Introduction to Standard Operating Procedures:

As a part of the concept of GMP (Good Manufacturing Practices), the pharmaceutical industry commonly uses SOPs (Standard Operating Procedures) in their daily routines. In fact most of the operations in the industry are done based on specific written procedures, commonly referred to as SOPs.

In order to implement GMP, SOPs are very much essential, and will be a very important component.
This SOP Guide has been prepared, in order to assist the pharmacists to get an insight into SOPs, familiarize them with the concept of SOPs and their importance. In order that a pharmacy incorporates SOPs in their routine procedures (right from procurement to dispensing, to handling complaints, or offering professional services), certain benchmark SOPs have been included, which would guide pharmacists to write their own SOPs in their respective pharmacies.

Standard Operating Procedures:

(1) What is a Standard Operating Procedure (SOP)?

A Standard Operating Procedure is a written step-by-step procedure for an activity carried out in a particular organization (community pharmacy in this case).

Quite simply, a SOP specifies in writing :

  • what should be done,
  • when it should be done,
  • where it should be done, and
  • by whom should it be done.

(2) Who can write the SOPs ?

  • A pharmacist in the pharmacy can write a SOP, and this can be checked, corrected, and approved by a senior/experienced pharmacist from the pharmacy. Further modifications can be made depending on its applicability & usefulness, after actually testing the SOP in the pharmacy.
  • Timely review of SOPs should be done, to assess for validity, and to take care of any changes in certain processes/practices which may be eminent with changing times.
  • The other staff in the pharmacy may be involved/consulted before, during and after writing the SOP. This can be done both to encourage everyone’s participation, as well as to make all the staff aware about the new concept being introduced.
  • Any changes/reviews to existing SOPs should be brought to the notice of every staff at the earliest.

(3) What are the benefits of SOPs?

  • SOPs give clarity to the pharmacy personnel, to follow steps/procedures, systematically, and
  • uniformly.
  • SOPs assist the pharmacy personnel to know who does what, and when, thus avoiding confusion, and function overlapping. This also takes care of accountability and responsibility.
  • SOPs assist to ensure that GPP is followed and achieved at all times.
  • SOPs are useful tools for training new members of staff.
  • SOPs help to assure the quality and consistency of the service, and thus minimize harm to the patient.

(4) What do SOPs contain ?

Since each pharmacy operates and functions differently depending on varying circumstances, and has its own ways of carrying out certain procedures, the SOPs in different pharmacies will differ. However, the basic content, structure, and the concepts of SOPs will obviously be the same.

Some of the important contents of SOPs are :

  • Name & Address of the Pharmacy
  • SOP number, and Date when the SOP was prepared/reviewed.
  • Aim or Objective of the SOP
  • Scope of the SOP (area which will be covered by the SOP)
  • Process/Steps to be carried out, in sequential order.
  • Whose responsibility it is to carry out the SOP.
  • Any other useful information
  • Name and signature of the person/s who made/reviewed the SOPs, along with date of review.

Pharmacists should make SOPs to cover different aspects/functions that are carried out in a pharmacy, and following legal & ethical procedures should always be kept in mind while writing and following the SOPs.

The contents should be in simple, clear, and lucid language, non-ambiguous, and easy to understand to all the staff.

SOPs should define specific processes, and also specifically identify which functions are to be specifically done by pharmacists, and which could be done by other trained non-pharmacy staff.

SOPs should be neatly typed, have an aesthetic yet professional and serious look. The flow of matter should be complementary with the flow of the activities/process to be performed.

(5) Where to keep the SOPs?

  • SOPs should be readily available to the relevant staff at all times.
  • A master file of all SOPs should be maintained, which should be securely kept with the Pharmacist in charge.
  • All SOPs may also be kept in another file, which is easily accessible, for reference/use of the staff.
  • Certain SOPs may be put up in prominent places, at the point where they are actually applicable.

E.g. A SOP for handling medicines in the refrigerator may be pasted on the refrigerator door.
E.g. A SOP for taking clinical measurements (like blood pressure, blood sugar, etc) may be kept on the
table or area where such measurements are carried out.

Reference SOPs:

This booklet gives certain reference SOPs for various activities carried out in a community pharmacy. Each pharmacy may operate differently, therefore SOPs should be prepared in a way to reflect this. SOPs should therefore :

  • Be specific to an individual pharmacy
  • Be dependent on the number, type, and competence of the staff working in that pharmacy.
  • Lay down steps to be carried out in normal circumstances, and also specify what needs to be done when normal circumstances break down e.g. staff is absent.

The reference SOPs in this booklet may not be applicable on an “as is” basis to every pharmacy, because each pharmacy functions differently, and in different circumstances. Therefore, each pharmacy should tailor the SOPs to suit the individual pharmacy and meet the above criteria as well.
While preparing SOPs that are pharmacy specific is important, they should also allow for the continual
improvement in service to clients.

Standard Operating Procedures not only lay down a standard procedure for carrying out activities but also help to avoid confusion over who does what by role clarification within the pharmacy.

 

Reference: Good Pharmacy Practice – I.P.A. – C.D.S.C.O. – W.H.O. INDIA COUNTRY OFFICE