Guide13.3

GMP principles in the blending room

Second-person check: an independent person verifies identity, weight and calculations to reduce human error.
Contemporaneous records: times, weights and readings are recorded as they happen, proving the process stayed within limits throughout, not just at the end.
Critical process parameters (CPPs): variables such as blend time, speed, fill level and room conditions that must stay within validated ranges.
Bulk product: blend that has completed processing but not final packaging. Store it sealed, labelled and under controlled conditions to prevent contamination, degradation or mix-up.
Equipment qualification and cleaning: equipment must be qualified and cleaned between batches and products to prevent cross-contamination and keep validated performance.
Risk assessment: charging, blending, milling, drying, temperature and human error are evaluated and controlled.

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