SOP/Template

Document Control System SOP | IVT

There is a distinct difference between a technical review of data and a release review. A technical review is that final review of all raw data, worksheets, chromatograms, calculations, etc. associated with testing to assure data integrity prior to release of the data. The release review is the review that assures results meet specifications prior to release of the product. Each review should be well-defined in SOPs.

An effective system for controlling GMP docu- mentation is perhaps the most important tool in the GMP Toolbox. Without proper document control, there is little to no chance for the proper operational control demanded by GMP.

Most GMP-compliant document control systems include at least  12 elements. Instilling these elements as standard activities defines the concept of “QA Control.” Each element is discussed in some detail below. In addition, an example SOP is attached that might serve as a model for establishing a proper GMP document control system.

Download the accompanying article, "Introduction to the Good Manufacturing Practice (GMP) Toolbox"

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