Regulatory starting materials (RSMs) are the essential chemical substances that underlie the GMP-compliant synthesis of active pharmaceutical ingredients (APIs).
These components are vital when it comes to defining the structure and quality of the final API (Figure 1).
Selected based on regulatory definitions and scientific rationale, RSMs must be reliably sourced to support the complex, multistep processes that follow.
Their role extends beyond technical aspects; RSMs also act as a critical quality control checkpoint that influences the efficiency, safety and traceability of pharmaceutical manufacturing operations.
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