A Standard Operating Procedure (SOP) is defined as a written instruction that elaborates how a task should be performed including when, by whom and where. SOP plays a crucial role in ensuring consistent quality in the pharmaceutical products and best practices in the pharmaceutical unit. It also plays a major role in risk mitigation and therefore proper implementation of SOP is essential. Creating and maintaining SOPs could be a complex task. And, most of the SOPs are quite complicated to read and follow on a daily basis. They mostly contain too much of details and instructions which often increases the risk of errors. Writing effective SOPs for pharmaceuticals is all about documenting the right amount of details that help in carrying out a quality procedure without causing confusions. Many companies write SOPs that emphasize “how” but do not essentially cover “why.”
Here are a few tips on writing effective SOPs for pharmaceuticals:
1. Clear and Concise
An SOP should be clear and concise. Keep the sentences brief and use common and simple terms. Avoid using overly technical terminology if the same idea can be communicated using simpler phrases or words. Formatting is also important. If the SOP contains long paragraphs, use a better formatting scheme. Lists and bulleted items help in highlighting important information and help the user focus better on the instructions.
2. Periodic Review
It’s important to review and reconstruct the procedures periodically in order to simplify and improve the procedures. SOPs which communicate the same old procedures and are not reviewed periodicallyteach the staff to solve issues which might no longer exist. Reconstructing SOP includes listing and analyzing every step in a procedureand asking “why” in each step.
Long and complicated SOPs with too much of detailing are often difficult to follow. Try to keep your SOP simple and easy to understand. Take care to include all the important steps and break down the complex ones into smaller sub-steps for easy comprehension.
4. Use Pictures
Human brain processes visual information better than written words. To make your SOP easy to understand you can include pictures, diagrams, illustrations or flow charts. SOPs in which visual techniques are used to explain complex information are easier to understand and follow.
5. Do Not Include Too Many People
Including too many people isn’t a good practice for writing effective SOPs for pharmaceuticals. With too many people, there is an increased risk of errors and mistakes. Including lesser number of people will help you in accomplishing the task quickly. It also ensures that the SOP has been documented correctly.
6. Consider the Staff
While writing an SOP, keep in mind the people who would use it. Consider the knowledge, experience, education and abilities of the staff that will use your SOP to carry out the task. Write in way that would be easy for them to understand.
Once you finish writing an SOP conduct a thorough testing with people who would be using it. Make them follow the instructions to make sure that the SOP contains clear and concise information and no step has been left out. You can also test your SOP with people who aren’t familiar with the procedures to find out if the SOP has clear instructions or not.
Although SOPs vary from firm to firm, the basic format should remain constant as per the FDA regulations. FDA also mandates that the people who write SOP should be qualified and experienced for the procedure covered in the SOP. Several multinational firms also need to write SOPs in multiple languages.