Effective sampling during process validation ׀ Process qualification sampling plan

Sampling procedure during process validation:

For qualification of a process sampling stages & locations are critical parameters. Actually, effective sampling is ultimate part of process validation. During validation of a wet granulation drug product, following stages as well as locations must be consider to qualify the process. At granulation phase, sample should be collected as follow-

• Premixing
• Wet mixing
• Dry mixing 

Premixing: 

During this stage, sample should be collected from the RMG after completing of premixing phase. T-1, T-2, T-3 (Top 1,2 &3); B-1 & B-2 (Bottom 1.2). Sampling locations are as illustrate below-

Fig: Sampling location after premixing

Wet mixing: 

During this stage, sample should be collected from the RMG after adding of binding agent.  T-1, T-2, T-3 (Top 1,2 &3); B-1 & B-2 (Bottom 1.2).

Fig: Sampling location after addition of binding agent

Dry mixing: 

During this stage, sample should be collected from the FBD after completing of final drying. T-1, T-2, T-3 (Top 1,2 &3); B-1 & B-2 (Bottom 1.2). Sampling locations are as illustrate below- 

Fig: Sampling location after drying

Note: Only performed the % LOD test