SOP - Standard Operating Procedure

SOP - How to Write a Standard Operating Procedure -- Example

Scope
This document applies to the preparation of an SOP (Standard Operating Procedure).


Procedure Description
The procedure -How to Write and structure all SOPs to establish a consistent approach for the SOP writing process.

All SOPs must contain the following:
The Header  section should including the SOP’s title, number ID and version.
The Footer contains the SOP’s author name, page number of, creation and approval
dates.
The Scope is to whom and what the document applies.
The Standard Operating Procedure Aims to harmonize the procedures carried out.
The SOP or Standard Operating Procedure describes the steps to perform the procedure. Where necessary will refer to supplementary documentation.
The Standard Operating Procedure describes the Materials used.
It describes the Equipment, its function and operational steps.
The SOP brings up all supplementary Documents, and cross-references
with other SOPs, as well as their location both electronically and hardcopy.
It addresses all Safety issues regarding the task.
The Standard Operating Procedure states where to annotate and keep records (electronic and hardcopy).
The SOP assigns Responsibility for the procedure. Name and dated
signatures are mandatory for SOP author, reviewer, and approval.
Authors, Reviewers, and Authorizing Signatures should be attached at the
end of the document, with date of approval.

How to write a SOP - Template ready to use - All documents are FDA and EMEA compliant, Good Manufacturing Practice - Standard Operating Procedure

Process:
This document gives detailed instructions to consistently perform the work, in a consistent and repeatable fashion. It may be useful for training; however, is not intended to replace it.
When the process involves numerous steps, SOPs should be written to describe sub processes (i.e. a buffer preparation, necessary for an analysis), and cross referenced by title/ID.

Format:
The SOP should be divided in sections (where appropriate):
Header/Footer
Scope
Objective
Materials
Equipment
Documentation
Safety
Records
Description
Document formatting:
Header/Footer
Maintain style and consistency across documents to assist in their readability.
State scope and objective at the beginning.
Give a descriptive title. Provide a tentative ID.
Illustrate the procedure by dividing it in small steps, described in one sentence.
Emphasize topics where mistakes are more likely to occur.

Further Examples and SOP Template download on GMP Online Consultancy - The Experts for a compliant GMP Quality System


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