English to Russian Medical Medical: Pharmaceuticals

Material Specification MS804285-04 of 16 Dec 2015 was valid for Germany and GB.

Keywords:

Since a European Drug Master File was available for Prazepam, which was also provided to the Regulatory Authorities, the respective information on test 1 to 1 was included in our own regulatory filings.

The regulatory data had not been adapted to the changed state-of-the-art, in particular changes in the compendial monographs, since 2002 although, e.g. the performance of the test for residual solvents, differs in various points from the procedure validated in 1995.

Evidently, the change control procedure was not effective here.

Note:
The methods used for testing starting materials, active ingredients, and medicinal products must be applied according to the current state of scientific and technical knowledge, among other things Ph.Eur. has to be taken into account.