What is a standard operating procedure? A person can roughly derive what it means and what it is all about from the name itself. An SOP comprises written instructions that document routine employees follow in a company regarding operations. They are helpful in that they help in the provision of consistent results. They can be used in many organization types, and life science companies are significant users of SOPs. Life science procedures always need a specific result, and SOPs are the best way to get there. Using and maintaining the best practices in SOPs is crucial.
Life science organizations have a lot of procedures they have to go through in any project life cycle. The life science company umbrella contains companies that deal with research, development, manufacturing pharmaceuticals, biotechnology-based food and medicines, and many more. For success, the best operating procedures must be put to use. SOPs vary from industry to industry. Life science companies should use SOPs for Life science organizations to get the best results. In doing so, the best practices should be observed.
Purpose of Standard Operating Procedures
Before unveiling the purpose of SOPs, it is vital to know that it is a necessity and a requirement. Regulatory bodies such as the FDA and International Standards Organization warrant that companies have and follow SOPs. Here are some of the primary purposes of SOPs for life science organizations.
- Document activities to be taken within the organization to create consistency in technical operations and support data quality.
- Describe analytical processes, validation, qualification processes, and processes for maintaining, calibrating, and using the equipment.
- They ensure compliance with regulations in place for quality control and quality assurance.
Having an SOP is vital for any life science organization. Many life science organizations can fall within another same subcategory where they have similar practices in operations. However, formulating an SOP is the tricky part. The SOP should match the organization’s needs, and one of the easiest ways to have an effective SOP is getting a pre-packaged SOP. A pre-packaged SOP is the easiest way to get a proven routine for an organization. The pre-packaged SOPs include templates for select IT or Quality processes based on standard regulatory requirements and industry best practices.
Support for Writing Custom SOPs
SOPs can be gotten as a service from a service provider. Hiring a department to be writing SOPs can be costly, and getting support for writing custom SOPs might be the best way forward. A custom-written SOP is more advisable for people looking for a more tailor-made solution unique to their companies needs. The SOP writers will need to look at the current state of the SOPs and their performance. From there, it can be modified and customized to meet the organization’s needs. SOPs for life science organizations are crucial and significantly affect the company’s performance. It is also pivotal to be in line with regulations.