To design a Standard Operating Procedure that describes the preparation, approval, authorization, control, and revision of Standard Operating Procedures.
2.0 SCOPE:
This SOP shall be applicable to all SOPs
3.0 RESPONSIBILITY:
The executive person, Head of the department, and Director are responsible for the preparation, approval, authorization, control, and revision of the SOP.
4.0 INTRODUCTION:
A Standard Operating Procedure is a document that consists of step-by-step instructions intended by an organization to help the person carry out the operations. Its use is an integral part of a successful quality system as it provides individuals with the information to perform the job properly and facilitates consistency in the quality and integrity of the end result. An SOP should be available at the place where the work is done. SOPs used in the system are Departmental SOPs, Instrumental SOPs, and Experimental or Test SOPs.
5.0 PROCEDURE:
5.1 SOPs shall be in clear, unambiguous language, easy to understand, and easy to follow.
5.2 The SOPs shall be under the following sub‐headings.
· Objective: This section covers the reason for preparing the SOP which shall be in one sentence or a maximum of two sentences starting with the letter ‘To’.
· Scope: This section defines the applicability of the SOP along with the specification of departments, areas, or sections to which the SOP shall be applicable.
· Responsibility: This covers the designation of the person/persons who are directly responsible for the operations mentioned in the ‘Objective’ of the SOP.
· Introduction/General Information: This section covers in-house and Instrumental SOPs or whereas required.
· Procedure: The procedure/methods/instructions shall be in short sentences instead of long paragraphs. Records, frequency of various operations, checks, and special precautions shall be mentioned if any.
· Precaution: Essential precaution only for that particular SOP shall be mentioned in short sentences.
· References: This section covers the list of references or any other guidance documents based on which the SOP has been prepared. If there is no reference for the SOP, Not Applicable shall be mentioned under the subheading.
· Abbreviation: The list of all abbreviations & their full forms/descriptions used in the SOP shall be mentioned. If there is no abbreviation in the SOP, Not Applicable shall be mentioned under the subheading.
· Definitions: This section covers Experimental and Instrumental SOPs or where required.
· Annexures: Annexures shall be added at the last of SOPs if required.
5.3 Format & Margin Requirements:
The type of font for the contents in SOPs shall be ‘Arial’. The font size and margins to be used for the contents of SOPs shall be as follows:
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CONTENTS OF SOP |
FORMAT & MARGIN |
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HEADER |
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Header from top |
0.1” |
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Table Size-Height” and
Width” |
0.49” & 1.64” |
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Table-‘Columns’ &
‘Rows’ |
2 & 5 |
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Table Rows Spacing |
1.0 |
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Institution Name (Centre
Text) |
12 Bold in Upper Case
(Agency FB) |
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SOP title |
11 in Upper Case (Time
New Roman) |
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SOP No |
12 in Upper Case (Time New Roman) |
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Issue Date |
After 2 Years shall be
changed |
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Issue no |
Not given in Header
shall be explained in history |
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Review date & no. |
Can be with approval to
QA with reason in history |
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BODY |
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Heading |
12 Bold in Upper Case |
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Subheading |
12 Bold, Underline,
Capitalization Each Word |
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Write up of SOP |
12 in Sentence Case |
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Page Size |
A-4 |
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Page Margin-Top, Bottom,
Left, Right. |
Narrow- 0.5”, 0.5”,
0.5”, 0.5” |
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Line Spacing |
1.5 |
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Paragraph Spacing |
Single Enter |
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Heading &
Subheading Format |
1.0________________ 1.1________________ 1.1.1_______________ |
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Bullets |
·
(Circle Black dot) |
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FOOTER |
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Footer From bottom |
0.2” |
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Table Size-Height” and
Width” |
0.29” & 2.11” |
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Table Rows Spacing |
1.0 |
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Page No. Format |
‘Bold Numbers 3’ at
Right bottom |
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Table-‘Columns’ &
‘Rows’ |
‘3’ & ‘3’ |
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Prepared by |
12 in Capitalization
Each Word |
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Reviewed by |
12 in Capitalization
Each Word |
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Approved by |
12 in Capitalization
Each Word |
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Signature Block |
A uniform and blue pen
shall be used |
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5.4 Numbering System of SOP
5.4.1 To each SOP shall be allocated a unique numbering system. Once the number is allocated the same number shall not be repeated to other SOP.5.4.2 Each SOP No. consists of specific alphanumeric characters which shall be as follows Document type (SOP)/ Department Code/ Serial no. Ex.SOP/AHF/000.
5.5 Preparation and Approval:
5.5.1 User department in which the activity starts shall originate a draft SOP.
5.5.2 User department shall prepare the draft SOP as per the procedure described in point no. 5.2 to 5.4, a draft copy shall be identified by a watermark on each page.
5.5.3 Draft SOP shall be reviewed by the head of the department for technical adequacy and accuracy. The head of the department in which the SOP originates shall ensure that the SOP is accurate, adequate, and acceptable to all the concerned departments.
5.5.4 Any correction or review comment shall be discussed, resolved, and corrected between the user department(s) mentioned and QAU. At the end of this stage, the SOP draft is deemed approved.
5.5.5 Once SOP is approved, the user department shall conduct training on the respective SOP in coordination with the training coordinator.
5.5.6 The issue date for implementation of the new SOP or revised SOP shall be mentioned in the header only after training.
5.5.7 The photocopy of the training records of the new SOP / revised SOP shall be attached to the Master SOP.
5.5.8 The SOP approval shall be as follows:
· Prepared by: Department personnel who prepared the SOP.
· Checked by: in charge of the department(s) to which SOP belongs/in charge of the relevant department where the SOP is affected. (In the case of General Practices SOPs QA Head will be acting in charge.)
· Sign after ensuring that the SOP is accurate, adequate, and acceptable to all departments and annexure mentioned (if any) in SOP is accurate.
· Approved by: Director/ Designee should sign after ensuring the SOP is checked and signed by in charge of the department to which the SOP is assigned.
· The draft copy shall be destroyed after the final SOP is made effective.
5.6 Review of SOP:
5.6.1 All SOPs shall be reviewed over a period of two years or whenever a change is required.
5.6.2 Whenever SOP is reviewed, the changes made shall be entered in the revision history of the respective SOP.
5.6.3 In case there are no changes required for the existing SOP during the review period, the procedure to be followed as per the SOP preparation, distribution, control, and review of the document.
5.7 Issue and Control
5.7.1 Original copies of SOPs shall be stamped as “MASTER COPY” in red color ink at the top right side of each page.
5.7.2 Control and Distribution SOPs shall be controlled and Distributed as per the procedure mentioned below.
5.7.3 For the preparation of controlled copies for distribution, the photocopies of the master copies shall be taken and shall be stamped as ‘CONTROLLED COPY’ in green ink at the bottom right side of each page.
5.7.4 The copy number shall be corresponding to the department code to which the controlled copy is being issued as per SOP department codes. A first controlled copy shall be issued to each department and a second copy shall be issued as a display copy.
5.7.5 The record of issuance, retrieval, and destruction of different documents shall be maintained on the form ‘Document Distribution, Retrieval & Destruction Record’.
5.7.6 The controlled copy of the respective master document shall be distributed to the concerned department (s) and the initials of the distributing QA personnel and receiving by respective departmental personnel shall be taken on form ‘Document Distribution, Retrieval & Destruction Record’. Issue the new revision only after the retrieval of the issued controlled copy of the previous revision.
5.7.7 In case any additional copy of the “MASTER COPY” is required by the department for further usage, a request for additional issuance shall be raised to the QA department with proper justification and approval from the Head of the department on the form “Request for Additional Issuance of Documents”.
5.7.8 In case the additional copy is required for any external agency / any department for reference purposes, the same shall be issued by photocopying and each page shall be stamped as “UNCONTROLLED COPY” in black color ink at bottom of the center of each page. In such cases, the record of distribution shall not be maintained.
5.7.9 Respective department head shall keep a track of the documents due for review.
5.7.10 SOP shall be issued within 30 days after the date of approval.
5.7.11 Department head shall prepare and update the SOP index as per SOP No. SOP/AHF/000 (in case of General SOP shall include in QAU dept.)
5.7.12 Other than Archive copy (Master Copy) remaining copy shall be marked as “OBSOLETE COPY”.
5.7.13 Formats for records or sheets shall be attached as Annexure-1, 2, 3…etc.
6.0 PRECAUTIONS:
6.1 Eating, drinking, and smoking are strictly prohibited on any premises of the laboratory animal facility.
6.2 All the visitor(s) shall be accompanied by the facility supervisor and/or departmental staff during the visit.
6.3 No visitor shall be allowed to enter the facility without the permission of the director and/or facility supervisor.
7.0 REFERENCES:
7.1 Amare G. Reviewing the values of a Standard Operating Procedure. Ethiopian Journal of Health Science. 2012. 22(3): 205-208.
7.2 Bhattacharya J. Guidance for Preparing Standard Operating Procedure (Sops). IOSR Journal of Pharmacy. 2015: 5 (1); 29-36.
8.0 ABBREVIATIONS:
SOP : Standard Operating Procedure
AHF : Animal House Facility
No : Number
PCD : Pharmacology Dept.
TOX : Toxicology Dept.
RAU : Regulatory Unit
QA : Quality Assurance Officer
QAU : Quality Assurance Unit
CHM : Chemistry Dept.
MIC : Microbiology Dept.
CAN : Cancer Unit
HIS : Histopathology Dept.
ADM : Administration Dept
Dept. : Department
9.0 History of the SOPs
9.1 History table shall be printed on the back side of the last page for easy access. It shall contain the following details.
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Sr. No. |
Date |
Date of Revision |
Reason for Review |
Issue No & Date |
Revision No. & Date |
Reviewed by (Two Reviewers)
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Approved By |
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10.0
Training of the SOPs
10.1 Training table shall be printed on the back side of the last page after history records. It shall contain the following details.
Training
Record
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Name of SOP &
Code:____________________________________________________________ SOP Trainer Name:______________________________________________________________ |
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Sr. No. |
Date |
Name of Trainees (Attendance) |
Signature |
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END OF THE DOCUMENT
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You may like to read these links:
1. List of All SOPs and Documents for the Microbiology Laboratory
2. List of All SOPs and Documents for In-vitro Laboratory
3. List of All SOPs and Documents for the In-vivo Laboratory.
4. List of All SOPs and Documents for Clinical Research
5. List of Instruments and Equipment Used In Laboratory Animal Facility
6. List of All SOPs and Documents for the Animal House Facility
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