We have analyzed the domestic and international regulation, documents and proposed
a methodology for determining critical control points in the production of high-tech
synthetic pharmaceutical substances.
We presented the results of the analysis of regulatory documents to justify the
introduction of the new term checkpoint, formulated the definition. For unification,
we proposed to use the term control points, which combine the terms control point and
critical control point. A selection of control points for a typed production scheme for a
pharmaceutical substance of a synthetic nature is described.
To produce a high-tech substance of a synthetic nature, it is recommended to apply
the principle of typification in describing the process and its subsequent analysis in
order to improve production. Management of the production process is carried out
at critical control points, for the identification of which it is necessary to propose an
algorithm based on risk assessment. Evaluation should be based on the influence of the
process parameter on the quality score.