CASE STUDY Validation of Manufacturing Process

Validation of Manufacturing Process

Subject

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

Result

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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