A Critical Process Parameter (CPP) in pharmaceutical manufacturing is a measurable variable, factor, or attribute of a process that significantly influences the quality, safety, or efficacy of the product, necessitating stringent management within predefined limits to guarantee consistent manufacturing and uphold product integrity. CPPs are pinpointed through comprehensive risk assessments, detailed process characterisations, and a deep scientific understanding of the process’s capabilities and criticality. The meticulous control of CPPs within specific ranges or tolerances is crucial for maintaining robust process control, minimising variability, and ensuring adherence to quality requirements and regulatory standards, thereby safeguarding the consistent production of pharmaceutical products that meet all specified criteria.
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