ASTM E2500

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.

Approach

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

ASTM2500_Overview

The supporting processes

The supporting processes support the validation during the whole process.

risk management
design review
change management

Differences

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