Frequently asked questions
1. At which stage should a company submit a request for inspection of its production site located outside Russia? What is the regular course of action accepted by the Ministry of Industry and Trade in issuing (or not) its conclusion?
The company should independently decide when an application should be submitted for inspection of its production site.
The following should be taken into consideration:
- The Ministry has 30 working days to review the request (provided the file was submitted correctly).
- The requested inspection should be conducted within 160 working days from the day the decision authorizing the inspection was issued.
- The company should have a well-developed and fully operational pharmaceutical quality control system that meets the GMP requirements.
- The company should employ only qualified staff operating proper equipment and technical tools in acceptable office and laboratory areas.
2. What should the applicant submit as a regulatory document if the drug is in preparation for registration or is already in the process of registration?
- In case the drug is already in the process of registration, the applicant should present exactly the same documents that were filed along with the registration dossier.
- If the company is only preparing for registration, it is considered premature to submit an application for an inspection.
- In order to prevent cross contamination, Annex 13, Statistical Process Control (SPC) should not be lower than the requirements of the Pharmacopoeia.
3. Can the inspector request to review a draft of the Regulatory Document?
Yes, he/she can.
3.1. Is it justified during an inspection of a QC lab to compare QC methods in the draft Regulatory Document with the fact and/or Module 3?
The question is not correctly articulated. Yet, it is acceptable.
4. How long is the wait between submitting a request and the actual inspection?
This question is regulated by Decree №1314 issued by the Russian Government on Dec. 3, 2015 regarding “Conformity of drug manufacturers to GMP requirement” (Please also refer to the “Rules of organizing and conducting an inspection…”)
- An inspection should take place no later than within 160 working days from the date when the Russian Ministry of Industry and Trade issues an authorization for inspection. The inspection cannot last longer than 10 working days (exclusive of time spent for travel to the inspection site).
- Upon receipt of the application package and required paperwork an authorized organization will have 20 working days to register the foreign manufacturer into the planned inspections schedule (hereinafter – Schedule) that should be agreed on with the regulating body.
- Information and changes reflected in the Schedule are officially published on the web sites of the authorized organization and the regulatory body within 3 working days from making a respective entry or a correction.
5. What drugs should be included in the Register(registered, in the process of registration: Registration Dossier is ready, but not submitted to MoH / Registration Dossier is not ready, not submitted to MoH / preclinical & clinical studies, etc.)?
With regard to drugs that have been registered – the answer is positive.
Those in the process of registration:
- RD is completed but not submitted to the Ministry of Health – positive.
- RD is neither available nor submitted to MoH – the answer is no.
- Under preclinical & clinical studies – yes.
6. Is it possible to include in the Register, drugs that are at the project stage, if the transfer is not finalized?
Negative, this is impossible.
7. Is it possible to initiate changes in the Product Register during the inspection (i.e. when the audit is being carried out)?
Negative, unfortunately this is not possible after the Agreement was signed, calculations verified, and particular auditors and inspectors were identified based on the area of their expertise.
8. If there is no validation of the process for one of the drugs in the Register, but no critical remarks were received for it, is it possible to exclude this drug from the Register and request a GMP Certificate?
Such decisions are under Russian MIT’s jurisdiction, and are made based on information contained in the final report and correspondence received from the manufacturer.
9. What is the proper procedure to add drugs on to the Register after the GMP Certificate was issued?
If the name and/or address of the manufacturer (including foreign ones), or the list of drugs specified in the valid GMP Certificate produced at the same production site and in the same conditions, the regulatory body can authorize a new GMP Certificate be issued without conducting an inspection; the expiration date of the new GMP Certificate will remain unchanged as it appeared on the previously issued one.
10. When does it become possible to apply for another inspection if the initial application for a GMP Certificate is declined? What is the procedure? Should we file in a completely new application package? Is it possible to amend all deviations (and present a CAPA report) and re-schedule a new inspection dates? What is assessed during the repeated inspection: only previous deviations are addressed or the whole procedure begins from scratch?
A new application package should be submitted. The manufacturer is expected to present a CAPA report. A new inspection is conducted on the grounds of a relevant order issued by the Russian MIT and based on the application paperwork, paying special attention to GMP deviations revealed during the previous auditing.
11. How will the manufacturer be notified of the inspection dates? Will the company receive a notice that documents were forwarded to the Inspectorate if the initial application was submitted to the Ministry of Industry and Trade? How soon the inspection is scheduled?
- Information and changes reflected in the Planned Inspections Schedule are officially published on the web sites of the authorized organization and the regulatory body within 3 working days from making a respective entry or a correction.
- Within 3 working days after the Schedule has been agreed on, the authorized organization shall notify the foreign manufacturer or its authorized representative about the dates of the inspection. An agreement should be signed defining inspection procedures, related expenses, the rights and obligations of the inspectors and the foreign manufacturer (hereinafter referred to as the Agreement). Within 20 working days from the date of the Agreement, the costs associated with the inspection shall be paid to the authorized agency in the amount specified in the Agreement, but not exceeding the maximum amount of inspection fees, approved by the regulatory body, calculated on the basis of the methodology approved by the regulatory body.