Hi guys! Today I will impart to you how to write your own SOP. I know why are you here. I wonder if a FDA inspector have lately inspected your office and looking for your SOP; however, you have nothing to provide, and he commanded you to create your pharmacy's own Standard Operating Procedure or else it will turn out as a deficiency and violation.
What is SOP?
Standard Operating Procedure (SOP) according to FDA Philippines is a document that describes “ how to perform” various routine operations that contains step by step instructions. It is written by the individuals who perform the operation and who share some aspects of the operation. SOP is needed to guide personnel when and why to perform a task, and what is the scope of the task. The SOP must undergo series of reviews and approvals before it can be imposed. Individuals who can be knowledgeable to review the procedure and who can be higher up in the hierarchy of the department are the possible reviewers and can approve the tentative manual.
In the previous blog, I showed you the format and the contents of SOP according to FDA Phil. By following it so, you can easily make your own SOP of your Pharmacy. Usually the Pharmacist is tasked to make it and reserved the right to create according to the operations that he seems to be applicable to his workplace. So that you can begin doing so, I will give you some tips and hints to make your own SOP.
Creating Your SOP
First you need to think of the important functions and tasks in your pharmacy other than the basic contents that required by FDA Phil. For example, if your company is engaging in distribution you should create a SOP for Good Distribution Practice; moreover, in an instance of compounding drugs there must be a SOP for Good Compounding Practice, so that each of the staff will sternly follow one procedure and operation, and procurement of raw materials, pull-outs and returns and others need a SOP to harmonize the work and avoid mislead or errors. The language of your SOP should be clear, in an active verb forms for procedural directives and should be direct to the point. Use language that can be easily understood. You may use Filipino or other native dialects to reach those who cannot understand English much. Be considerate, remember that almost all the tasks and operations are performed by employees that may not be eloquent enough to understand the manual in English. To start with, the following are the main content of the SOP objective, scope, responsibility, procedure, quality records, forms and end of document.
- OBJECTIVE – describes purpose of the goal and aim.
- SCOPE – up to what extend can be the task performed
- RESPONSIBILITY – who can be involved in performing the task.
- PROCEDURE – the step by step action of doing a task
- QUALITY RECORDS – how to do records and uphold them
- FORMS – to where the records are written (Optional)
- END OF DOCUMENT – can be used to place additional information and rationale
Sample of Standard Operating Procedure
I. OBJECTIVE: To provide proper guidelines in procuring of stocks.
II. SCOPE: Applied to all products
- The procurer will make an order through phone, SMS, facsimile, sales representative and other media.
- There should be a copy or list of the products to facilitate checking of them when delivered.
- Upon delivery of the product, check the product's count, amount, batch no. and make sure that the expiry date is very far to make sure the product is safe and effective.
- The procurer will pay the delivery man and ask for official receipt and copy of the sales invoice and filed them.
- The procurer will price the product through an acceptable price mark-up.
- The product will then display and ready to be sold.
V. QUALITY OF RECORDS:
The purchaser will file the invoice for future use and other cases.
VII. END OF DOCUMENT
Important Things to know!
Now that you have knowledge and skills in making SOP you can now start doing it. I just want you to remember other things about SOP. The writer, reviewer and editor must affix their sign over their names when completed. Manual should be reviewed regularly and kept up to date. A system of revision should be clear before any reform is made. All documentation should be made available on request of competent authorities, if possible, all personnel encompassed are given a copy which become their personal guide. Records should be made at the time each operation is performed so that in such a way all the significant activities are traceable. All records must be readily retrievable, stored and retained.