By Everett Larsen

Regulated industries — such as pharmaceuticals, brewing and distilling, or nuclear power — present special challenges for technical writers and information developers. These regulated industries have conflicting usability and compliance requirements, and within all of them the Standard Operating Procedure (SOP) is the primary document that provides both instructional content and regulatory compliance.

Successful SOP writing comes from balancing the competing needs of two groups of users: the regulatory community and the manufacturing process operators. A clear, concise SOP that fully focused on the information needs of its process users would almost certainly generate violations or warnings from its regulators. Conversely, an SOP that fully met a complete set of regulatory guidelines would be almost unreadable by anyone but a regulator, and would be useless for guiding any manufacturing process.

The larger world of technical writing is focused on the goal of communicating highly technical information to an audience that is informed to varying degrees, and in need of current, specific, and functional information. Software development, telecommunications, and health care all depend on the skills of technical writers to provide users of their products and services with information and instruction. The needs of users for clear and usable written information is always paramount.

An SOP, on the other hand, is a process document that is legally required by regulations that govern manufacturing and operations in regulated industries. The term SOP is often used to refer to instructional documents that are to be followed closely.

For example, in the pharmaceutical industry, Current Good Manufacturing Practice (CGMP, sometimes shortened to GMP) is the regulatory structure that mandates a documentation framework for pharmaceutical manufacturing. In Canada, Health Canada is the responsible regulatory agency, operating through the Health Products and Food Branch Inspectorate. In the United States, the Food and Drug Administration (FDA) interprets and enforces the CGMP regulations.

Regulatory documents for pharmaceutical manufacturing are published in an integrated and coherent Quality System, which ensures that a drug product meets all legal requirements for identity, strength, quality, purity, and effectiveness. An effective Quality System is a structured set of standards, company policies, and operating procedures coordinated by a state, provincial, and/or national regulatory agency.

Documents in regulated industries have the force of law, and are subject at all times to audit by industry regulators. A key assumption that is followed by regulatory agencies is “if it is not written down, it didn’t happen.” The job of a regulator is to review written procedures and ongoing manufacturing process data, and to evaluate how well these procedures and data comply with regulations that control the activities of an industry.

SOPs are written instructions, and they must describe and specify all steps required to successfully perform a manufacturing activity. Collectively, SOPs, job aids and forms together define a document infrastructure that describes a company’s activities completely. Nothing is left to chance, and nothing done under procedural control is unexpected. In fact, emergency response SOPs will instruct personnel on what to do if something unexpected should occur!

Despite their role as process controls, SOPs are living documents, and their content is not carved in stone. For the past 60 years, good document practice in the pharmaceutical industry has required a formal periodic review of all procedures every two years. The assumption is that within a two-year time span, the work process described by an SOP may well change. If equipment, ingredients, steps or responsibilities in the process have changed, then the SOP must be revised to accurately capture the current process.

A typical manufacturing plant in the pharmaceutical sector maintains somewhere between 2,000 to 4,000 GMP-related written instructions. Given the expectation that each written instruction will be reviewed every two years, a considerable amount of effort is required to maintain a compliant library of procedures.

The audience for SOPs includes members of manufacturing teams, quality control personnel, laboratory scientists, mid- and upper-level management; but the SOP audience also, and most importantly, includes representatives of regulatory agencies. These regulators will audit a manufacturer to review procedures, and assess the firm’s level of compliance to current regulations. Again, “if it is not written down, it didn’t happen.” If they find document discrepancies or deficiencies during an audit, regulators will look deeper into a company’s production activities. This investigation can lead to enforcement actions against a company that can even include court-supervised remediation.

Writers interested in working in regulated industries may face some adjustment to their assumptions and work practices to be successful. In a regulated industry, the emphasis is on compliance with the stringent requirements of the industry’s regulations and regulators. There is a ongoing dynamic tension between the competing requirements for clear, usable and unambiguous manufacturing instructions, and the need at the same time to demonstrate thoroughly to industry regulators that the instructional document complies with all the relevant regulatory requirements. For writers who accept this challenge, there is a range of well-paid, fast-paced and always interesting work.

Everett Larsen is a Senior Documentation Specialist at Wyeth Pharmaceuticals in Rouses Point, New York, and is also the Treasurer of STC Montreal.