Analytical Methodology: Validation, Verification, or Qualification – Choosing the Right Approach
Validation, verification, and qualification are often used interchangeably in pharmaceutical testing, but each has their own distinct meanings and all serve different purposes. Getting the test right is just as important in pharmaceutical manufacturing as making the drug. If the analytical method you go with is flawed, every result that follows is questionable. Beyond those […]
Phase-Appropriate Validation: How Tailored Approaches Support Cost-Effective Drug Development
Drug development is a complex and highly regulated process that necessitates ongoing validation to ensure drug product safety and efficacy. A phase appropriate method validation technique is applied at each step of drug development; with flexibility being provided in the initial stages where the methods can change. As the phases advance toward clinical use, strict […]