Standard Operating Procedure

Title: SOP for SOP

Site: SOP No.: Version No.: Effective date : Review Period

Name and Designation Signature Date

Prepared by:

Checked by:

Approved by:

Authorized by:
 1.0 OBJECTIVE:
To lay down a procedure for preparation, approval and authorization, Control and Revision of
standard operating procedure.

2.0 SCOPE:
This SOP describes the basic principle, defines the responsibilities, and lay down the procedure of
preparation of SOPs. This SOP is applicable to all SOPs.

3.0 RESPONSIBILITIES:
3.1 Preparation and Execution: Officer and above
3.2 Approval: Manager and above.
3.3 Authorization: Plant Head

4.0 ACCOUNTABILITY:
Head of the Concerned Department
5.4 PROCEDURE:
5.1 Prepare the SOP on approved A4 Size paper.
5.2 Prepare the SOPs to describe operating procedure and steps.
5.3 Write the SOPs in clear and unambiguous language, easy to understand and easy to follow.
5.4 Write the SOPs under the following sub-heading:
1.0 OBJECTIVE
2.0 SCOPE
3.0 RESPONSIBILITIES
4.0 ACCOUNTABILLITY
5.0 PRECUDURE
6.0 REFERANCE
7.0 ANNEXURE
8.0 ABBREVATION

5.4.1 OBJECTIVE:
Write the reason for preparation of SOP in one sentence or maximum two sentences starting with the
latter “To”.

Prepared by Checked By Approved by

Name and
Designation
Date
 5.4.2 SCOPE:
This section defines the applicability of the SOP, also specifies the department, areas or sections to
which this SOP shall be applicable.

5.4.3 RESPONSIBILITIES:
Write the designation of the person/persons who are directly responsible for the operation maintion in
the objective of the SOP

5.4.4 ACCOUNTABILITY:
Write the Head of concern department who is accountable for the SOP.
5.4.5 PROCEDURE:
5.4.5.1 Write the Procedure/ Methods in Short Sentence. Do not write Instruction in long paragraphs.
5.4.5.2 Mention all the checks to be carried out, records to be determined, frequency of various operations,
Check, and special precaution, if any.
5.4.5.3

Prepared by Checked By Approved by

Name and
Designation
Date
 Prepared by Checked By Approved by
Name and
Designation
Date
- Prepared by Checked by Approved by
Name and
Designation
Date
6.1.2 AREA-WISE GOWNING PROCEDURE

A) Gowning procedure: Entry into Class E area from outside the building
1) All employees shall change into clean slippers, remove their personal slippers and place
them in designated shoe rack.
2) Personal garments shall be removed and clean dress for class E shall be put on.
3) Clean dress for class E comprises of .................(brief description)
B) Gowning procedure: Entry into Class D area from Class E area.
1) Slippers used in class E shall be taken off and placed on designated rack meant for class D.
Fresh slippers allocated for the class D area shall be worn. Shoe cover shall be worn on
freshly changed slippers.
2) Clean dress worn in Class E shall be removed and clean dress designated for class D shall be
put on.
3) Clean dress for class D comprises of full sleeve tee shirt and cotton trouser .
4) A white lab coat shall be worn over the clean dress and a white cap shall be worn over the
head.
C) Gowning procedure: Entry into Class C area from Class D area
1) Lab coat and cap used in class D area shall be taken off and stored in locker.
2) Shoe cover used in class D area shall be discarded into the designated bin.
3) Complete set of coverall shall be worn over inner dress used in class D area.
4) Head gear and mask of coverall shall be worn first. Strings on the mask shall be tied in a
secure manner to the back of the head. Head gear shall be worn on the mask.
5) After wearing headgear, the bodysuit shall be worn. The bodysuit shall be worn by putting
the legs in first followed by the hands. The zipper shall then be pulled up and the buttons
shall be fastened such that the bodysuit covers the flap of the headgear resting on the
shoulders.
6) Gloves shall then be worn and sprayed with 70% isopropyl alcohol.
D) Gowning procedure: Entry into Class B area from Class C area
1) The Gloves worn in class C shall be taken off and discarded in the designated bin.
2) The coverall worn in Class C shall be taken off. The bodysuit shall be unzipped and taken
off first.

- Prepared by Checked by Approved by

Name and
Designation
Date
 3) After taking off the bodysuit, the headgear shall be taken off and discarded in the designated
area for autoclaving.
4) The mask shall be taken off at last and discarded for autoclaving in the designated container.
5) The coverall designated for class B area shall then be put on.
6) Head gear and mask of coverall shall be worn first. Strings on the mask shall be tied in a
secure manner to the back of the head. Head gear shall be worn after wearing the mask.
7) After wearing headgear, the bodysuit shall be worn. The bodysuit shall be worn by putting
the legs in first followed by the hands. The zipper shall then be pulled up and the buttons
shall be fastened such that the bodysuit covers the flap of the headgear resting on the
shoulders.
8) The foot cover shall then worn over the part of the bodysuit covering the feet and shall be
zipped and tied securely.
9) Gloves shall then be worn and sprayed with 70% isopropyl alcohol.

6.2 VISITORS :
6.2.1 GENERAL RULES
1. All the visitors entering the factory building, beyond the office blocks, shall always be
accompanied with key personnel of the company.
2. Visitors also must wear the clothing and the shoe covers provided, while entering the
plant.

6.2.1 AREA-WISE GOWNING PROCEDURE

A) Gowning procedure: Entry into Class E area from outside the building
1) Visitors shall change into clean slippers and keep personal shoes on the designated shoe
rack.
2) Visitors shall not have to change clothing while entering class E area.
B) Gowning procedure: Entry into Class D area from Class E area.
1) Visitors shall take off slippers used in Class E and then shall put on slippers designated for
Class
2) Visitors shall put on clean lab coat and clean cap.
C) Gowning procedure: Entry into Class C area from Class D area
- Prepared by Checked by Approved by
Name and
Designation
Date
 1) Lab coat and cap used in class D area shall be taken off and stored in locker.
2) Shoe cover used in class D area shall be discarded into the designated bin.
3) Complete set of coverall shall be worn on inner dress put on in class D area.
4) Head gear and mask of coverall shall be worn first. Strings on the mask shall be tied in a
secure manner to the back of the head. Head gear shall be worn on the mask.
5) After wearing headgear, the bodysuit shall be worn. The bodysuit shall be worn by
putting the legs in first followed by the hands. The zipper shall then be pulled up and the
buttons shall be fastened such that the bodysuit covers the flap of the headgear resting on
the shoulders.
6) Gloves shall then be worn and sprayed with 70% isopropyl alcohol.
7) Gowning procedure: Entry into Class B area from Class C area
1) The Gloves worn in class C shall be taken off and discarded in the designated bin.
2) The coverall worn in Class C shall be taken off. The bodysuit shall be unzipped and
taken off first.
3) After taking off the bodysuit, the headgear shall be taken off and discarded in the
designated area for autoclaving.
4) The mask shall be taken off at last and discarded for autoclaving in the designated
container.

5) The coverall designated for class B area shall then be put on.
6) Head gear and mask of coverall shall be worn first. Strings on the mask shall be tied in a
secure manner to the back of the head. Head gear shall be worn after wearing the mask.
7) After wearing headgear, the bodysuit shall be worn. The bodysuit shall be worn by
putting the legs in first followed by the hands. The zipper shall then be pulled up and the
buttons shall be fastened such that the bodysuit covers the flap of the headgear resting on
the shoulders.
8) The foot cover shall then worn over the part of the bodysuit covering the feet and shall be
zipped and tied securely.
9) Gloves shall then be worn and sprayed with 70% isopropyl alcohol.

- Prepared by Checked by Approved by

Name and
Designation
Date
 6.3 DETAILS OF THE GOWNING MATERIALS
Type of gowning Category of Details (material and
material personnel color)
Lab Coat Visitors
Employees : Officers
Employees : Workmen
Employees : Maintenance
Employees : QC/QA

Cap Visitors
Employees : Officers
Employees : Workmen
Employees : Maintenance
Employees : QC/QA

Class C area coverall Visitors

Employees : Officers
Employees : Workmen
Employees : Maintenance
Employees : QC/QA

Class C area gloves Visitors

Employees : Officers
Employees : Workmen
Employees : Maintenance
Employees : QC/QA

Class B area coverall Visitors

Employees : Officers
- Prepared by Checked by Approved by
Name and
Designation
Date
 Employees : Workmen
Employees : Maintenance
Employees : QC/QA
Class B gloves Visitors
Employees : Officers
Employees : Workmen
Employees : Maintenance
Employees : QC/QA

         

- Prepared by Checked by Approved by

Name and
Designation
Date
           HISTORY OF REVIEW

DATE SUPERSEDE No. CCF No. REASON FOR REVIEW

5.0 FLOW CHART:

6.0 APPENDICES:
7.0 REFERENCES:

8.0 REVISION HISTORY:

Date Version No. Reasons for Revision

- Prepared by Checked by Approved by

Name and
Designation
Date