The Mighty SOP

A document frequently referred to is the SOP (Standard Operating Procedure). The term SOP is somewhat ambiguous, in that various people and groups use different interpretations. The brief discussion about document classification that follows is intended to help clarify Drumbeat Dimensions, Inc. use of the term.

The SOP is one of the essential documents for establishing and implementing a Quality System. The SOP ensures a consistent application of the activities and tasks aligned with the Quality System.

All GMP-related documents can be categorized into three types: Instructions, Events, and Reviews (R.F. Tetzlaff). SOPs fall into the Instructions category. Instructions can be further broken down into template and nontemplate documents. A template instruction is one that lends itself to a standardized set requiring a special format, such as calibration directions, analytical test methods, or equipment cleaning procedures. A nontemplate instruction is one that does not lend itself to a stereotyped set.

The following table provides an overview of all the categories:

Types, Classes, and Kinds of Regulatory Documents

In Dynamic DRUMBEAT^® Products, the terms SOP and Policies have specific meanings. SOP is used exclusively to refer to an instruction that officially describes how a policy is to be followed or an activity is to be executed. This description matches the intended definition of the document “written procedures” most frequently mentioned in the GMPs.

Policies are nontemplate instructions. Policies describe what is to be accomplished (but not how to accomplish it), and are indexed and analyzed in the same manner as are SOPs in the DRUMBEAT^® system. Although the number of policies varies considerably from one firm to another (some firms have no policies), policies collectively usually represent a minor part of the total document inventory.

Most GMP regulations require approximately 120 to 130 different procedural subjects to be addressed. Only 15 to 20 of those subjects are potential template instructions; the rest are nontemplate SOPs and policies. A typical mature manufacturing plant will often maintain 2,000 to 4,000 different GMP-related written instructions, of which approximately 200 to 300 are nontemplate SOPs, with the balance of 90 percent or more often consisting of template instructions. All template instructions in a set must have similar format and authorship style, and must address the same general subject, such as “analytical test methods” or “instrument calibration”. Often all template instructions in a set will be from the same department. Since it is expected that flaws and attributes will be uniform across the set; such uniformity means that quality analysis of a representative sampling will often be sufficient to determine how a whole set of template instructions should be upgraded.

Whereas all template instructions in a set address the same subject, nontemplate SOPs and policies each tend to address a different subject. Hence, DRUMBEAT^® tools are used to examine every nontemplate SOP to determine what needs to be upgraded, if anything.

Event-type documents (e.g., laboratory records) and review-type documents (e.g., record reviews) can also be GMP-related, and each is addressed by at least one SOP requirement. Events and reviews are thus covered by DRUMBEAT^® analyses of relevant SOPs.