Standard Operating Procedures: Forms as Procedures

Best Practices for Documentation Hierarchy in Pharmaceutical and Medical Device Quality Management Systems

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1. Introduction and Regulatory Context

Through extensive consultation work with pharmaceutical and medical device companies, I have frequently observed organizations that include excessive detail in their Standard Operating Procedures (SOPs). Many companies also maintain an unnecessarily large number of SOPs.

This phenomenon is not merely an organizational inefficiency but can potentially conflict with current Good Manufacturing Practice (cGMP) requirements established by regulatory authorities including the U.S. Food and Drug Administration (FDA) in 21 CFR Part 820, the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP Guide, and ISO 13485:2016 for medical device quality management systems. These regulations emphasize that documentation should facilitate proper execution of standardized operations while maintaining regulatory compliance.

2. The Purpose and Scope of SOPs

SOPs are designed to document standardized operational procedures. They should establish the general framework and principles that apply consistently across operations. SOPs should not contain product-specific details or process-specific variations that differ from case to case.

The current regulatory landscape, particularly following the 2024 revision of treatment-related document handling procedures by the Japan Pharmaceutical Manufacturers Association (JPMA) and the ongoing revision of PIC/S GMP Guide Chapter 4 (Documentation) and Annex 11 (Computerized Systems) scheduled for 2025-2026 implementation, emphasizes that documentation systems must be risk-based, clear, and maintainable.

Key Principle: SOPs define “what” and “why” at a standard level; detailed procedures and forms define “how” for specific situations.

3. Recommended Documentation Hierarchy

I consistently advise that detailed specifications, product-specific information, and process-specific details should be documented in work instructions (procedures) and forms rather than in SOPs themselves. Forms, in particular, represent a formalized type of procedure document.

3.1 Three-Tier Documentation Structure

Document Level	Purpose	Content Characteristics	Examples	Revision Frequency
Level 1: SOPs	Define standard policies and high-level procedures applicable across products/processes	– General principles<br>- Responsibilities<br>- Workflow overview<br>- References to subordinate documents	– SOP for Deviation Management<br>- SOP for Document Control<br>- SOP for Change Control	Infrequent (annually or as regulations change)
Level 2: Work Instructions (Procedures)	Provide detailed, step-by-step instructions for specific operations	– Process-specific steps<br>- Parameter ranges<br>- Equipment settings<br>- In-process controls	– Manufacturing Procedure for Product X<br>- Cleaning Procedure for Equipment Y<br>- Testing Procedure for Assay Z	Moderate (when process changes)
Level 3: Forms and Templates	Guide execution and ensure documentation compliance	– Structured data capture<br>- Checklists<br>- Self-explanatory fields<br>- Built-in compliance	– Batch Production Record<br>- Deviation Report Form<br>- Equipment Cleaning Log	Frequent (as needed for improvement)

3.2 The Strategic Value of Forms

An ideal documentation system is one where completing a form necessarily results in compliance with the governing SOP. This approach aligns with modern quality management principles because personnel typically perform their work based on practical tools (forms, checklists) rather than by continuously reading procedure manuals during execution.

Analogy: Just as drivers do not read traffic regulations and driving manuals while operating a vehicle, trained personnel should be able to execute compliant work by following well-designed forms and checklists without constantly referencing the SOP.

This concept is explicitly supported by FDA 21 CFR Part 820.70, which requires “documented instructions, standard operating procedures (SOP’s), and methods that define and control the manner of production” and specifies that “criteria for workmanship shall be expressed in documented standards or by means of identified and approved representative samples.”

4. The Problem with Product-Specific and Process-Specific SOPs

If an organization creates separate SOPs for each product or for each process variation, the number of SOPs will inevitably proliferate. This proliferation creates several significant problems:

1. Loss of Standardization: The fundamental concept of a “standard” operation becomes unclear when there are dozens or hundreds of product-specific “standard” procedures.

2. Increased Maintenance Burden: More SOPs mean exponentially more documents to review, update, and control during change management.

3. Training Complexity: Personnel must be trained on numerous similar but slightly different SOPs, increasing the risk of confusion.

4. Regulatory Inspection Challenges: During inspections, demonstrating that appropriate procedures were followed becomes difficult when the procedure landscape is overly complex.

5. Deviation from International Standards: Both ISO 13485:2016 and the revised PIC/S guidance emphasize risk-based documentation that is “appropriate to the needs of the organization” rather than excessively detailed.

Best Practice: Maintain a lean set of SOPs that define standard approaches, then manage variations through work instructions and product-specific forms.

5. Visual Communication: A Powerful Tool for Error Prevention

In Japan, procedure documents are frequently written using text (prose) exclusively. However, I heard an interesting comparison from a former member of the Japan Self-Defense Forces that illustrates the power of visual communication:

In the Self-Defense Forces, when documenting how to throw a hand grenade in a manual, the instructions are typically written in text format only. In contrast, the U.S. military explains the same procedure using a four-panel comic strip without any text.

This approach serves multiple purposes beyond accommodating multinational personnel. Most importantly, it is the most effective method to prevent accidents arising from misinterpretation or misunderstanding. The principle is universal across different types of equipment – modern printers, for example, often display pictorial instructions on their screens when paper jams occur, and many machines have visual instruction labels affixed to them.

The principle: “A picture is worth a thousand words” (百聞は一見にしかず – “hearing a hundred times is not as good as seeing once”)

6. Regulatory Support for Visual Documentation

While traditional GMP regulations did not explicitly mandate visual aids in documentation, current regulatory thinking increasingly recognizes their value:

FDA 21 CFR Part 820.70(a)(5) states that “criteria for workmanship shall be expressed in documented standards or by means of identified and approved representative samples.” This implicitly recognizes that visual references can be as valid as text descriptions.

PIC/S GMP Guide Chapter 4 (revised draft 2025) emphasizes that “all documentation, whether in text, image, video, or audio form, must remain complete and readable throughout its lifecycle.” This represents a significant expansion of recognized documentation formats.

ISO 13485:2016 Section 4.2.4 requires that documents “remain legible, readily identifiable and retrievable” but does not restrict documentation to text-only formats. The accompanying guidance (ISO 13485:2016 – Medical Devices – A Practical Guide) acknowledges that visual aids can improve clarity and reduce errors.

7. Benefits of Visual Documentation for Human Error Prevention

I strongly advocate for increased use of photographs, diagrams, flowcharts, and visual aids in SOPs and work instructions. The benefits include:

7.1 Error Prevention Mechanisms

Error Type	How Visual Documentation Helps	Example Application
Inadequate Training	Provides immediate visual reference reducing dependency on memory	Connection diagrams for equipment setup
Insufficient Understanding	Clarifies complex concepts that are difficult to describe in words	3D diagrams of aseptic technique hand positions
Assumptions and Misconceptions	Shows exactly what “correct” looks like, eliminating interpretation	Before/after photos of cleaning verification
Confusion	Reduces ambiguity through clear visual differentiation	Color-coded flowcharts for different process paths

7.2 Practical Applications

Manufacturing Operations:

• Annotated photographs showing proper equipment assembly
• Visual inspection criteria with example photos of acceptable/unacceptable conditions
• Assembly sequence illustrations
• Color-coded piping and instrumentation diagrams

Quality Control:

• Comparison photographs for visual defect identification
• Illustrated laboratory technique guides
• Flowcharts for decision trees in method selection
• Visual aids for chromatogram interpretation criteria

Facility Management:

• Gowning procedure illustrations with step-by-step photographs
• Equipment cleaning visual standards
• Material flow diagrams
• Segregation and storage area maps

8. Implementation Recommendations

8.1 For Organizations Currently Over-Documenting in SOPs

1. Conduct a Documentation Audit:

   • Inventory all existing SOPs
   • Identify product-specific or process-specific content
   • Assess which details could migrate to work instructions or forms

2. Rationalize and Consolidate:

   • Merge similar SOPs into broader, principle-based documents
   • Extract specific details into work instructions
   • Design forms that guide compliance

3. Establish Clear Criteria:

   • What belongs in an SOP vs. a work instruction vs. a form?
   • Define review and approval hierarchies for each level

8.2 For Incorporating Visual Elements

1. Start with High-Risk or Complex Operations:

   • Identify operations with frequent errors or deviations
   • Assess where visual aids would have prevented past incidents

2. Use Multiple Visual Formats:

   • Photographs for showing actual conditions and equipment states
   • Diagrams for showing relationships and connections
   • Flowcharts for decision-making and branching processes
   • Tables for organizing information systematically

3. Maintain Quality Control of Visual Documents:

   • Ensure photographs are high-resolution and clearly show relevant details
   • Use consistent formatting and annotation styles
   • Version control visual documents as rigorously as text
   • Verify that images remain legible in both electronic and printed formats

4. Address Regulatory Documentation Requirements:

   • Ensure visual documents are backed up and retrievable per 21 CFR 820.180
   • Include metadata (date captured, equipment ID, location) as appropriate
   • Control changes to visual standards through the normal change control process

9. Alignment with Current Regulatory Trends

The shift toward risk-based, efficient documentation systems is evident in current regulatory developments:

2024-2025 GMP Evolution:

• PIC/S and EU GMP revisions emphasize quality risk management integrated into documentation practices
• Recognition that over-documentation can be as problematic as under-documentation
• Acceptance of diverse media formats (text, image, video, audio) as valid documentation

Data Integrity Focus:

• ALCOA++ principles (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available) apply equally to visual and textual documentation
• The revised Annex 11 (2025 draft) requires that user requirements be “traceable throughout the life-cycle,” which includes documentation formats that facilitate effective use

Human Factors Recognition:

• Regulatory bodies increasingly acknowledge that human error prevention requires documentation designed for actual human use patterns
• FDA’s emphasis on human factors engineering in medical device design extends to operational documentation

10. Conclusion

The strategic approach to documentation in pharmaceutical and medical device quality systems should recognize that:

1. SOPs should establish principles and standards, not attempt to capture every detail of every variation.

2. Forms and work instructions are where detailed compliance is executed, and well-designed forms can make SOP compliance automatic.

3. Visual documentation is not merely supplementary but can be primary, particularly for operations where seeing is more effective than reading.

4. The goal is effective control, not document volume. Regulatory compliance is achieved through appropriate documentation that facilitates correct execution, not through the sheer quantity of pages.

Organizations that maintain lean, principle-based SOPs supported by comprehensive work instructions, well-designed forms, and appropriate visual aids will find themselves better positioned for:

• Regulatory inspections
• Training effectiveness
• Error prevention
• Change management
• Operational excellence

By minimizing deviations arising from training deficiencies, understanding gaps, assumptions, and confusion—all manifestations of human error—we create quality systems that are both compliant and practical. This is the essence of modern GMP: systems designed for humans, verified by process, and assured by documentation.

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References and Regulatory Citations

1. U.S. FDA 21 CFR Part 820 – Quality System Regulation
2. PIC/S GMP Guide PE 009 (January 2017 version and 2025 draft revisions)
3. PIC/S GMP Guide Chapter 4 – Documentation (2025 draft revision)
4. PIC/S GMP Guide Annex 11 – Computerised Systems (2025 draft revision)
5. ISO 13485:2016 – Medical devices – Quality management systems – Requirements for regulatory purposes
6. ISO 13485:2016 – Medical Devices – A Practical Guide (ISO Handbook)
7. Japan Pharmaceutical Manufacturers Association (JPMA): Standard Operating Procedures for Electronic Handling of Clinical Trial Related Documents (2024 version)
8. JIS Q 13485:2018 (Japanese Industrial Standard for ISO 13485:2016)

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Document Revision History:

• Original concept article: [Date of original publication]
• Revised and enhanced version: January 2026
• Fact-checked against current regulations: January 2026
• Language: English translation with regulatory enhancements

Author’s Note: This document represents professional guidance based on extensive consulting experience in pharmaceutical and medical device quality systems, integrated with current regulatory requirements from FDA, PIC/S, ISO, and Japanese regulatory authorities. Organizations should adapt these principles to their specific operational contexts and regulatory obligations.