Anyone who manufactures or distributes drugs must comply with the internationally accepted rules of GMP (Good Manufacturing Practice). The packaging of pills, tablets and capsules in various dimensions must therefore be carried out in accordance with the GMP regulations. Besides, complementary country-specific regulations should be noted, for example, the “Mengenangabeverordnung MeAV “ (Switzerland) or the “Verordnung über Fertigpackungen (Fertigpackungsverordnung) FertigPackV “ (Germany).
Under these directives it is mandatory that the quantities must be continuously tested and that the test results must be documented. The tests must be carried out “in accordance with generally recognized principles of statistical quality assurance” with a suitable control instrument, in the present case with a precision test counter. In practical terms, it is to prove that the nominal quantity in the average of all samples is maintained and that the allowable negative error of a single package is not undershot.
The tablet and capsule test counter elmor C3Pharma offers this possibility. The amount is determined using a precision counter wherein all parts in contact to the products are made of FDA compliant materials. The control software guides the user through all steps of the exams including the respective required qualifications (IQ, OQ). The test results are stored, statistically analysed and displayed in a suitable form. The system is highly protected against data manipulation. The control software is designed according to the requirements of 21 CFR Part 11.