A standard operating procedure (SOP) is a company’s documented method for its business processes. As such, it’s important to set up guidelines for those SOPs before they are written to ensure uniformity and that all legal and regulatory requirements are satisfied.
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Generally, U.S. Food and Drug Administration (FDA) SOP requirements are concerned with ensuring quality within a company. Using proper SOPs helps companies comply with FDA requirements, and the SOPs themselves are used by the FDA to assess whether companies are compliant. The SOPs needed by a company are partially determined by what industry that company operates in. For example, a pharma company will need different SOPs than a food manufacturing company.
Pharmaceutical companies have to operate under the strict regulations put forth by the FDA, or other regulatory bodies. That makes the pharma SOP guidelines stricter than they would be in other industries. One example is that pharma companies must have written SOPs showing that their products have the identity, strength, quality, and purity that the company claims.
A well-crafted SOP offers clear direction and instruction specifically designed to avoid deviations—an absolute necessity for maintaining compliance and delivering quality products.
Describe the rationale and intent of the SOP in a couple of sentences.
Identify who and what the SOP applies to and include what is considered outside the scope of the SOP.
Define terms used in the SOP. Make sure these definitions are consistent across your company’s SOPs
List which roles are affected by the SOP. If too many roles are involved in a single SOP, it may be necessary to break the procedure down into multiple SOPs.
Write a detailed description of the steps involved in this process. Be sure to only include steps that are a part of the process and ensure that any steps required by regulations are included.
Keep track of changes made to the procedure and why those changes were made.
The MasterControl Quality Excellence Solution™ functions as an SOP writing software for companies trying to create, improve, and organize their SOPs. With the templates provided by MasterControl, writing the initial SOP is comparatively easy. Managing and revising the SOPs after the fact is difficult. As a document control system, this solution keeps all SOPs in a centralized location and tracks revisions automatically.Learn More about Our Quality Excellence Solution