ASTM E2500

ASTM E2500-7 is a consensus guide with legal reference and global impact. The has Copyright by ASTM Int'l (all rights reserved) and can be purchased at

The ASTM E2500 has a lean approach for validation and is in line with FDA’s Pharmaceutical cGMP's for the 21st century, EMEA, GAMP 5 and ICH Q8 and Q9.


The guide allows flexibility in changes before final acceptance of the system. The level of detail for documentation is based on risk in relation to patient safety and product quality. Before acceptance of the system the design and implementation is done under Good Engineering Practice (GEP) by Subject Matter Experts (SME); after acceptance GMP related changes are managed and approved by QA.

Key concepts

The following key concepts are mentioned in the guide:

  • Risk-based Approach
  • Science-based Approach
  • Critical Aspects of Manufacturing Systems
  • Quality by Design
  • Good Engineering Practice
  • Subject Matter Expert
  • Use of Vendor Documentation
  • Continuous Process Improvement


The validation process

The validation process is divided into the following sections

  • Requirements definition
  • Specification and design
  • Verification
  • Acceptance and release


The supporting processes

The supporting processes support the validation during the whole process.

  • risk management
  • design review
  • change management



The differences betwee the ASTM guide and the ISPE Baseline guide are shown in the table below.

ISPE Baseline guide ASTM guide
  • Design inputs
  • Impact assessment
  • Design Qualification
  • Commissioning
  • Multiple trial runs to get things right
  • IQ, OQ, PQ and acceptance criteria
  • GEP Scope and QA Scope overlapped
  • Focused on Documentation Deliverables
  • Rigid Change Management

  • Design inputs
  • Design Review
  • Risk Mitigation
  • Critical Control Parameters define Acceptance Criteria
  • Verification Testing
  • Performance Testing
  • GEP Scope and QA Scope have clear boundary
  • Process, Product Quality and Patient Safety
  • Quality by Design, Design Space and Continuous Improvement