TIPS FOR PREPARATION OF STANDARD OPERATING PROCEDURE (SOP)

Development and use of Standard Operating Procedures (SOPs) are an integral part of the effective and sustainable quality management system of any progressive pharmaceutical company. The expectation of SOP is to fulfill both; a combination of technical and fundamental requirements through its instructions.

Successful and error-free operations are completely reliant on effectively-prepared SOP. The success of the SOP is depending on how effective the SOP is constructed by an author of that SOP. Based on my professional experience and expertise I would like to suggest 5 tips which are useful for the preparation of good Standard Operating Procedures. I have defined these tips as ‘5K’ tips for the preparation of standard operating procedures.

KNOW SUBJECT / TITLE OF YOUR SOP

Always try to keep a precise title for the SOP, you are preparing. Use user-friendly words for the title, do not use the long title for SOP. do not merge two subjects in one SOP, prepare SOP for a single subject, e.g., do not merge subjects like Handling, operation & cleaning of the same equipment in one SOP for the one equipment. Do not prepare common SOP for similar types of equipment but having different functional requirements.

KNOW FORMAT OF YOUR SOP

Setup the SOP templates according to user requirements. Use the current format of the document for the preparation of SOP. do not use obsolete format for preparation of SOP. select reader-friendly fonts and font size. Take care that the flow of headings and subheadings is arranged sequentially. use punctuation in the right places, take care about breaking sentences. Avoid grammatical mistakes and spelling mistakes. Take care about the spellings of homophones.

KNOW YOUR SOP READER

Before preparation of SOP understand the user of your SOP, avoid usage of difficult words in the SOP. always try to use active voice in a sequence of the instructions. Try to include subject-related images/pictures or flow charts in the SOP. highlight the important words/ sentences.

KNOW YOUR PROCEDURE OF SOP

Unless you know the procedure of the subject, you cannot construct an effective SOP. understand the steps of procedures in detail, discuss with personnel involved in the day-to-day operations. Draft the sequence of procedural steps and get it checked by core operating people. Conduct brainstorming sessions if required, accept, and implement the changes to the final draft.

KNOW YOUR EXECUTOR

Anticipate the problem may encounter during execution, and gaps may identify in SOP against the actual operations to be executed. Check trends of incidents/ deviations encountered in the past which are related to this SOP. Evaluate corrective and preventive actions assigned regarding to procedure applicable to this procedure. Imagine yourself, you are following the SOP prepared by you.