Drying, Miling and Blending Validation

Brief about Drying, Miling and Blending Validation:

Drying, Milling and Blending validation shall be considered as part of Prospective Process Validation. This validation performed to evaluate the drying time, temperature, particle size distribution and homogeneity of the material within the batch.

Purpose: The purpose of this validation is defined as the process of combining several centrifuge loads from a single crystallization batch to drying, milling and blending to get the homogeneous final API batch of drug substance. The validation performed for Drying, Milling and Blending as defined operations in BMR for drug substance. Preferably, three prospective process validation batches (Exhibit batches) should be selected for validation.

Critical process parameters for Drying, Milling and Blending operation for API need to specify in protocol with process operation no., process operation description and standard requirements as define in BMR.

Defined the sampling plan for drying, milling and blending operation of API including with following details
 
Ø  Stage No and Name
Ø  BMR operation no.
Ø  Test parameters (sample to be tested)
Ø  Acceptance criteria for test parameters
Ø  Reference specification no. to be followed for validation
Ø  Sampling point / location (sample to be drawn from which location e.g reactor, centrifuge, dryer etc).
Ø  Sampling Interval (to be required in reaction monitoring, blending validation samples etc)
Ø  Sampling container (Sample to be collect in which container)
Ø  Approx qty. of sample (required qty. of sample for analysis).

Validation sample shall be labelled with necessary details such as Name of Product, B. No., Stage, Sampled Date, and sampled by, Sampling point / location etc