Introduction
Standard Operating Procedures (SOPs) are mandatory requirements in pharmaceutical and medical device companies. But why are SOPs truly necessary in the first place?
Historical Context of Japanese Manufacturing Excellence
Japanese manufacturing has historically excelled at teamwork, with workers collaborating to bring high-quality products to market. In this traditional approach, design and manufacturing often proceeded smoothly even without extensive written procedures. Workers relied on their expertise, experience, and mutual support to maintain quality standards.
However, it is important to recognize that individuals who cannot perform their work without constantly referring to procedural documents may not possess the fundamental competencies required for design, manufacturing, and related operations. For example, no one drives an automobile while reading a driver’s manual. Drivers are expected to have memorized the rules of operation, traffic regulations, and road signs before getting behind the wheel.
The Primary Purpose of SOPs: Management and Control
If experienced professionals can work without constantly consulting procedures, what then is the fundamental purpose of SOPs? The answer is straightforward: SOPs exist for management and control purposes.
Western organizational cultures, unlike Japanese approaches, typically follow a top-down management structure. In these systems, managers must actively verify and control that their subordinates’ work is being performed appropriately and in compliance with established standards. SOPs serve as the reference standard for this verification process.
During internal audits, external audits, and regulatory inspections, auditors and inspectors use SOPs to verify two critical aspects:
- Whether the company complies with applicable laws and regulations
- Whether records are properly created in accordance with established procedures
Regulatory Context and Requirements
Pharmaceutical Industry
Under current Good Manufacturing Practice (cGMP) regulations, specifically FDA 21 CFR Part 211, pharmaceutical manufacturers must establish written procedures for production and process control activities. The U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and World Health Organization (WHO) all require pharmaceutical companies to maintain comprehensive SOP systems as part of their quality management frameworks.
EU GMP guidelines (EudraLex Volume 4, Chapter 4) define documentation as a core component of the Pharmaceutical Quality System and expect clear instructions and complete records for all GMP activities. The International Council for Harmonisation (ICH) Q10 guideline further emphasizes the importance of documented procedures in pharmaceutical quality systems.
Medical Device Industry
For medical device manufacturers, ISO 13485:2016 serves as the international standard for quality management systems. This standard, last reviewed and confirmed in 2025, establishes comprehensive documentation requirements for all processes that impact device safety and effectiveness.
A significant regulatory development occurred on February 2, 2024, when the FDA published the Quality Management System Regulation (QMSR) final rule. This regulation replaces the long-standing Quality System Regulation (QSR) under 21 CFR Part 820 and incorporates ISO 13485:2016 by reference. The QMSR becomes effective on February 2, 2026, harmonizing U.S. medical device quality requirements with internationally recognized standards.
This harmonization means that compliance with ISO 13485:2016 will become the baseline requirement for legally producing and selling medical devices in the United States. The regulation emphasizes risk-based approaches to quality management, enhanced traceability, and more rigorous documentation requirements throughout the device lifecycle.
Training Requirements for SOPs
When SOPs are initially issued or revised, proper training is mandatory. However, simply explaining the SOP document itself is insufficient, particularly for new employees or personnel transferring from other departments.
Why SOPs Alone Are Inadequate for Training
SOPs are written for individuals who already possess foundational knowledge and understanding of the relevant processes. They assume a baseline level of competency and familiarity with the work environment. For personnel new to a role or process, SOPs alone cannot provide the comprehensive education needed to build true understanding.
The Need for Dedicated Training Materials
For new employees and transferring personnel, organizations must develop separate, comprehensive training materials that build understanding from the ground up. These training materials should:
- Explain fundamental concepts and principles
- Provide context for why procedures are structured in specific ways
- Include practical examples and scenarios
- Address common questions and potential challenges
- Connect individual procedures to broader quality objectives
Regulatory guidelines, including FDA 21 CFR 211.25(a) and ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, Section 3.12), explicitly require that personnel receive training appropriate to their job responsibilities. Training must be well-documented, thorough, and ongoing, with programs reviewed at least annually.
Inadequate Training Practices
Unfortunately, some companies take an inadequate approach to SOP training. They simply publish new or revised SOPs and expect employees to review them independently, often with minimal verification of understanding. This “self-study” approach, which in practice may amount to little more than employees briefly scanning the document, is wholly insufficient and represents poor quality management practice.
Effective training programs must include:
- Structured instruction delivered by qualified trainers
- Interactive elements that verify understanding
- Practical exercises or demonstrations where applicable
- Assessment of competency before allowing independent work
- Documentation of training completion and comprehension
Training documentation must include, at minimum, a sign-in sheet with each person’s name and signature, the course name and number, date of the session, and the instructor’s name and signature. Quality Assurance must approve training programs to ensure completeness, accuracy, relevance, and meaningfulness of topics.
Optimal SOP Design Principles
Based on the fundamental purpose of SOPs—to enable management and verification—this author advocates that SOPs should document the minimum requirements necessary for regulatory compliance in an extremely simple and concise manner.
Common Pitfalls in SOP Writing
Many companies fall into problematic practices when creating SOPs:
Excessive Detail: Some organizations include far too much information in their SOPs, attempting to cover every possible scenario, exception, and contingency. While this may seem thorough, it actually undermines the primary purpose of the SOP. When procedures become overly complex and detailed, it becomes difficult for managers and auditors to verify whether work has been performed appropriately.
Inclusion of Exception Cases: Documenting numerous exception cases and special circumstances within SOPs creates confusion and makes compliance verification challenging. Exception handling should follow a different approach, as discussed below.
Over-documentation: When SOPs contain excessive detail, they become unwieldy documents that are difficult to maintain, train on, and verify against. This defeats their purpose as management tools.
The Distinction Between SOPs and Work Instructions
It is important to recognize the hierarchical relationship between different types of documentation in a GMP environment:
SOPs (Standard Operating Procedures): Define how GMP-relevant processes operate from start to finish, including responsibilities, inputs, outputs, and key controls that protect product quality and patient safety. SOPs remain at the process level and point to specific tasks that require more detailed instructions.
Work Instructions (WIs): Provide step-by-step, task-level guidance for specific operations. Work instructions contain the detailed information needed for consistent execution of individual tasks.
Regulatory authorities (FDA 21 CFR 211, EU GMP Chapter 4) require written procedures with sufficient detail for consistent execution, but they rarely specify “Work Instruction” explicitly. Many companies meet regulatory expectations by combining process-level SOPs with task-level work instructions.
The Critical Role of Forms and Templates
Given the principle that workers should not need to constantly consult SOPs during actual operations, what ensures that work is performed correctly and without errors? The answer lies in well-designed forms and templates.
Forms as Procedural Guides
As previously noted, workers perform their tasks without referring to SOPs during execution. However, they invariably use forms and templates as they work. Forms serve as both operational guides and documentation tools.
Ideal Form Design
The ideal approach is to design forms and templates so that:
- Sequential Guidance: Items are listed in the sequence they should be performed
- Automatic Compliance: By completing the form items in order and documenting each action, the worker automatically complies with the SOP requirements
- Built-in Controls: Critical control points and quality checks are integrated into the form structure
- Exception Handling: When detailed instructions or exception cases are anticipated, they should be incorporated into the form design rather than the SOP itself
Forms as Integral Components of SOPs
It is essential to emphasize that forms and templates are integral parts of the SOP system, not separate or supplementary documents. Well-designed forms effectively translate SOP requirements into practical, executable workflows.
This approach offers several advantages:
- Workers can focus on performing quality work rather than interpreting procedures
- Compliance verification becomes straightforward for managers and auditors
- Training can focus on the work itself rather than memorizing procedures
- Changes to detailed execution can often be managed through form revisions rather than SOP revisions
- The risk of procedural errors is reduced through structured data capture
Quality Management System Integration
Modern pharmaceutical and medical device companies increasingly utilize digital Quality Management System (QMS) software platforms to manage their complete SOP lifecycle. Systems such as SimplerQMS, Greenlight Guru, and similar platforms provide:
- Automated document control with version management
- Electronic approval workflows compliant with FDA 21 CFR Part 11 and EU Annex 11
- Integrated training management with competency tracking
- Change control processes that link SOP revisions to affected processes
- Complete audit trails for regulatory inspection readiness
- Automated archiving and retention management
These QMS platforms help ensure that SOPs remain current, accessible, and properly controlled throughout their lifecycle, while maintaining full traceability required by regulatory authorities.
Risk-Based Approach to SOP Management
Recent regulatory updates, particularly in ISO 13485:2016 and the FDA QMSR, emphasize risk-based approaches to quality management. This principle extends to SOP development and management:
- Focus detailed procedural controls on high-risk activities
- Apply proportionate documentation to lower-risk processes
- Regularly review SOPs to ensure they address current risks
- Update procedures when risk assessments identify new hazards
- Document risk considerations in SOP development decisions
The ICH Q9(R1) Quality Risk Management guideline provides a framework for applying risk-based thinking to pharmaceutical quality systems, including documentation practices.
Continuous Improvement and Periodic Review
SOPs must be reviewed and, if necessary, revised at regular intervals to ensure continued validity. Industry best practice and regulatory expectations typically call for SOP review at least every two to three years. If revision is not needed, the procedure must clearly document that it has been reviewed and its validity extended for another period.
Reviews should consider:
- Changes in regulatory requirements or guidance
- Technological advances and new equipment
- Process improvements identified through continuous improvement programs
- Feedback from users about clarity and effectiveness
- Deviations and non-conformances that may indicate procedural gaps
- Results from internal and external audits
The Cultural Dimension: Building a Quality Mindset
Beyond their regulatory function, well-designed SOPs contribute to building a quality-oriented organizational culture. When SOPs are:
- Clear and practical rather than bureaucratic
- Integrated with useful forms and tools
- Supported by meaningful training
- Regularly reviewed and improved based on user feedback
They help create an environment where quality is everyone’s responsibility and compliance is achieved through understanding rather than blind adherence.
Conclusion
SOPs are mandatory in pharmaceutical and medical device companies, but their purpose extends beyond mere regulatory compliance. They serve as fundamental management tools that enable verification, control, and continuous improvement of quality-critical processes.
For SOPs to fulfill their intended purpose effectively, organizations must:
- Keep SOPs concise and focused on minimum regulatory requirements
- Develop comprehensive training materials separate from SOPs themselves
- Design forms and templates that guide work execution and automatically ensure compliance
- Recognize forms as integral components of the SOP system
- Implement proper training programs with verified comprehension
- Utilize appropriate QMS software to manage the complete SOP lifecycle
- Apply risk-based thinking to determine appropriate levels of procedural detail
- Regularly review and update procedures to maintain relevance and effectiveness
By following these principles, companies can create SOP systems that support both regulatory compliance and operational excellence, ultimately serving the fundamental goal of delivering safe, effective products to patients and users.
Regulatory References
This article reflects requirements from the following current regulations and standards:
- FDA 21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
- FDA 21 CFR Part 820: Quality System Regulation (being replaced by QMSR effective February 2, 2026)
- FDA Quality Management System Regulation (QMSR), Final Rule (February 2, 2024)
- ISO 13485:2016: Medical devices — Quality management systems — Requirements for regulatory purposes (confirmed 2025)
- EU GMP EudraLex Volume 4: Good Manufacturing Practice for Medicinal Products
- ICH Q10: Pharmaceutical Quality System
- ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- ICH Q9(R1): Quality Risk Management
- WHO Good Manufacturing Practices Guidelines
- FDA 21 CFR Part 11: Electronic Records; Electronic Signatures
- EU Annex 11: Computerised Systems
- IEC 62304: Medical device software — Software life cycle processes
- ISO 14971: Medical devices — Application of risk management to medical devices
Note: Regulatory requirements evolve continuously. Organizations should consult current regulatory guidance and maintain awareness of updates to applicable standards and regulations.
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