Standard Operating Procedures (SOPs) are an essential component of Good Manufacturing Practices (GMP). If a process is to be done, it will have an SOP that describes how to do it. SOPs cover topics such as manufacturing, testing, training, management, documentation, lab facilities, cleaning, change control, deviations, and anything else you can think of. It might seem redundant from the outside looking in, but it is a major way for ensuring that pharmaceutical products are produced with consumer safety as the ultimate priority. For the sake of this article, it will mainly focus on manufacturing and testing.
SOPs are meant to be followed exactly as they are written. Improving a manufacturing process is an ongoing goal of GMP. In order to improve a process, procedures must be performed exactly the same way every time the process is performed. The process is treated like an experiment, where all variables are controlled for, as best as possible. Following SOPs is the way of controlling the variables. When a process is repeated, observations of variations will inevitably be made. It’s from observing deviations and variance that changes can be made and improve the process over time.
Improving the process is important, but the primary reason for following SOPs is to ensure that a quality product is manufactured. Following SOPs to the letter is how this is accomplished. This assumes that the SOPs are well written and specify what a quality product is. With a well written SOP that guides an employee step by step, the chance for mistakes that would compromise the quality of the product are reduced.
As mentioned above, there are many different types of SOPs. While documentation, facilities, etc. are important processes to have SOPs for, processes like manufacturing and testing are most pertinent. This is because manufacturing and testing SOPs have a direct impact on product quality.
For a company adopting GMPs into their process, this is the place to start. In both manufacturing and testing, the SOPs will describe exactly how processes are performed. Every piece of equipment used in the manufacturing process has its own SOP associated with it. It clearly describes how to use the equipment, how to service/qualify the equipment, and describes the equipment maintenance schedule. With the operating procedures for every piece of equipment, the processes that follows are clear.
While SOPs describe how to use the equipment, methods are the documents used to describe the execution of manufacturing and testing. A method is a written document, just like an SOP, that guides the manufacturing and testing, step by step. It is the ultimate guide for the process down to the details of manufacturing a drug substance. As an employee works through the method, they initial and date each step as proof that they completed the step exactly as it is written.
With SOPs and methods describing processes, the amount of variance is reduced. Employees will be performing tasks the same way, day to day, instrument to instrument. Reducing the variance improves the product quality, and reduces the chance for a compromised product. With SOPs and good training, there is a great reduction in opportunities for making mistakes. There are nearly no excuses for mistakes, aside from equipment failure, but that’s another story and another SOP.
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