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Metro Pharmaceuticals (Pvt.)Ltd.
Department
Document No.
Quality Control
MP/ QCD/MSOP/005
Standard Operating Procedures
Effective Date
Next Revision Date
01-09-2018
01-09-2020
Swab Test
Revision Date
Revision No.
24-08-2018
01
Prepared by: Sign with Date
Reviewed by: Sign with Date
Approved by: Sign with Date
Microbiologist
Quality Control Manager
Quality Assurance
Manager/QMR
Controlled Copy: Do not Duplicate Copy# Page 1 of 2
1.0 Purpose:
The SOP provides procedure for the monitoring of non sterile Area using swab technique.
2.0 Scope:
It is applicable to all over the factory.
3.0 Responsibility:
a. Quality Control Manager
Responsible for ensuring of proper implementation of SOP.
b. Microbiologist
Responsible for follow up of this SOP.
4.0 Description:
1. Take the required material into the desired location for the testing.
2. Unsealed the swabs.
3. Loosen the screw cap of test tube containing sterile NaCl/phosphate buffer pH
7.2/peptone water placed in test tube.
4. Wet the swab in one of the above mentioned solution.
5. Swab an area of 2.5x2.5 inch
2
on the desired place.
6. Put the swab back in the same test tube containing the solution. And label it.
7. Completing the test, incubate all the test tube at 30 35
o
C and also streak the swab on
the labeled plates.
8. Note the result after 24 hrs 48 hrs of incubation.
5.0 Records
Document No.
Description
Retention Time
Showing Page:
2/2
Metro Pharmaceuticals (Pvt.)Ltd.
Department
Document No.
Quality Control
MP/ QCD/MSOP/005
Standard Operating Procedures
Effective Date
Next Revision Date
01-09-2018
01-09-2020
Swab Test
Revision Date
Revision No.
24-08-2018
01
Prepared by: Sign with Date
Reviewed by: Sign with Date
Approved by: Sign with Date
Microbiologist
Quality Control Manager
Quality Assurance
Manager/QMR
Controlled Copy: Do not Duplicate Copy# Page 2 of 2
6.0 Distribution List
Copy No.
Destination
Issued To
01
Electronic Copy
QMD
02
Master Copy
QMD
03
Quality Control Department
7.0 History
Revision No.
Description
00
New Document

Unformatted Attachment Preview

Metro Pharmaceuticals (Pvt.)Ltd. Standard Operating Procedures Microbiologist 1.0 Quality Control Effective Date 01-09-2018 Revision Date Swab Test Prepared by: Sign with Date Department 24-08-2018 Reviewed by: Sign with Date Approved by: Sign with Date Quality Control Manager Quality Assurance Manager/QMR Document No. MP/ QCD/MSOP/005 Next Revision Date 01-09-2020 Revision No. 01 Authorized by: Sign with Date Plant Manager Purpose: The SOP provides procedure for the monitoring of non sterile Area using swab technique. 2.0 Scope: It is applicable to all over the factory. 3.0 Responsibility: a. Quality Control Manager Responsible for ensuring of proper implementation of SOP. b. 4.0 Description: 1. 2. 3. 4. 5. 6. 7. 8. 5.0 Microbiologist Responsible for follow up of this SOP. Take the required material into the desired location for the testing. Unsealed the swabs. Loosen the screw cap of test tube containing sterile NaCl/phosphate buffer pH 7.2/peptone water placed in test tube. Wet the swab in one of the above mentioned solution. Swab an area of 2.5x2.5 inch2 on the desired place. Put the swab back in the same test tube containing the solution. And label it. Completing the test, incubate all the test tube at 30 – 35oC and also streak the swab on the labeled plates. Note the result after 24 hrs – 48 hrs of incubation. Records Document No. Description Controlled Copy: Do not Duplicate Retention Time Copy# Page 1 of 2 Metro Pharmaceuticals (Pvt.)Ltd. Standard Operating Procedures Reviewed by: Sign with Date Microbiologist 6.0 Effective Date 01-09-2018 24-08-2018 Approved by: Sign with Date Quality Assurance Manager/QMR Quality Control Manager Document No. MP/ QCD/MSOP/005 Next Revision Date 01-09-2020 Revision No. 01 Authorized by: Sign with Date Plant Manager Distribution List Copy No. 01 02 03 7.0 Quality Control Revision Date Swab Test Prepared by: Sign with Date Department Destination Electronic Copy Master Copy Quality Control Department Issued To QMD QMD History Revision No. 00 Description New Document Controlled Copy: Do not Duplicate Copy# Page 2 of 2 Name: Description: ...
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