Standard Operating Procedures (SOPs) are essential to your business. They explain how every job and task (i.e. receiving goods, testing materials, manufacturing products, maintaining equipment, etc.) are performed so that every person in your organization is performing each task exactly the same way. According to the Code of Federal Regulations (21 CFR 211.22(d)), all procedures must be in writing and all procedures must be followed.
In order to ensure each employee is performing each task the same way, employees must have access to your procedures.
A company recently received the following observation:
….. The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Specifically, departmental procedures are not maintained in their respective area and are not accessible to personnel for reference during receiving, label printing operations, and testing of … products. For example, all your SOPs are maintained in … (the electronic documentation system). However, personnel in the QC Laboratory, Label Printing Department, … area, and Warehouse do not have access to the … system for reference while in the respective area.
Download our SOP Template for FREE
Click here to download a copy of the Emergent Manufacturing Operations’ FDA 483 Report. This document is a guide for writing an SOP, or Standard Operating Procedure. This template helps you establish a procedure for the creation, approval, storage and distribution of standard operating procedures (SOP)
Download NowTo view more observations pertaining to standard operating procedures, refer to the following GMP Trends® Issues: 1070, 1069, 1068, and 1067.
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