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Pharmaceutical Technology Regulatory Sourcebook October 2020 21 driver of the experimental activities. To generate specific data on the considered product it is fun- damental to identify suitable indexes (i.e., identify how to measure experimentally each effect). Table III suggests a series of studies to investigate and acquire experimental knowledge on a tablet in the different manufacturing steps. Finally, Table IV provides insights on the in- vestigations to be performed during process design phase. Process performance qualification (PPQ) The process qualification evaluates if the process design is reproducible based on the following. Product knowledge. Focused on understanding the specifications, stability performance, and CQAs of the product to be validated. Process understanding. The knowledge on how the material and equipment variations inf lu- ence the product performance. This knowledge comes from: • Understanding of the stage 1 (design step) • Data from full scale batches • Understanding of the process parameters ef- fect on the process result • Experience with a similar process. Control strategy. Includes an evaluation of the controls to meet CQAs, including raw material specifications, equipment performance, in-process controls, and controls on the finished product. Ac- cording to the ICH Q10 definition (6), the control strategy is "a planned set of controls, derived from current product and process understanding, that assures process performance and product quality. The controls can include parameters and attributes related to drug substance and drug product mate- rials and components, facility and equipment op- erating conditions, in-process controls, finished product specifications, and the associated meth- ods and frequency of monitoring and control." The control strategy is an important part of a quality- by-design approach: it should ensure the process performance and product quality using a set of controls planned according to process understand- ing and product knowledge. An adequate control strategy might include: Table III. Potentially critical process parameters and response for a tablet (Contin.). PAT option: blend uniformity end point monitored by using a process analyzer. Lubrication Response (test) Time Particle size distribution Speed Flowability, bulk density, tapped Loading density PAT option: distribution uniformity end point monitored by using a process analyzer. Tableting Response (test) Pre-Compression Force Tablet characteristics Compression Force (mean weight, weight variation, disintegration, friability, crushing strength, thickness) Dwell time Dissolution rate Feeder speed Appearance Assay Content uniformity Loss on drying PAT option: assay and content uniformity monitored by using a process analyzer. * The term response (test) refers to test/s that can be performed at that specific stage of the process.