Standard Operating Procedures (SOPs) Preparation

In the preparation of SOPs there are often higher levels of documents that control the functionality of the various systems and operations. At a corporate level there are the corporate policies. These are general documents that set a goal for all plant or corporate functions. Below these policies are the standards. These are usually prepared at the site level so that each facility (assuming more than one site) applies the policies to their particular products or environmental conditions. From these standards the SOPs are prepared. SOPs are documents that inform the process operators, maintenance staff, and others about what has to be done and how it is to be done. For example, there should be an SOP for how to prepare an SOP, or an SOP on how to execute a process validation protocol. In some cases the SOPs are further subdivided into work orders which provide more specific information, for example, how to disassemble a particular process piece of equipment for cleaning.

An SOP should be easy to follow and be specific for the particular function. All documents (SOPs, protocols, etc.) should be easy to follow, as this is key to having the employees meet full compliance. While the format is not a GMP item, the content is. Appendix A provides a simple example of an SOP for preparing a VMP.

There should be an SOP to explain how to operate of each piece of equipment as well as its maintenance and cleaning procedures. Other SOPs that are needed are emergency plans, backup of data, sampling, etc. Some of these SOPs become very long, thus the work orders providing the detail needed to disassemble or reassemble a unit, are important.

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