Analyzing the architecture of effective operating procedures


For those of us who operate in the heavily regulated pharmaceutical industry, it is axiomatic to state that we abide by procedures which describe how to perform the routine tasks and activities that must be performed for any given process or process phase. A colleague of mine has estimated that some large multi-national firms may have in excess of 1,000 standard operating procedures (SOPs) that govern pharmaceutical operations in all their glorious detail. Since the Food and Drug Administration focuses heavily on the adequacy and thoroughness of a firm`s documentation system in assessing relative compliance, the process of writing SOPs should not be an art form. This column will present a suggested approach for developing SOPs.

Before we describe the architecture of a standard procedure, management must be sure that the procedure in question is in complete alignment with overarching company policy. This will prevent a decay in expectations between senior management and the operating unit. Of course, the company policies themselves must be in alignment with overarching local, state, national and international regulations. Note that the construction of policies is different than the construction of lower level procedures.

The first step

Let`s return to the operating unit. For starters, the plant should have an “SOP on SOPs.” This predicate SOP lays out the rules for developing SOPs in terms of structure. The structure (or format) of each SOP should be standardized. Each SOP should therefore have the following components: heading, purpose, scope, definitions, safety, background, materials, procedure (process) description, interpretation of data, references and appendix.

The heading should be composed of the procedure number, title of the procedure, effective (implementation) date, superseded date, originating department and page number. The heading should also have space requiring the signature and date of the individual credited as the preparer of the document as well as for the approvals and dates from the various departments. This information should hopefully fit in the upper third of the title page. Alternatively, the signatures could be placed at the end of the document. The procedure title, procedure number, effective date and consecutive page number should be listed at the top of every page of the procedure.

The purpose section specifies why the procedure was written. It should be succinctly written so that there is no ambiguity about what the procedure is designed to accomplish. Make sure that the title of the procedure is in alignment with the intended purpose for writing the procedure. Too many times, I have seen purpose statements at variance with the title of the procedure itself. This is particularly confusing and frustrating for those who review the adequacy of these documents. The verbiage in this section, as throughout the other sections of the procedure, should be (largely) written in the future tense.

The scope section should describe what the procedural “boundaries” shall be. In essence, the scope specifies what the procedure covers. Occasionally, firms will write specific statements about what the procedure does not cover along with what the procedure does cover. If a procedure describes a complex process or system, then it might be a good idea to have this “split” written into the scope. Otherwise, it is not necessary.

The definitions section is self- explanatory. Technical terms and any other key terms integral to the topic should be clearly and accurately defined. I have noted that practitioners in the industry have a tendency to use the terms “sanitization,” “disinfection” and “sterilization” interchangeably. These terms mean different things from a tech nical perspective.

The safety section should indicate what precautions are required to be taken or what procedures must be reviewed to assure that the respective procedural tasks are performed properly and without injury to personnel (e.g., pulling of compressed gases).

The background (or general) section is intended to provide perspective, and often, some educational information intended to help the user gain a better understanding as to the currency and salience of the particular procedure. Not all firms write background sections into their procedures. My view is that procedures should contain such sections so that the user or auditor can better appreciate the foundation for why the procedure was written in the first place.

The materials section may not always be applicable. In laboratory settings, however, it is always applicable. All materials, whether chemical, biological or physical laboratory reagents, equipment or disposable supplies, should be listed. In the case of biological organisms, it is crucial that each strain be exactly identified (e.g., Escherichia coli ATCC 8739 and not Escherichia coli). Unique strains of the same organism act differently.

Writing the procedures section

The procedure section is the most important section because it is the road map, and tells the user how to perform the relevant tasks. In many cases, the procedure section will be describing a process that the individual is required to perform. The description of the process should be concise and exact. The idea is to standardize the way the recurring task is handled, so that every time it is done, it is done effectively.

Any trained individual should be able to properly execute the procedure if it is clearly written. It is best to write the steps using the Dewey decimal system so that it is easy to follow and perform the successive steps. Writing tasks in superfluous prose or in a general narrative style is a no-no. There should be a bold heading that precedes the listing of the various tasks or process steps that are to be performed. If the process is composed of various phases, then there should be headings for each phase of the process. Again, the “process description” embodied in the procedure section should be overwhelmingly clear so that the execution of the procedure can be performed in a consistent manner. A client once told me, presumably with a straight face, that he was not a proponent of such a precise style. Instead, he favored a less precise style of writing, leaving it to the “creativity” of his analysts in regard to the execution of the procedure. The manufacturing environment is not intended to operate like Hollywood. We are not engaged in the “creative process.” We are instead interested in performing a series of routine activities in accordance with clearly and precisely written procedures. I call it conveyor-belt science.

A final word on the procedure section. Throughout the description of the process, there must be a listing of the responsible parties required to actually perform the task. Some firms line up the responsible parties on the left side of the page, and the process description flows in sequence on the right side of the page. Others imbed the responsible party within the process description itself.

The final sections

The interpretation of the data section is again self-explanatory. This section may either list the testing or process specifications or refer the user to other official and controlled documents for specification information and guidance. Additionally, this section should provide instructions in the event, for example, that discrepant results are obtained (e.g., notification to the supervisor, consulting relevant SOP dealing with the handling and the investigation of discrepant data).

The references section should contain a listing of pertinent documents that relate to the procedure at hand. These listings should minimally indicate the name, identification number and effective date of each document. Since many processes are interdepartmental in nature, for example, the pulling and testing of a raw material or finished product, it is important that the transaction or hand-off between the departments be understood. Cross-referencing other procedures is a good way to do this. Companies are typically structured along departmental lines (e.g., manufacturing, QC, QA). However the basic business processes, such as commercial product supply that drives pharmaceutical operations, cross departmental lines. So, the firm must be sure that there are no process gaps missing in the various procedures written by the several departments. A good example is the management of samples in a plant. It is crucial to have a robust change control system for maintaining documentation control. Keywords can be a big help in this regard.

The appendix section would typically contain supporting documents or tables describing or referring to some aspect of the procedure. For example, a tabular description of the locations, physical descriptions of the ports and frequency of pulling water samples would logically fit into this section. Additionally, in this section, it would be appropriate to denote the changes made to each successive version of the procedure as part of the documentation review process. Some firms have instead a dedicated section for recording the historical changes to procedures.

Getting the green light

Once the procedure is written, and then reviewed and approved by management, applicable personnel must be appropriately trained on the procedure before it is officially implemented. Once the training has been performed, documented and archived, then the procedure is officially in effect. This is what is meant by the “effective date.”

Well-written SOPs that accurately de scribe the various processes and tasks to be performed are a necessary element in a sound functional (manufacturing) strategy. This element is an enabler for achieving static or in-place compliance. The proper execution of these SOPs by trained personnel is an enabler for achieving, more importantly, dynamic or in-use compliance. Well- written SOPs also contribute to continuous improvement efforts by clearly defining and mapping the business process or activity. Moral: When operating in a regulated setting, abide by the “written tradition.” The “oral tradition” has a way of leading to folklore.

Richard Prince Ph.D., is president of Richard Prince Associates, Inc. (Short Hills, NJ), a pharmaceutical-based consultancy. Prince has been providing contract testing and consulting services to the pharmaceutical and allied industries for 12 years. He can be reached at (973) 564-8565 or E-mail: [email protected].


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