June 26, 2023
I was both excited and curious the day I started a new job in the quality affairs department of a pharmaceutical company. As usual, I attended onboarding meetings and received a training plan that contained a list of standard operating procedures (SOPs). So far, so good.
But once I looked into the company’s training documents, my excitement turned to surprise. The SOP training included more than 150 good practice (GxP) SOPs, several of them longer than 50 pages and full of undefined abbreviations and references to unincluded documents. Some SOPs described legislation but not how it translated to defined company processes. Other SOPs were job descriptions for key personnel; interesting to read, but unrelated to my area of work.
Although my experience may not have been typical, as a GxP auditor and consultant, I realized quickly that many companies have room to improve their implementation of SOP systems. That prompted me to consider deeply how to change the popular perception of SOPs from burdensome to something more positive — for both authors and users.
Process Design as Key Success Factor
Pharmaceutical legislation usually describes GxP requirements broadly. Additional regulations, directives, ordinances, and guidelines may provide further guidance for interpretation and implementation, but each organization is unique. Companies differ according to their location, size, facilities, personnel, products, and business activities.
SOPs take regulatory requirements into account, describing processes for routine organizational activities. They ensure that activity performance is controlled, reproducible, and GxP compliant. The first steps to building an SOP system are to identify recurrent activities within an organization and decide where standardized practices are needed. Process designers should use experience and expertise to develop high quality and efficient processes and tailor them to the needs and conditions of an organization, considering regulatory requirements and relevant interfaces.
Well-defined processes remove the guesswork for employees who otherwise would need to determine individually how best to perform activities and interpret, document, and communicate information. Experienced authors document designed processes in SOPs that empower employees by providing instructions. SOPs reduce ambiguity and work effort.
SOPs are integral to pharmaceutical quality systems (PQSs). An author’s skill level will affect the quality of an SOP and the ability for employees to understand, accept, and comply with the processes outlined within. It is therefore important that SOPs are unambiguous and easy to follow to prevent risk of noncompliance, which can have severe consequences. SOP writing sounds easy, but unprepared authors might encounter pitfalls. There are different ways to write an SOP, all of which can be suitable as long as the document meets important objectives. However, some recommendations always apply.
Clear Structure
SOPs should have predefined sections and subsections that make them easy to read. Authors should consider carefully how to define the scope of each SOP. For example, a sentence such as “The SOP is applicable for all personnel involved in this process,” is too broad to be beneficial. Rather, the scope should detail the respective countries, departments, areas, functions, product groups, and process steps that are affected by a specific SOP. Authors also may exclude some aspects explicitly from an SOP’s scope to prevent it from overlapping with others. A clear scope helps to ensure that a given SOP is allocated only to relevant functions.
An SOP’s process description should provide a chronological sequence of specific tasks and define the functions responsible for executing them. Activities should not be assigned to entire departments without specificity, and general functional responsibilities should be described in job descriptions rather than SOPs. It may be helpful to summarize process-specific responsibilities grouped by function in a separate section of an SOP.
Authors should maintain a history of changes within an SOP to help users understand improvements that are linked to a date of effectiveness for each version. Employees can benefit similarly from a documented history of changes during their SOP training because it enables them to focus on updated material.
Easy Readability
Easy-to-read documents help users follow the instructions contained within them. An SOP’s value extends beyond the first time a user reads it during training. Users may consult procedural documents frequently thereafter when they perform their job activities. Authors should write SOPs in a language that all potential users can understand. Alternatively, bilingual versions or translations can be used if authors specify which version is the binding one.
In general, SOPs should be short, lean, and simple. Documents longer than 10 pages are often counterproductive. To simplify long procedural documents, authors can split them into multiple SOPs or move detailed information from the SOP to an annex or work instruction. When the resulting procedures address different target groups, training requirements also could be reduced.
SOPs should use active voice and present verb tense. They also should include sufficient details about given processes. Sentences should be short and concise with unambiguous wording that is tailored to a target group. Abbreviations can be used sparingly if they are explained in a dedicated SOP section and do not compromise readability. Specific formatting decisions can improve readability. For example, authors can enhance SOPs through skillful use of subtitles, line spacing, highlighting, tables, graphics, flow charts, and other visualizations. Documents must prevent redundancies and overlaps with other instructional materials. Work at interfaces to other functions should be described precisely.
Annexes and References
SOP authors can write annexes that contain additional information and details about a process. Annexes can include forms that help employees to document the tasks they perform. Such annexes should be listed in an associated SOP so that the relationship between the documents is obvious. That helps to track annexes when document management systems generate consecutive document IDs that do not show a relationship between those documents. Annexes should have version controls that are independent from their related SOPs to make them easier to update separately. For transparency, SOPs should provide a list of references to other documents mentioned in the text of a procedure.
Maintaining Information
An author should specify job functions or positions in an SOP rather than the names and personal information of specific employees. Phone numbers and email addresses are subject to frequent change and should be excluded from SOPs. Alternatively, such information could be provided as an annex to be updated independently. Forms of external origin (for example, those published on an authority website) should be referenced in an SOP by providing a source link rather than attaching the form as an appendix. Giving a citation prevents the need to replace such forms with recently updated versions, which might be overlooked.
An SOP is worthless if it is out of date. Stakeholders should perform periodic reviews at defined intervals to ensure that SOPs remain accurate, current, and fitting. SOPs always should be updated as needed, such as when changes occur to processes, organizations, or regulatory requirements. The protocol for changing SOPs should itself be detailed in an SOP describing an SOP’s life cycle.
If the need to incorporate new requirements into an SOP system arises, writing a new SOP is often easier than is integrating new information into an existing document. However, many such incidents over time can result in procedural overlaps or lead to an overabundance of SOPs. An external consultant can offer remediation to help streamline exaggerated SOP systems.
SOP Training
Involved employees must receive training in SOPs, work instructions, and annexes before they become effective to promote regulatory compliance. Training can be carried out in a remote or onsite classroom with an instructor, as a training module within an electronic training system, or through self-training. The best choice for training depends on the target group, the complexity of a document’s content, and that document’s life cycle — for example, whether the document is new or only updated.
SOP training requires time and can quickly overburden employees. To prevent frustration and training noncompliance, authors should define the functions served by specific training. Only employees who perform activities described in a given procedure should be trained in it, and training effectiveness should be assessed subsequently. In addition, documents can be distributed to defined recipients who have a relevant interest in that information. An up-to-date training matrix provides transparency on training requirements and groups with special interest.
Choosing Benefit over Burden
SOPs can be beneficial or burdensome to an organization. To ensure the former outcome, it is important to have an excellent process design and an author who is experienced in SOP writing. Those factors will result in well-structured, understandable, easy to read, and focused descriptions for routine processes.
A clear scope, a well-defined target group, and a lean description of tasks and responsibilities in a process flow helps to foster GxP compliance. Well-written SOPs reduce employee workload during routine business and limit the burden of lengthy or unnecessary SOP training. SOP systems require continuous maintenance to stay lean and keep processes up to date. Because process design and SOP writing require profound expertise and experience, external support can benefit many biopharmaceutical companies.
Corresponding author Annegret Blum is director and principal consultant for quality management and compliance at PharmaLex GmbH, Baseler Str. 7, 61352 Bad Homburg vor der Höhe, Germany; [email protected].
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