CASE STUDY Validation of Manufacturing Process

Validation of Manufacturing Process


Soft capsule manufacturing process.

Scope of work

The validation of the manufacturing process included, among other things, the following aspects:

  • determination of the process-critical parameters at the stage of each operation (input formation, hull formation, capsule filling, drying)
  • evaluation of the qualification status of all the equipment involved in the process
  • evaluation of the manufacturing documentation – necessary specifications, technology instructions, production report template, etc. as well as staff training,
  • analysis of product for consistence with the specification on different stages


A sampling plan (inspection stages, number of samples) was prepared on the basis of a risk analysis, taking into account the components listed above.

The validation was performed on 3 production batches. For each batch, statistical test results were prepared and the process capability ratios: Cp (a measure of scattering of a given feature in relation to the tolerance field) and Cpk (a measure of shift of the mean value of a given feature compared with its nominal value and tolerance limits) were determined.

The validation confirmed that the processes ran in a stable way and the finished product was consistent with the specification.


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