The purpose of process validation is to determine whether all relevant quality attributes and process parameters, including:
The documentation of the assessment process for parameters, attributes, and their criticality should be clear and incorporate the results of risk analysis.
The validation process for new products should include all available doses for sale and all production sites where the product is manufactured for sale. This process should be carried out by personnel routinely involved in production.
Validation batches should be manufactured in quantities consistent with the registration dossier and using equipment intended for routine production batches.
Process validation should be based on statistical analysis of results (using process capability indices).
The validation process for the manufacture of coated tablets was carried out on a dedicated process line comprising the following equipment: weighing scales, tanks for preparing granulating fluid, a mixer-granulator, fluid bed dryer, granulation mill, rotary drum mixer, tablet press, mixer for preparing coating solution/film, and coating machine.
All of the above equipment had been previously qualified by our team (eCValidation).
Critical quality attributes for coated tablets were also identified, along with their testing frequency, including: mass loss after drying in the granulate, tablet mass, tablet hardness, tablet diameter, tablet thickness, disintegration time, tablet mass during and after the coating process.
Despite the short project timeline, significant workload, and complexity of the process, the validation was completed within the declared project timeframe (with a positive outcome).
A summary report was prepared after the validation process concluded.
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