as
well as any necessary preventive action.
8. QA Department will re-sample the material after Corrective Action and forward the same to QCD
for Analysis.
9. If the material meets the requirement, QC will release the material.
10. If the material does not meet the requirement, QC along with Production and QA will take
decision regarding Rejection / Destruction or Return to Supplier of the material.
11. Final conclusion shall be made in the OOS Log Book.

Page 3/4
Wenovo Pharmaceuticals
Plot # 31, 32, Punjab Small Industrial Estate , Taxila Pakistan
Document No. Version No. Issue date: Review Date:
WNP/QC/SOP/013 001 01/02/2018 -
QUALITY CONTROL DEPARTMENT
PROCEDURE FOR PROCEDURE FOR OUT OF SPECIFICATION
INVESTIGATION

6. Records
Description Retention Time
Training SOP 05 Years
OOS Log Book 05 Years
Rejection / Destruction Form 05 Years
 OOS record

7. Distribution List

Copy No. Destination


01 Electronic Copy
02 Master Copy
03 Quality Control Department
04 Quality Assurance Department
05 Production Department

8. History

Revision No. Description


00 New Document

Page 4/4

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