Standard operation procedure (SOP)
Writing a Standard Operating Procedure
Purpose:
To gain experience in documentation by writing a standard operating procedure for an New Brunswick BioFlo115 fermenter
Introduction:
Regulatory agencies suchas the Food and Drug Administration (FDA) set strict guidelines to ensure that products and services are consistently produced to guarantee safety. This is achieved through good laboratory procedures (GLPs) and/or good manufacturing procedures (GMPs). Documentation and other regulatory affairs components are very important parts of the process, especially in the quality assurance, quality control and manufacturing of pharmaceuticals.
There are several areas of FDA regulatory compliance. The first is that all equipment that is used to create, modify, maintain, archive, retrieve or distribute important data be validated. Validation should be performed prior to general use and after changing method protocols. As part of the validation process, installation, qualification, operational qualification and performance qualification are performed.
Standard operating procedures (SOPs) must be written that describe in detail how to validate, install, and operate all instruments. A SOP is a set of written instructions that document a routine or repetitive activity followed by a company/lab. Documents that describe how to perform routine tasks in a GMP environment of product development, purchasing, production, testing, maintenance, material handling, quality assurance and distribution. They contain step-by-step instructions that technicians consult daily to perform their work consistently and reliably. SOPs are required for many laboratory and manufacturing procedures including even how a company writes, issues and maintains the documents! They are a reflection of the importance the company places to ensure that they are accurate, complete and reflect current practices. Often within larger companies where there are many different laboratory groups, SOPs can repeat or even contradict each other, and the mistakes are only discovered during an audit.
A SOP for operational qualification includes a procedure that must be written so it is easily understood and is repeatable. In this exercise, you will write a quality control operational qualification SOP for the 1L Omni-Culture fermenter that will be used for the next set of laboratory exercises. Attached is an example of a SOP for the operation of a top-loading balance that will be used to prepare the fermenter media. The format of the “balance SOP” can serve as a reference. The Virtis Omni-culture manual, “Omni-Culture Fermenter and Chemostat Instruction Manual” will also be available for you to use.
Procedure
- using the following format (Format for SOP), prepare a SOP for the operation of the 1L Omni-Culture fermenter.
- Include the sections 2.0 and 3.0 that explain the calibration of the pH and temperature probes. Also, include a labeled picture of the fermenter as an attachment with impeller, baffles, headplate, pH probe, DO probe, temperature probe, vessel, air regulator, temperature/rpm display.
- The document must be in font Garamond, 10 pt size.
