In my opinion an SOP, should be created to ensure repeatability of a process/ procedure. That being said it should be implemented when they are finalizing the product. Such an example would be if we create a new surgical stapler,we would want to be able to test the claims/standards of the stapler and its repeatable usage, which an SOP would be needed.

Chris

Hi Luisa,

I certainly think that SOPs should be required during the research phase. SOPs help define the department’s standard practices and daily processes conducted to assure execution of research tasks in accordance with federal guidance. They should contain adequate detail to clearly guide research staff through a particular procedure and thereby establish uniformity in the everyday functions of the department. Thus, as Chris mentioned, it should be created to guarantee repeatability and reproducibility of a method.

If the product or process is still in a research phase or even development phase an SOP is needed either way. This is to ensure the tests are as repeatable as possible as was stated above and also to ensure that a documented test method is available to go hand in hand with any applicable results. This allows the SOP to develop along side the product/process as it is documented as well as its changes along with it.

Hi All,

I would agree with those that stated SOPs should be required during the research phase. Working for a start-up we did not have many SOPs in place. As more were hired we learned the hard way that without SOPs, everyone will be doing things differently and it can cause many issues. One of the first things we realized after having issues was that we needed SOPs and they had to be developed quickly. I believe that SOPs should be developed as soon as possible to avoid issues.

-Andrew Nashed

HI Luisa,

you raised a very good question that concerns many companies. A quality system is the backbone of any organization. it defines the structure of the organization as well as define the roles and responsibilities of each member in this organization. The SOPs provide employees with the required steps to achieve the quality defined in the quality system. In order to be GMP or ISO compliant, you have to have SOPs in place to define how GMPs can be achieved.

In research, SOPs are required to define data collection procedures, experiment setup, ensure collected data legibility and accuracy, and process repeatability. The absence of SOPs during experimentation may lead to miscalculation of data, misinterpretation of data, missed experiment steps, etc. Therefore, the presence of SOP is required to conduct any GMP experiment.

My opinion on this is, SOPs should not be required during the research phase. The main reason behind this is that during the research phase your project can take multiple phases. There could be second opinions or alternative ideas involved during the research phase. So there wouldn't be any benefit in involving SOPs and considering them during this phase. For example, during the research phase an idea is launched and two months later everyone decides to change the idea to the point where everything would need to be changed. Then SOPs created during the research phase would mean nothing. Yes they are important and they might save us big time if involved during the research phase. But this is not always the case. Sometimes they may just be in the way of launching a perfect project idea. I do not have any industry experience so there isn't much I can say on how it would be in industry. But based on my understanding I do not think SOPs should be required during the research phase.

I agree with Fady, if SOPs are not established during research, how can one ensure repeatability. I feel one can never have enough SOPs, if each and every operation of the business/research could have an SOP, it would make filling in positions at any point much easier. The only draw back to this, when SOPs need to changed, it can have a cascading effect, and create a lot more paperwork.

I believe SOPs are required for the research phase, because there should be steps on the thought process of you reaching that idea, exploring the different possibilities, creating different designs, as well as other things. The DHF includes files from the devices inception, and with good documentation practices in lies proper SOPs to document all aspects. The main purpose of SOPs is for there to be organization and checks and balances for everything that is done with the medical device. We are dealing with instruments that may be life or death in certain circumstances for humans, so it is important to have a proper process in place even in the research aspect.

Great question, Luisa.

From previous experience, I, myself, have been responsible while working in the research phase to create SOP’s. This is important even for research and development because SOP’s are needed for operating small scale equipment and testing equipment, even at the research stages. I would often create SOP’s for small scale equipment, testing equipment, and techniques while at the research phase of development.

since everyone have mention about why SOP should be required during research phase, i want to add some information about SOP. SOPs should be reviewed by appropriate individuals. Reviewers could include colleagues who will be using the SOP, Quality Assurance (“QA”) managers, research facilitators, lab manager(s) or governance managers. A reviewed and revised SOP is then submitted for approval by the SOP author. Some organisations have SOP committees who approve SOPs. Sometimes it is the responsibility of one person e.g. the QA Manager or Lead Nurse.

SOP's are standard operation procedures, this is included on all realms of QA, manufacturing, clinical/non clinical testing etc. SOPs is the document that describes what a trained individual needs to do to run certain tests step-by-step to achieve certain results or outcomes. SOPs are approved by the author, SOPs are needed in Design Controls and is required to have GMP and ISO 9001 certification and approval. Only those trained in SOP development can create one.

SOP’s are step by step procedure how to do something that is critical to quality ,safe operations and security.SOP involves procedure and work instructions .The correct level of details required depends on task complexity, level of detail increases with task complexity.If user become more experienced they do’t need to be reminded of all basics all time,level of details decreases .User’s high level of proficiency needs less of details.SOP goal is to ensure that user have enough information to complete the procedure without looking at other document.If SOP is too little ,user can’t perform their task correctl,If SOP is too much document seems too dense that nobody wants to use them.

SOP is basically a step by step instructions document compiled so that the workers can carry out a complex routine efficiently. I definitely think the SOP's should be written during research phase. In fact, I used to intern at a lab where we were researching on stem cells. Obviously, the very first time if you are running a procedure it will have its own process. But once you establish a technique/procedure that works and needs to be repeated exactly the same way for different samples, then an SOP is very beneficial. As an intern, I was following a SOP to do certain kind of a protein assay on different kinds of my scaffolds that I used to spin. There was even a SOP for electrospinning the type of scaffold so that it can be used a control and not play as a variable if cells are being seeded on them. Therefore, a SOP is very beneficial during research phase to maintain repeatability and hence accuracy.

The Standard Operating Procedures (SOP) is a very important document that is needed in describing the procedures needed to complete the making of a product and the steps involved. With the SOP, a set method is placed within to the company as to how to create a certain product. During the research phase, it is essential to take into consideration all the factors that will be involved within creating the end product. As a result, the SOP should be required during the research phase. If the SOP is mandated, then the research being done will be completed more efficiently. Research can be more specified into what steps will be involved and determine the most successful way.