In the pharmaceutical industry, quality assurance of computer systems is a critical element directly linked to patient safety. GAMP (Good Automated Manufacturing Practice), known as the global standard for computerized system validation, was actually born not as guidance for pharmaceutical companies, but as guidance for suppliers. This article explains the birth story of GAMP and its characteristics, incorporating specific episodes.
1991: Birth in the United Kingdom – Triggered by FDA Inspections
The history of GAMP dates back to 1991 in the United Kingdom. The catalyst was FDA (U.S. Food and Drug Administration) inspections received by two major British pharmaceutical companies: Glaxo (now GSK) and ICI (later Zeneca, now part of AstraZeneca).
During these inspections, both companies received severe findings indicating that “pharmaceutical-level quality control was lacking” in their computer systems. At that time, the pharmaceutical industry was experiencing rapid advancement in the computerization of manufacturing facilities and quality control systems. However, many suppliers providing these systems did not have sufficient understanding of the stringent regulatory requirements specific to the pharmaceutical industry.
In other words, pharmaceutical companies were demanding high-quality systems, but suppliers were developing and delivering products based on general industrial system standards. This gap surfaced as inspection findings during FDA inspections.
Note: Glaxo was originally a trademark for infant milk powder, which later became the foundation of the pharmaceutical company.
Supplier Education: A Revolutionary Concept
Faced with this problem, the British pharmaceutical industry chose a revolutionary approach different from conventional methods: the concept of “educating suppliers.”
In the traditional approach, each pharmaceutical company would individually explain requirements to suppliers and request compliance with regulatory requirements. However, this was inefficient, and suppliers became confused by the different demands from each company.
Therefore, the British pharmaceutical industry adopted a policy of creating common industry-wide guidance to help suppliers understand pharmaceutical-level quality control. GAMP was born from this concept.
The 1994 London Conference: The Beginning of International Expansion
A crucial turning point for GAMP came with the first international conference held in London in 1994. At this conference, a draft of the supplier-oriented guidance was presented.
The conference was attended not only by participants from the UK but also by pharmaceutical companies and suppliers from various European countries and the United States. Attendees recognized that this guidance was not merely a solution to British problems, but a solution to common challenges faced by the pharmaceutical industry worldwide.
Why Was It Oriented Toward Suppliers? Three Key Reasons
The reasons why GAMP was created for suppliers can be specifically summarized into the following three points:
First, from an efficiency perspective: For example, if 10 pharmaceutical companies each conduct business with 5 suppliers, individual education would require 50 separate training sessions. However, with common guidance, the 5 suppliers only need to learn once.
Second, quality standardization: If suppliers understand regulatory requirements from the outset, development proceeds with a fundamental understanding of “why this document is necessary” and “why this test must be conducted,” resulting in substantive quality assurance rather than mere formality.
Third, improved inspection readiness: FDA inspections require the presentation of system design rationale and verification records. If suppliers understand regulatory requirements, these documents are also properly created, eliminating the need for pharmaceutical companies to recreate them later.
Evolution of GAMP’s Fundamental Philosophy
GAMP’s fundamental philosophy has evolved over time.
Early GAMP (1991-2007)
Initially, GAMP primarily focused on the lifecycle approach. By clearly defining the necessary activities at each stage from system conception to decommissioning, it showed suppliers “when and what to do.”
GAMP 5 and Beyond (2008-Present)
GAMP 5, published in 2008, explicitly introduced the risk-based approach. Rather than requiring the same level of validation for all systems, this concept calls for appropriate levels of quality assurance activities according to the degree of impact on patients.
For example, software for medical devices used directly in patient treatment and inventory management systems require different levels of validation. By clarifying these differences, efficient and effective quality assurance became possible.
Development as an International Standard: The Role of the GAMP Forum
The GAMP Forum, established following the 1994 London conference, played a crucial role in the international dissemination of GAMP. Through the following activities, the GAMP Forum elevated GAMP to global standard status:
Regular revision of guidance: Responding to technological advances and regulatory changes, with GAMP 5 Second Edition published in 2022.
Educational activities: Seminars and workshops held worldwide, training programs for suppliers.
Dialogue with regulatory authorities: Consultations with FDA, EMA (European Medicines Agency), Japan’s Ministry of Health, Labour and Welfare (MHLW), and others, reflecting GAMP principles in regulatory guidance.
Concrete Transformations Brought About by GAMP
The emergence of GAMP brought about the following concrete transformations in the pharmaceutical industry:
Changes in Suppliers
- Establishment of development departments specialized in the pharmaceutical industry
- Assignment of quality assurance personnel
- Development of standard products compliant with regulatory requirements
Relationship Between Pharmaceutical Companies and Suppliers
- Shift from “client and vendor” to “partners”
- Joint implementation of risk assessments
- Building long-term collaborative relationships
Industry-Wide Efficiency
- Templating of validation documentation
- Sharing of best practices
- Shortened inspection preparation periods
Current GAMP and Its Significance: Adapting to the Digital Age
As of 2025, GAMP continues to address new technological challenges. GAMP 5 Second Edition (2022) added guidance on cutting-edge technologies such as:
Cloud Computing: Considerations for data location, security, and availability
Artificial Intelligence and Machine Learning: Methods for algorithm validation, addressing continuous learning
Blockchain: Data integrity, new forms of audit trails
Agile Development: Transition from traditional waterfall methodology
Software as a Service (SaaS): Supplier assessment, data governance in shared infrastructure
Data Integrity: Enhanced focus on ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available)
Even with these new technologies, GAMP’s fundamental spirit of “collaboration with suppliers” remains unchanged. Rather, as technology becomes more complex, the importance of this collaboration increases.
Recent Regulatory Developments and GAMP’s Relevance
The pharmaceutical regulatory landscape continues to evolve, and GAMP remains highly relevant to current regulatory expectations:
FDA Guidance Alignment
FDA’s guidance on Computer Software Assurance (CSA) for Production and Quality System Software (2022) aligns closely with GAMP’s risk-based approach, emphasizing critical thinking over prescriptive documentation. This represents a significant shift from traditional computer system validation, and GAMP 5 Second Edition provides practical implementation strategies for CSA principles.
EU GMP Annex 11
The European Union’s GMP Annex 11 (Computerised Systems) continues to serve as a key regulatory reference, and GAMP provides detailed interpretation and implementation guidance for its requirements. The principles of supplier involvement and lifecycle management in GAMP directly support compliance with Annex 11.
Global Harmonization
GAMP has contributed significantly to global harmonization of computerized system validation approaches. Through its adoption by PIC/S (Pharmaceutical Inspection Co-operation Scheme) member countries, GAMP principles have become recognized worldwide, reducing the burden of multiple, conflicting validation approaches for global pharmaceutical companies.
Conclusion: Lessons and Future Implications
The birth story of GAMP teaches us the importance of viewing regulatory compliance not merely as a burden, but as an opportunity for quality improvement, and tackling it as an entire industry.
The findings that Glaxo and ICI received from the FDA inspection must have been severe for those involved at the time. However, rather than ending this experience as an individual company problem, they treated it as an industry-wide challenge and created an innovative solution through supplier education, which has led to GAMP’s success today.
The digitalization of the pharmaceutical industry will accelerate further in the future. New technologies such as IoT, big data, quantum computing, and advanced artificial intelligence systems are emerging one after another. To utilize these technologies safely and effectively for patient benefit, the spirit of “collaboration with suppliers” born in the UK more than 30 years ago will continue to serve as an important guideline.
The story of GAMP symbolizes the excellent culture of the pharmaceutical industry: turning crisis into opportunity and cooperating even with competitors to aim for the development of the entire industry. This spirit should serve as the foundation supporting the pharmaceutical industry’s quality assurance for the next 30 years.
Key Takeaways
The GAMP story offers several enduring lessons for the pharmaceutical industry:
Collaborative problem-solving: Industry-wide challenges are best addressed through cooperation rather than competitive isolation.
Proactive education: Investing in supplier education creates long-term value and reduces systemic risk.
Adaptive frameworks: Successful guidance must evolve with technology while maintaining core principles.
Risk-based thinking: Not all systems require the same level of control; intelligent prioritization improves both quality and efficiency.
Regulatory partnership: Constructive dialogue between industry and regulators leads to practical, effective standards.
As the pharmaceutical industry continues to embrace digital transformation, cloud technologies, artificial intelligence, and increasingly complex supply chains, the foundational principles established by GAMP remain as relevant as ever. The challenge for the next generation of quality assurance professionals will be to apply these time-tested principles to emerging technologies while maintaining the collaborative spirit that made GAMP successful in the first place.
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