Issues with Out-of-Field Recording in Pharmaceutical Manufacturing

Introduction

In pharmaceutical manufacturing, the Manufacturing Record (Batch Record) serves as critically important documentation that provides evidence of product quality. This record demonstrates that a pharmaceutical product has been appropriately manufactured according to established procedures and plays a central role in GMP (Good Manufacturing Practice). However, a problem known as “out-of-field recording” frequently occurs at manufacturing sites, becoming a serious concern from a quality assurance perspective.

What is Out-of-Field Recording?

Out-of-field recording refers to the practice of recording information in locations outside of the pre-designated entry fields in manufacturing records, such as in margins, on the reverse side of pages, or other unintended areas. Examples include:

• Writing supplementary information beside measurement value entry fields
• Making notes in the margins or on the reverse side of pages
• Attaching sticky notes
• Recording additional explanations in non-designated locations

While these actions may appear trivial at first glance, they can cause serious problems that cannot be overlooked in pharmaceutical quality control.

Problems Caused by Out-of-Field Recording

1. Compromise of Record Integrity and Reliability

Pharmaceutical manufacturing records are required to completely and accurately document the entire manufacturing process. Out-of-field recording constitutes information outside the official recording system and creates the following problems:

Questions regarding Data Integrity: Out-of-field recording is not included in the official recording system, thereby undermining the reliability of the entire record.

Incomplete Audit Trail: It becomes difficult to trace when, by whom, and why the information was recorded.

Lack of Record Consistency: Deviation from standardized recording methods results in loss of consistency among records.

2. Regulatory Compliance Violations

Pharmaceutical manufacturing is conducted under strict regulations, and the following regulatory problems arise:

Violations of PIC/S GMP Guidelines: Deviation from clear rules regarding records. The PIC/S GMP Guide (PE 009-17, 2022) specifically requires in Chapter 4 that “any alteration made to the entry on a document should be signed and dated; the alteration should permit the reading of the original information.”

Potential for Inspection Findings: This can become a critical observation during regulatory authority inspections. According to FDA guidance on Data Integrity (December 2018), all data must be ALCOA+ compliant, and out-of-field recording fundamentally violates these principles.

Risk of Product Release Delays: Delays in product release approval due to documentation deficiencies.

Warning Letters and Regulatory Actions: The FDA and other regulatory agencies have issued Warning Letters to pharmaceutical manufacturers for data integrity violations that included improper documentation practices.

3. Information Interpretation and Communication Issues

Information recorded out-of-field causes the following interpretational problems:

Information Oversight: Because it exists outside official entry fields, important information may be overlooked.

Misunderstanding of Intent: The reason why such information was recorded often becomes unclear.

Uncertain Information Transfer: Information transfer to subsequent processes or quality assurance departments becomes unreliable.

Legal and Evidentiary Concerns: In cases of product recalls or litigation, out-of-field records may be challenged regarding their validity and timing of creation.

Root Causes of Out-of-Field Recording

The main causes of out-of-field recording are as follows:

1. Deficiencies in Record Form Design

Insufficient Entry Fields: Lack of appropriate space to record necessary information (incomplete format).

Inadequate Response to Unexpected Situations: Recording methods for non-standard situations have not been established.

Poor Usability Design: Record form design that does not consider the actual workflow at the manufacturing site.

Lack of Continuous Improvement: Failure to update forms based on accumulated experience and changing process requirements.

2. Insufficient Education and Training

Lack of Understanding of GMP Documentation Importance: Insufficient understanding of the importance of records and appropriate recording methods.

Lack of Knowledge about Proper Deviation Management Procedures: Inadequate education on correct responses when unexpected situations occur.

Immature “Recording Culture”: Appropriate recording culture has not been cultivated organizationally.

Gap Between Theory and Practice: Training that does not adequately address real-world scenarios encountered on the manufacturing floor.

3. Process and Procedure Issues

Complexity of Deviation Management System: The official procedures are too complex, causing site personnel to resort to simplified methods.

Time Constraints: Production schedule pressures create psychological pressure to skip formal procedures.

Rigid Change Control Procedures: System difficulties in rapidly revising record forms.

Organizational Silos: Insufficient communication between production, quality assurance, and quality control departments regarding documentation needs.

Strategies to Address Out-of-Field Recording Issues

1. Optimization of Record Form Design

Design Considering Usability: Easy-to-use format design incorporating feedback from site workers through Quality by Design (QbD) principles.

Establishment of Fields for Predictable Deviations: Advance preparation of entry fields to accommodate frequently occurring deviations and exceptional circumstances.

Consideration of Electronic Record System Implementation: Transition to flexible recording systems that transcend paper-based constraints. Electronic Batch Records (EBR) offer enhanced traceability, reduced errors, and improved data integrity when properly implemented according to FDA 21 CFR Part 11 requirements.

Iterative Design Process: Regular review and revision of forms based on user feedback and actual usage patterns.

Risk-Based Approach: Prioritize improvements to critical process steps and high-risk areas.

2. Strengthening Education and Training

Education on GMP Recording Principles: Thorough implementation of ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available). These principles, emphasized in both FDA and EMA guidance, form the foundation of data integrity.

Training on Appropriate Deviation Management Procedures: Acquisition of correct response methods when unexpected situations occur.

Practical Education Using Case Studies: Explanation of problems and correct responses using actual out-of-field recording cases.

Role-Playing Exercises: Simulation of challenging documentation scenarios to build confidence and competence.

Continuous Learning Culture: Regular refresher training and updates on regulatory changes and best practices.

3. Process Improvement

Simplification of Deviation and Change Control Processes: Reducing site burden while maintaining necessary control levels. Implementing risk-based approaches that differentiate between minor and major changes.

Regular Review and Revision of Record Forms: Continuous improvement based on actual usage conditions.

Strengthening Collaboration Between Site and Quality Assurance Departments: Promoting inter-departmental communication for early problem detection and resolution.

Implementation of Quality Metrics: Establishing key performance indicators (KPIs) to monitor documentation quality and identify trends.

Root Cause Analysis: Systematic investigation of out-of-field recording incidents to identify and address underlying systemic issues.

4. Technology and Digitalization

Electronic Signature Integration: Implementing compliant electronic signature systems that provide clear audit trails.

Real-Time Data Capture: Utilizing automated data acquisition systems to reduce manual recording requirements.

Mobile Technology: Enabling documentation through tablets or mobile devices with proper controls.

Data Integrity Tools: Employing software solutions that detect and prevent data integrity violations.

Regulatory Landscape and International Standards

The issue of out-of-field recording must be understood within the context of evolving global regulatory expectations:

Regulatory Body/Standard	Key Requirements	Relevance to Out-of-Field Recording
FDA (21 CFR Parts 210, 211)	Complete and accurate batch records; ALCOA+ principles	Out-of-field recording violates completeness and attributability requirements
PIC/S GMP Guide (PE 009-17)	All entries must be clear, legible, and indelible; alterations must be signed and dated	Informal notations undermine traceability
EMA GMP Guidelines (Annex 11)	Electronic records must ensure data integrity; audit trails required	Applies equally to paper records in principle
ICH Q7 (API GMP)	Laboratory records must be complete and accurate	Out-of-field recording in API manufacturing poses similar risks
WHO GMP Guidelines	Records should be designed to avoid errors; clear documentation required	Emphasizes proper record design to prevent improvisation
ISO 9001:2015	Documented information must be controlled and adequate	Out-of-field recording indicates inadequate documentation controls

Recent trends in regulatory enforcement show increased focus on data integrity. The FDA’s Data Integrity and Compliance with Drug CGMP guidance (December 2018) and the MHRA’s GMP Data Integrity Definitions and Guidance for Industry (March 2018, revised 2023) both emphasize that organizations must establish systems that prevent opportunities for data manipulation or informal documentation practices.

Industry Best Practices

Leading pharmaceutical companies have implemented several best practices to address this issue:

Lean Documentation Principles: Designing records that capture essential information without excessive complexity, reducing the temptation to record information informally.

Standard Work Instructions: Clear, visual instructions at workstations that guide proper documentation practices.

Quality Culture Programs: Organization-wide initiatives that emphasize the importance of data integrity and proper documentation as everyone’s responsibility.

Gemba Walks: Regular management visits to manufacturing floors to observe documentation practices in real-time and identify improvement opportunities.

Cross-Functional Documentation Review Teams: Including operators, quality professionals, and engineers in the design and continuous improvement of batch records.

The Human Factor

It is important to recognize that out-of-field recording is often not malicious but rather a symptom of systemic issues. Operators typically want to do the right thing and may resort to informal recording when:

• Official processes are too burdensome or time-consuming
• Forms do not accommodate the reality of their work
• They lack confidence in the proper procedure for unusual situations
• Time pressure creates stress that leads to shortcuts

Addressing the issue therefore requires a blame-free culture that encourages reporting of documentation challenges and focuses on system improvement rather than individual punishment. This approach aligns with modern quality culture concepts and human factors engineering principles increasingly emphasized by regulatory authorities.

Conclusion

Out-of-field recording in pharmaceutical manufacturing records, while seemingly minor, represents an important issue that cannot be overlooked from the perspectives of product quality assurance and regulatory compliance. Rather than simply prohibiting such practices by stating “do not write outside the fields,” it is essential to address the root causes of why out-of-field recording occurs.

Through optimization of record form design, appropriate education and training, and process improvements aligned with actual site conditions, we must reduce the need for out-of-field recording and cultivate an appropriate recording culture. The transition to electronic systems, where feasible, offers opportunities to fundamentally address many limitations of paper-based systems while introducing new considerations for data integrity and system validation.

It is imperative that all personnel involved in pharmaceutical manufacturing understand the importance of records and the significance of their proper management, working toward the common goal of delivering safe and effective pharmaceutical products to patients. In an era of increasing regulatory scrutiny and growing expectations for data integrity, the seemingly simple act of recording information in the proper location takes on profound significance. Organizations that address this issue systematically and thoughtfully will not only achieve regulatory compliance but will build more robust quality systems that ultimately better serve patients worldwide.

The pharmaceutical industry’s commitment to continuous improvement extends to all aspects of manufacturing, including documentation practices. By viewing out-of-field recording not as a problem to be punished but as an opportunity for system enhancement, organizations can create documentation systems that truly support high-quality manufacturing and regulatory compliance. This mindset reflects the modern understanding that quality is built into systems and processes, not merely inspected into products, and that every aspect of pharmaceutical manufacturing—including how we document our work—contributes to the ultimate goal of patient safety and therapeutic efficacy.