CPP

CPP stands for Critical Process Parameter. In pharmaceutical production, CPPs are process parameters that have a significant impact on a Critical Quality Attribute (CQA) of a drug product. Monitoring or controlling these critical process parameters is essential to ensure the manufacturing process consistently produces a drug product with the desired quality attributes.

Examples of CPPs may include temperature, pressure, pH, mixing time, drying time, and sterilization conditions, among others, depending on the specific manufacturing process and the critical quality attributes of the drug product.

By focusing on Critical Process Parameters, pharmaceutical manufacturers can ensure the reliability, consistency, and quality of their drug products. The careful control and monitoring of these parameters contribute to the delivery of safe, effective, and high-quality medications to patients, promoting confidence in the pharmaceutical industry and safeguarding public health.