Critical process parameters (CPP; German: kritische Prozessparameter) are process variables that impact the critical quality attributes (CQA) and thus the safety, efficacy and quality of a drug. These parameters must be strictly monitored and kept within certain specifications or ranges to ensure the required quality for the process.

Examples of critical process parameters:

• Temperature: In processes such as drying, granulation and sterilization, the temperature can have a significant effect on the quality of the end product.
• Humidity: When manufacturing tablets or storing materials, humidity (German translation: Feuchtigkeit) can negatively affect the stability of the product.
• Mixing speed: In mixing and granulation processes, the mixing speed can influence the homogeneity (German translation: Homogenität) of the mixture and granule size.
• Pressure: In processes such as tableting and freeze-drying (translation into German: Gefriertrocknen), pressure can influence the density and solubility of the product.
• Time: The amount of time a product undergoes a certain process can also have a decisive effect on its quality, e.g. the sterilization time.

Monitoring the critical process parameters is of critical importance to maintaining the quality of drugs. Deviations from the established specifications of the CPPs may result in the manufacture of products that do not meet the established quality standards, which may affect the safety and efficacy of the drug. It is therefore important to carefully determine and validate CPPs during the development and optimization of manufacturing processes in order to ensure reproducibility and quality assurance at all manufacturing stages.

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