he company itself must decide when an application for inspection of a production site should be formed.
At the same time, it is necessary to consider:
- The time-line consideration of an application by the Ministry is 30 working days (if the file was compiled correctly and qualitatively).
- 160 working days are allocated for an inspection, counting from the date of a decision made by the authorized body to conduct the inspection.
- The enterprise should develop and successfully implement a pharmaceutical quality system that includes compliance with the requirements of the Rules of Good Manufacturing Practice.
- In the company must work qualified personnel, it must have the proper facilities, equipment and technical means.