MANUFACTURE VALIDATION OF TABLETS “URONEFRON”
DOI:
https://doi.org/10.11603/2312-0967.2017.4.8343Keywords:
validation test, acceptance criteria, technological process, «Uronefron» tablets.Abstract
The aim of the work. Providing the documentary evidence, which will confirm that «Uronefron» manufacturing process in the form of film-coated tablets yields the manufacture of the product with the established quality.
Materials and Methods. Validation studies were performed on 3 product batches.
Process validation for «Uronefron» tablets was conducted on all stages of production process defining the critical parameters i.e. raw material preparation, production of tablet blend, hold of tablet blend, tableting, film-coating of tablet cores.
Results and Discussion. For the defined critical process parameters of the product manufacture, the validation tests, which permit to define the allowable excursion limits for these parameters, were performed.
The results for validation tests at each stage of «Uronefron» production process meet the eligibility criteria.
Conclusions. Process validation for «Uronefron» tablets has confirmed the qualification of the production personnel and adherence to the prescribed parameters; has demonstrated that the production equipment of the site is capable of reproducing the parameters of manufacturing process that will yield the expected quality level of the intermediate product and finished products; has demonstrated the reproducibility and standardness of the quality attributes for intermediate product and finished product, according to regulatory documentation.References
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