Standard Operating Procedure for Pharmaceuticals
Standard Operating Procedures, commonly referred to as SOP’s, are detailed written instructions describing specific steps to follow in all pharmaceutical activities under defined conditions. Quality performance and quality products would further necessitate the presence of standard operating procedures, which ensure the continuity of the processes.
In a general perspective there exist many ways of writing SOP’s, but the purpose of this paper is to ensure individuals in the field of pharmacy, write down what they do, and at the same time have an opportunity to review what they are doing. Though SOP’s reflect differently on how pharmacies operate, there are general principles that must apply. These include; SOP’s should be pharmacy specific, should be dependent on the competence of the staff working in that pharmacy, and at the same SOP’s should be applicable at all times and not dependent on the presence of the pharmacist under whose authority the procedure was prepared.
Other than unexceptional circumstances, SOP’s should ensure recommended procedures at all times be followed. Teams should write SOP’s, this ensures comprehensive knowledge acquired from different perspectives will apply to the SOP. Writing SOP’s should not involve the use of many and complex word, instead, instead, short sentences and some bullet points might work best to create flow and sequence in the SOP.
An SOP should include a title that defines its purpose. Link SOP’s by using document reference numbers if necessary, and add revision dates on the title or cover page, and the first page of the text. State the purpose of the SOP including information about processes and regulatory standards. Job description should also be included, for instance, a technician may apply to use to describe levels of responsibility if there is a high turnover of staff. The use of names instead of descriptions may mean amendment of SOP each time a member of staff leaves. In addition, a scope statement should be written, that tells what related subjects the SOP will not cover, if there is any chance someone will be confused and make a mistake. Scope statements are useful because they focus the attention as a writer and clarify things to the reader much more to enhance understanding of the dangers and procedures.
Another procedure is that, one should also give an overview of the steps in the SOP that best describes the process in terms of its major functions. Anticipated safety should be included, health, environmental and operational issues. Definition of terms and concepts should appear if an SOP formate contains information that readers may be unfamiliar with due to language difficulty. A glossary may fit better the long list of terms used, if the writer decides to keep a simple list of terms, then the list should be included in the write up. Furthermore, there should be an inclusion of safety warnings, cautions and notes before description of the actual step. Lastly, and in conclusion, the list should be in a sequential order in which an SOP user should perform the steps.
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