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 www.astm.org.
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.
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
- 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|