ISPE GAMP 5 Guide for Pharmaceutical Industry
- ICH guidance Q8, Q9 & Q10.
- Product Quality Lifecycle Implementation (PQLI).
- USFDA cGMP
- PIC/S guidance on Good Practices for Computerized System in Regulated GxP Environment.
- Emerging industry standards such as those produced by ASTM E55 committee.
Purpose
GAMP (Good Automated Manufacturing Practice) guidance aims to achieve computerized systems that are fit for intended use and meet current regulatory requirements.
GAMP guidance is applicable for –
- facilitates the interpretation of regulatory requirements
- establishes a common language and terminology
- promotes a system life cycle approach based on good practice
- clarifies roles and responsibilities
GAMP guidance has been designed for use by a wide range of disciplines and responsibilities, including:
- management,
- quality unit,
- research and development,
- manufacturing,
- laboratory,
- engineering,
- IT,
- Support staff,
- all associated suppliers.
Scope
This guide applies to computerized systems used in the regulated activities covered by:
- Good Manufacturing Practice (GMP)
- Good Clinical Practice (GCP)
- Good Laboratory Practice (GLP)
- Good Distribution Practice (GDP)
- Medical Device Regulations
These are collectively known as GxP regulations.
Key Concepts
There are five key concept of this guide –
1. Product and process understanding
2. Life cycle approach within a QMS
3. Scalable life cycle activities
4. Science based quality risk management
5. Leveraging supplier involvement
GAMP 5 Categories
Category 1: Infrastructure software (example: operating system, database engines, programming etc.)
Category 2: No longer available in GAMP 5
Category 3: Non-Configured products (example: firmware based applications)
Category 4: configured products (example: LIMS, ERP, Spread sheets etc.)
Category 5: Custom applications (example: varies but include internally or externally developed IT applications)
Key Terms
- Computerized System
- Computerized System Validation
- GxP Compliance
- GxP Regulated Computerized System
- GxP Regulation
- Process Owner
- Quality Management System (QMS)
- Subject Matter Expert (SME)
- System Owner
The GAMP 5 2nd Edition, was released in July 2022, replacing the First Edition unveiled in 2008. It should be seen as part of a broader industry trend taking place: the evolution from computerized system validation (CSV) to computerized system assurance (CSA).
In keeping with the broad emphasis shift to agile, risk based adoption of modern digital tools for GxP-regulated businesses, the Second Edition has brought 10 key changes to how 'good automated manufacturing practice' is defined.
1. Non-linear recognition
The First Edition of GAMP 5 assumed a broadly linear approach to software development, which no longer reflects how modern software is brought to life.
The Second Edition recognizes the largely non linear, agile and more cyclical nature of modern software development.
2. Document change
Legacy GAMP validation documents which assume a linear software approach, like installation, operation and performance qualification documents, are no longer relevant for the Second Edition.
There's therefore a shift in emphasis from traditional documents like IQs, OQs and PQs to risk-based records of information, held in appropriate systems, that take into account the modern software lifecycle.
3. Critical thinking
Critical thinking is a huge cornerstone of computerized system assurance, both in the GAMP 5 Second Edition and the FDA's new guidelines unveiled in September 2022.
4. Update of development appendices
The areas of GAMP 5 focusing on user requirements specifications (URS) and functional/design specifications have been tweaked to reflect the new world of modern, #agilesoftware.
5. Appendix on electronic production of records updated
The rise of cloud based technology and block chain has been taken into account. The appendix also clarifies new expectations around electronic records, signatures and audit trails.
6. ITIL (IT Infrastructure Library)
7. New appendix about blockchain and distributed ledger technology
8. New appendix about AI and machine learning
9. New appendix about use of agile within a GxP environment
Agility is a core ingredient of the Second Edition. A new section has been added to clarify these new expectations.
10. New appendix about modern infrastructure and infrastructure management
The replacement of paper with automation and AI is a seminal, defining change for how life science companies manage quality and compliance. The Second Edition contains a fresh appendix outlining the modern GxP infrastructure, and how new digital tools should be implemented and applied.
Read also: GAMP 5 Guidelines for Computer System Validation
Note: GAMP documents are guides not standard. It is the responsibility of regulated companies to establish policies and procedures to meet applicable regulatory requirements.
