Answer :
ASTM standard E2500 focuses on a risk-based approach to pharmaceutical manufacturing system design and qualification, with key concepts including lifecycle management and critical quality assessment. Supporting ASTM standards like ASTM D698, D2435, and D2216 provide methods for material testing relevant to engineering quality and safety.
The ASTM standard E2500 relates to the specification, design, and verification of pharmaceutical manufacturing systems and equipment. A key concept of ASTM E2500 is the risk-based approach to the design and qualification of manufacturing systems. This approach focuses on critical aspects of manufacturing that impact product quality, patient safety, and regulatory compliance. Supporting processes involve validating those systems and components that are identified as critical. Performance qualification ensures systems consistently produce a product meeting its predetermined specifications and quality attributes.
ASTM standards used for testing certain characteristics also support ASTM E2500. For instance, ASTM D698 provides methods for assessing soil compaction which is pertinent to the quality of civil engineering projects. ASTM D2435 relates to the one-dimensional consolidation properties of soils providing valuable data for the analysis of soil structure interaction and stability in engineering. Similarly, ASTM D2216 specifies the procedures for determining the moisture content of soil and rock, which is vital for understanding various engineering properties.
ASTM E2500 encourages use of a structured lifecycle approach where development, validation, and manufacturing activities are interrelated. Furthermore, it promotes efficiency by allowing flexible and innovative approaches to system design, which is helpful for the continuous improvement and integration of new technologies into manufacturing processes.