Standard Operating Procedure (SOP) Guidelines

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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FDA SOP Requirements

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.

SOP Guidelines

  • Use the correct template or format: Every company should have a standard template to use for its SOPs. This helps ensure uniformity across all the documents and helps the SOP writer make sure he or she includes all necessary information.
  • Determine which standards are involved: Examine the standards that apply to your company and determine which ones affect the SOP in question. If certain sections or steps in the SOP are required by the standard, be sure to include those.
  • Talk to the employees involved: If the SOP reflects a practice that is already happening at your company, talk to the employees in charge of that task. Make sure the processes described in the SOP are what is actually carried out by employees.
  • Be concise, but thorough: Ideally, SOPs should be used by employees, but excessive text discourages some employees from reading the SOP. Be as concise as you can be without leaving anything out.
  • Review/revise the draft: Once you’ve written the SOP, have the managers and employees involved with that procedure look it over. Find out if it’s accurate and if it covers all the regulatory requirements.
  • Train employees: If the SOP is completely new or if there are new processes involved, pass it along to employees that need to be trained on it.

Pharma SOP Guidelines

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.

SOP Components

  • Purpose: Describe the rationale and intent of the SOP in a couple of sentences.
  • Scope: Identify who and what the SOP applies to and include what is considered outside the scope of the SOP.
  • Definitions: Define terms used in the SOP. Make sure these definitions are consistent across your company’s SOPs.
  • Responsibilities: 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.
  • Procedure: 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.
  • Revision History: Keep track of changes made to the procedure and why those changes were made.

MasterControl SOP Writing Software

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.

FDA and SOPs and MasterControl

Organizations all over the world use MasterControl software solutions to ensure compliance – including organizations that enforce compliance. The U.S. Food and Drug Administration (FDA) became a MasterControl customer in 2009. Since then, the FDA has expanded its use and now multiple divisions of the agency use MasterControl software solutions.