Quality
It’s important to set up guidelines for those SOPs before they are written to ensure uniformity and that all legal and regulatory compliance 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.
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.
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