In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA ...
The VLSI design cycle is divided into two phases: Front-end and Back-end. Front-end covers the architectural specifications, coding and verification, whereas back-end involves the physical ...
In-house harmonization of excipient specifications ensures compliance with multiple pharmacopoeias, reducing redundant testing and aligning with global regulatory expectations. Specification ...
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