What Students in Pharma Courses Should Know About Standard Operating Procedures

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Standard operating procedures (SOPs) might be found in almost any industry, but they’re of particular importance when it comes to pharmaceutical and food manufacturing, where strict quality assurance and quality control procedures are integral to maintaining public health and safety. In 2017, for example, the most common observation listed in FDA 483 forms for inspections in the drug sector was “Procedures not in writing, fully followed.” The fourth most common was an absence of written procedures, and the fifth was written procedures not being established or followed for the cleaning or maintenance of equipment.

The issue of written procedures, then, is clearly an important one, and students in pharmaceutical training will likely be interested to know more about the role that SOPs play, how they’re written, and how to ensure they meet the requirements expected of them.

The Purpose of Standard Operating Procedures

Standard operating procedures are sets of written, step-by-step instructions that document exactly how to perform a specified routine activity. In a pharmaceutical manufacturing context, this could mean instructions for how to sanitize a particular machine or area, how to test or package a particular product, or how to handle oral or written complaints.

These documents can be used to train new employees, but more generally, they help employees minimize or eliminate variation and carry out important routines in an efficient, correct, and consistent way, making them an integral part of pharmaceutical quality assurance.

How Students in Pharma Courses Can Write Clear and Easy-to-Follow SOPs

There are many standard expectations when it comes to SOPs, which need to be written in a particular way so as to avoid any possible areas of confusion and to ensure that the steps can always be clearly understood and followed by those referring to them.

SOPs should always be written in the present tense and use an active, rather than passive, voice. The language used should be straightforward, simple enough to be easily understood but with a level of detail sufficient for any employee to clearly grasp every step of the process being described. Ambiguity and vagueness should be strictly avoided. Exceptions and warnings should be highlighted with a larger font and/or warning icons. For bilingual and multilingual workplaces, translations should always be included.

When presenting a decision, there should be a clear delineation of how and when the decision is to be made, by whom, and with consideration of which factors. SOPs should also specify who ensures a given process is working, who is accountable if something goes wrong, and who is responsible for changes to the SOP itself.

SOPs Can Be Presented in Several Different Forms

While written step-by-step instructions are likely the most common form for SOPs to take, there are other acceptable ways of presenting the information as well. The exact format used should ultimately be whatever fits the material best, and whatever communicates it most clearly to the employees that will be expected to use it.

Some other forms used for SOPs include general descriptions in paragraph form, flow charts, and pictorials. Combinations of these forms can also be used if they improve the clarity or comprehensibility of the document.

Students in Pharmaceutical Quality Training Learn Valuable Skills for Writing SOPs

By studying good manufacturing practices and the principles of quality control and assurance, and developing their abilities in technical writing and scientific communication, students in pharma courses can gain the skills they need to write clear and easy-to-follow SOPs for pharmaceutical manufacturing environments.

 

SOPs are particularly important in the pharmaceutical manufacturing industry

SOPs are particularly important in the pharmaceutical manufacturing industry

Are you interested in training for a career in quality assurance?

Contact AAPS College to learn more about our pharmaceutical quality training program.