ASTM E2500-20: Guide for Pharmaceutical Manufacturing Systems & Equipment

The ASTM E2500-20 is a standard guide for the specification, design, and verification of pharmaceutical and biopharmaceutical manufacturing systems and equipment. It aims to establish a risk-based approach to ensure the quality, safety, and efficacy of manufactured products.

The key aspects of the standard guide include:

Lifecycle Approach: Emphasizes holistic perspective for pharmaceutical manufacturing. Covers concept to decommissioning, applying quality and risk management principles throughout the entire lifecycle.

Risk-Based Approach: Guide promotes risk-based specification, design, and verification of manufacturing systems. Prioritize resources to address critical aspects impacting product quality, safety, and efficacy.

Specification Development: ASTM E2500-20 offers guidance on clear, comprehensive manufacturing system and equipment specifications. Align with product requirements, process understanding, and risk assessments, ensuring fitness for intended use.

Design & Verification: Guide provides framework for system and equipment design. Ensure alignment with specifications, conduct thorough verification (e.g., Factory Acceptance & Site Acceptance Testing), and compliance with regulations.

Science- & Risk-based Commissioning and Qualification: Guide advocates integrated activities. Focus on critical aspects impacting product quality, safety, or efficacy, streamlining the verification process.

Documentation & Traceability: ASTM E2500-20 stresses comprehensive documentation throughout specification, design, and verification. Captures critical information, maintains traceability for transparent and auditable manufacturing system lifecycle.

By following the guidance provided in ASTM E2500-20, companies in the pharmaceutical and biopharmaceutical industry can establish robust, risk-based processes for the specification, design, and verification of their manufacturing systems and equipment, ensuring product quality, safety, and regulatory compliance.

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