SOP on How to Write a SOP
Objective: This document describes the basic needs / requirements in writing an SOP. It also explains about the type of information and /or instructions should be provided in a procedure. It also gives information for the design of data record forms.
Need of SOP: The purpose of any written procedure is to provide a documented plan for what to do in certain situation(s).
Benefit of SOPs: The Standard Operating Procedure serves in reduction of errors resulting from verbal procedural information among personnel.
Development of SOP:
1. Who writes SOP: The procedures are prepared by a staff member who regularly performs the activity himself or who immediately supervises it.
2. SOP Language: The statements / information is given in a concise, easily understood form. The language used is simple and direct i.e. words are short, simple, and declarative, with each expressing only a single idea.
3. SOP Number Assignment: Each SOP has been assigned a number controlled by Quality Assurance. Records of number assignments are maintained in a logbook, indicating the S.No., SOP number, the date of issue, pertaining to department / activity, a preliminary title.
4. SOP Review and Approval: The SOPs are reviewed by the personnel who use them and they inform to the supervisory staff and / or to the department manager for any deviation.
The procedures are reviewed frequently, at least annually to update the information. Any significant change in the processing event, first it is approved by Quality Assurance or Quality Control before the change can be instituted.
The following persons sign the SOPs –
a. The person who prepared the SOP.
b. The person who checked the SOP.
c. The person who approved the SOP.
5. SOP Distribution and Control: The set of SOPs are distributed to Quality Control and Production Chemists and the master copies are kept with the Quality Assurance. The location SOPs are placed in the specific area of the facility.
The following format may be utilized in writing a Standard Operating Procedure.
1. Name of the facility: Defines the SOP belongs to Company Name.
2. Title: The title in a SOP is written in brief and direct, describing each procedure in a way that identifies its purpose.
3. Purpose: The purpose in a SOP describes that the reason for writing a procedure or why is it being performed.
4. Scope: It indicates that when the procedure needs to be performed and where it is to be applied.
5. Responsibility: It defines the person responsible for performing the job / operation cited in the SOP.
6. Materials and Equipment: This part of SOP describes the materials & equipment required to perform the test or job.
7. Procedure: This explains a clear concise, step-by-step instructions on how to perform the procedure. Procedures are written as instructions for the operator to follow. The procedures also include –
a. Preliminary steps that must be done before beginning the actual procedure.
b. Safety considerations are included in the SOPs. These includes precautions for work with physical, chemical or biological hazards.
c. The chronological instructions are given as the step number.
d. Calculations are explained, wherever required.
8. Documentation / Reporting: The SOPs defines the records to be maintained or completed during the various activities e.g. logbooks, batch records or forms etc.
9. Reference Documents: The SOPs also list other SOPs which directly affect or are relevant to this procedure e.g. the SOP for preparing a buffer used in the procedure, or the SOP for the operation of a piece of equipment used in the procedure.
10. Reason for Review: If any