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. 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.
GMP training is an important part of manufacturing and testing pharmaceutical products. It is the means of ensuring employees can properly perform their job to specified standards. Those standards ensure products are manufactured consistently, in a controlled manner, and to defined quality specifications. Training employees on a regular schedule, with job specific instruction, and thorough documentation help our company meet our standards of manufacturing and testing of our pharmaceutical products.
The objective of validating a procedure is to demonstrate that the procedure is suitable for its intended purpose. This extends to all SOPs. They must be validated to prove that they accomplish their purpose. There are many different processes that can be validated in pharmaceutical operations. Some examples include, but are not limited to, process chemistry, analytical testing, lab facilities, cleaning, equipment, packaging, etc.
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