Material Qualification in pharmaceutical manufacturing is the comprehensive process of evaluating, assessing, and approving raw materials, packaging materials, and intermediates to confirm their suitability, quality, and compliance with predefined requirements, specifications, and standards. This process encompasses thorough testing, inspection, documentation, and supplier evaluation to authenticate material properties, characteristics, and performance against established acceptance criteria. Materials that meet these criteria are sanctioned for use in manufacturing processes, whereas non-conforming materials are either rejected or subjected to corrective measures. This ensures that all materials used are of the highest quality and safety standards, thereby maintaining the integrity and efficacy of the final pharmaceutical products.
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