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
III. RESPONSIBILITY
IV. PROCEDURE
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.
VI. FORMS:
Logbook
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.
