We made a video to help you understand what standard operating procedures are. For this, we interviewed Tania Schmit, our quality manager.

Hello everyone, I am Vanessa Montanari, Managing director of Pharmaspecific. I present Tania Schmit. Tania is a quality consultant. She is also quality responsible for Pharmaspecific.

Tania, I thank you for your presence and for agreeing to answer my questions to enlighten the readers of our blog. Today we will discuss standard operating procedures.

My first question is: what is a standard operating procedure?

A standard operating procedure is a document that describes a specific activity. That is to say, in this document, we will find the chronological description of how the operations of a specific activity will be carried out. For example: conducting a monitoring visit, recruiting a new employee…

In this document, we will also find the actors involved and the persons responsible for carrying out each operation. We must also specify the means that will be used to carry out this activity either a computer, a machine, an apparatus, a car, for example. To finalize, it is also necessary to determine the ancillary documents that will be used to carry out the activity; either a form, a quote for example. A procedure may involve several services or activities of a company.

What are the standard operating procedures for?

A standard operating procedure serves several purposes:

• Formalization of an activity: if we have doubts about how to carry out the activity, we can refer to the written formal procedure and this is where we will find the precise explanation on the realization of the activity.
• The training of a new employee: any new employee of the company must be trained on the specific activities that concern him. From this perspective, we can initially give him/her the procedures to read so that he/she can begin to understand the tasks that will be entrusted to him/her. Following this, field training will complement the understanding of his/her work.
• The formalization and archiving of the company’s know-how for its sustainability.

 I would also say that carrying out procedures is used to identify possible dysfunctions in the performance of certain activities. Since we have to describe in a procedure what we do in the field in a logical and orderly way, we can eventually identify tasks that have no reason to be involved in the activity.

In what framework are standard operating procedures written?

There is no specific framework for writing procedures. All companies or organizations can create their own procedures to better understand and make clear their activities. In this context, we can write procedures if we want to formalize our activities. If we want to create a quality management system or if we want to start a process of certification of the ISO 9001 quality standard or another standard.

 Tania, who can write standard operating procedures?

It is strongly advised to involve employees in writing procedures. This exercise will help them understand this document. Let us not forget that it is the employees who are the main users of these documents. It is recommended that a quality correspondent or someone with expertise in this field should be able to supervise the drafting of these documents.

Yes, indeed, Tania, at Pharmaspecific, it was the collaborators who took an active part in the drafting of the procedures with your help. This is an important point that allows them to get involved in the company’s quality approach.

How do you write a standard operating procedure?

In the procedures we must specify the following points:

• Steps and sub-steps leading to the completion of the activity
• The actors and those responsible for these operations
• And the means and documents that are used

 It is also advisable to have a system of identification for the procedures as well as to determine the persons responsible for the drafting, the verification and the validation of these documents. Finally, we can present our procedures in two ways: the first, editorially and the second, with the help of a flowchart.

Tania, thank you for clarifying the standard operating procedures. We have obtained ISO9001 certification with your help. Thanks again Tania.

Thank you all to have watched this video, to learn more about Pharmaspecific, you can click on the company’s website. See you soon,

Written by Vanessa Montanari

You need a service in clinical research? Contact PHARMASPECIFIC by visiting our website by clicking here: https://pharmaspecific.com/devis/.

If you have questions about being a clinical research associate or a career in clinical research, you can put them in the comments below. We will respond to you as soon as possible.

If you want to be coached, if you want a personalized answer to your questions or if you want to be in contact with other clinical research professionals, you can go to https://pharmaspecific-training.com/.{:}