Differences Between Internal Audits and Self-Inspection

Differences Between Internal Audits and Self-Inspection

Introduction

In pharmaceutical and medical device manufacturing and quality management, organizations utilize various evaluation methods to enhance the quality of their products and services. Among these, “internal audits” and “self-inspection” are frequently mentioned terms. While these may appear similar at first glance, there are significant differences between Japan’s “self-inspection” practices and international “Self Inspection” requirements in terms of their positioning and implementation methods. This article explains the differences in these approaches and discusses the importance of meaningful quality system evaluations.

What is an Internal Audit?

An internal audit is an activity that periodically verifies compliance with Quality Management Systems (QMS) and Good Manufacturing Practice (GMP) requirements within an organization. Typically, departments with a third-party perspective, such as quality assurance departments, conduct these audits to inspect the conformity and effectiveness of procedures, records, and processes. Audit results are reported to management and lead to organizational improvements through corrective actions and preventive actions (CAPA). Internal audits are mandatory activities under various standards and regulations, including ISO standards and GMP regulations.

The primary purpose of internal audits is to objectively assess whether the quality policies and procedures established by the organization are being properly implemented and to continuously improve the effectiveness of the system.

Characteristics of Japan’s “Self-Inspection”

Japan’s unique “self-inspection (jiko tenken)” is an inspection activity conducted by pharmaceutical manufacturing facilities as stipulated in Article 18 of the GMP Ministerial Ordinance. The revised GMP Ministerial Ordinance, which came into effect in August 2021, clarified that the results of self-inspection must be reported in writing to the organization responsible for quality assurance operations and to the manufacturing manager. This revision has improved international harmonization.

In Japanese practice, the mainstream approach has been for personnel in each department to periodically verify their own department’s procedures and work environment using checklists and similar tools. A characteristic feature is the emphasis on self-evaluation by each department, with greater focus on confirming compliance status rather than identifying non-conformities.

However, in the past, there have been cases where serious problems and risks were overlooked due to formalistic practices such as “filling out checklists” and “conducting perfunctory inspections.” During the comprehensive self-inspection conducted from 2015 to 2016, discrepancies with marketing authorization documents were found in approximately 70% of all products, revealing challenges in the effectiveness of self-inspection.

International “Self Inspection” Requirements

The positioning of “Self Inspection” in international GMP standards varies slightly by regulation, but it is clearly required in many international regulations. The following table presents the requirements in major international regulations.

Comparison of Major International Regulations

Regulation/Guideline	Self Inspection Requirement	Key Features
EU GMP Chapter 9	○ Clearly Required	Conducted by independent personnel. All observations must be recorded, and corrective measures must be proposed. Verifies compliance with quality assurance principles
PIC/S GMP Guide Chapter 9	○ Clearly Required	Similar requirements to EU GMP. PIC/S member countries implement this as a basis for mutual recognition
WHO GMP	○ Clearly Required	Periodic implementation and documentation. Recommends implementation by independent qualified personnel
ASEAN GMP Chapter 10	○ Clearly Required	Aligned with PIC/S. Recommends implementation by teams from multiple departments
US FDA 21 CFR Part 211	△ No Clear Requirement	No explicit provision for Self Inspection, but FDA recognizes it as a valuable tool for quality system improvement

EU GMP Chapter 9 Requirements

EU GMP Chapter 9 specifies Self Inspection as follows:

• Must be conducted to monitor the implementation and compliance with GMP principles and to propose necessary corrective measures
• All Self Inspections must be recorded
• Reports must contain all observations made during the inspection and, where applicable, proposals for corrective measures
• Statements on actions subsequently taken must also be recorded

PIC/S and WHO GMP Requirements

The PIC/S GMP Guide and WHO GMP also establish similar requirements, emphasizing the following points:

• Implementation by qualified personnel with independence and objectivity
• Comprehensive evaluation covering the entire quality system
• Periodic implementation based on documented procedures
• Appropriate implementation and follow-up of corrective and preventive actions (CAPA)

US FDA Position

The US FDA’s cGMP (21 CFR Part 211) does not contain explicit requirements for Self Inspection. According to FDA policy (CPG Sec. 130.300), during routine FDA inspections, the agency will not review or copy reports and records resulting from internal audits conducted under a written quality assurance program. However, documentation of corrective actions must be retained.

Nevertheless, the FDA recognizes Self Inspection as a valuable tool for ensuring regulatory compliance and improving quality systems, and it is widely implemented in the industry as an important quality assurance activity.

Common Elements in International Regulations

The “Self Inspection” emphasized in international GMP standards shares the following common characteristics:

1. Independence and Objectivity: Evaluation from an independent perspective, such as by the quality assurance department
2. Comprehensiveness: Inspection that oversees the entire quality system
3. Detailed Examination: Thorough evaluation rather than superficial checks
4. Specific Recommendations: Proposals that lead to process improvement
5. Thorough Follow-up: Effective implementation and verification of corrective measures

These are positioned as important tools for organizations to voluntarily identify issues, address them sincerely, and promote continuous improvement.

Key Differences Between Japanese and International Regulations

The following table summarizes the main differences between Japan’s self-inspection and international Self Inspection:

Perspective	Japan’s Self-Inspection (Traditional)	International Self Inspection
Implementer	Department personnel inspect their own departments	Conducted by independent quality assurance department, etc.
Independence	Limited (evaluation by own department)	High (third-party perspective)
Depth of Evaluation	Focused on checklist verification	Detailed and thorough inspection
Purpose	Confirmation of compliance status	Issue identification and continuous improvement
Reporting	Within department/to quality assurance	To entire organization including management
Follow-up	May be limited	Thorough CAPA and follow-up

Note: With the 2021 GMP Ministerial Ordinance revision, international harmonization has improved in Japan, including clarification of reporting to the quality assurance department.

Importance of Meaningful Quality System Evaluation That Avoids Becoming Formalistic

The Japanese pharmaceutical industry has experienced multiple cases of manufacturing and quality management irregularities in the past. The background to these cases included the following issues:

• Management’s lack of understanding of the field
• Culture of information concealment
• Overlooking of serious problems due to formalistic self-inspection
• Corporate culture prioritizing profitability

In response to these problems, the 2021 GMP Ministerial Ordinance revision included changes to enhance the effectiveness of the quality system, such as strengthening management responsibility, thorough quality risk management, and clarification of corrective and preventive actions (CAPA).

To achieve truly meaningful quality system evaluation, the following points are important:

1. Ensuring Objectivity and Independence

It is important to identify problems from an objective perspective through evaluation from a third-party standpoint, such as the quality assurance department.

2. Management Commitment

Management must actively engage in fostering quality culture and utilize Self Inspection results in management decisions.

3. Effective Corrective Actions

True improvement based on root cause analysis is required, rather than formalistic responses.

4. Culture of Continuous Improvement

Rather than making “Self Inspection” itself the goal, it is important to foster a quality culture as part of corporate culture and pursue quality assurance with field personnel and management working together.

5. Implementation from a Global Perspective

It is necessary to understand international regulatory requirements and establish an audit system compliant with global standards.

Conclusion

While both “internal audits” and “Self Inspection” form the foundation supporting quality systems, there are important differences in their significance and practical implementation. Particularly as international regulations become more sophisticated and pharmaceutical products increasingly flow globally, the following points are crucial for Japan’s “self-inspection” to become truly meaningful quality system evaluation:

• An attitude that does not cling to one’s own customs or formalism
• Establishment of an effective audit system from a global perspective
• Implementation of evaluations with independence and objectivity
• Fostering of quality culture throughout the organization, including management

Building upon the improved international harmonization achieved through the 2021 GMP Ministerial Ordinance revision, adopting a posture of practicing true “Self Inspection” will lead to sustainable growth and earning international trust. Going beyond formalistic compliance and continuously improving quality assurance activities that prioritize patient safety first is the mission required of the pharmaceutical industry.

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References and Regulations

• Ministerial Ordinance on Standards for Manufacturing Control and Quality Control of Drugs and Quasi-Drugs (Ministry of Health, Labour and Welfare Ordinance No. 90 of 2021)
• EU GMP Guide Part I Chapter 9: Self Inspection
• PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009)
• WHO Technical Report Series, Good Manufacturing Practices
• ASEAN GMP Guidelines Chapter 10: Self Inspection
• FDA 21 CFR Parts 210 and 211
• FDA CPG Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections