When should an application for inspection of a production site located outside the Russian Federation be formed? What is the decision-making algorithm for issuing/non-issuing a conclusion by the Ministry of Industry and Trade of the Russian Federation?
The 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.
If a medicine is at the preparatory stage for registration or during the registration process, what should the applicant submit as a regulatory document?
- If a medicine is in the process of registration, the applicant must submit those documents that have been filed within the registration dossier.
- If a medicine is in the process of preparing for registration, then it is premature to file an application for inspection.
Does the inspector have the right to request a draft ND?
Yes, he does.
Is it reasonable to compare quality control methods in a ND project with fact and/or Module 3 when verifying a quality control laboratory?
Incorrectly formulated question. Yes, it is.
How long does the whole process take from the time of filing an application to the inspection itself?
Decree of the Government of the Russian Federation of December 3, 2015 № 1314 «On determining the compliance of medicines manufacturers with the requirements of the rules of Good Manufacturing Practice» (together with the «Rules for organizing and conducting inspection …»).
- Inspection should be carried out within a period not exceeding 160 working days from the date of the decision by the Ministry of Industry and Trade of Russia to conduct an inspection. The duration of an inspection may not exceed 10 working days, excluding travel time to an inspection site.
- The authorized institution shall, within 20 working days from the date of receipt of an application and documents from the authorized body, enter the foreign manufacturer in the inspection schedule (hereinafter referred to as the schedule), which isconfirmed by the authorized body.
- Information about the schedule and the changes made to it is being posted on the official web-sites of the authorized body and authorized institution on the Internet within 3 working days from the date of its preparation or changes to it.
What medicines need to be included in the List (Registered, in the process of registration: RD is ready, but not submitted to the MOH / RD is not ready, not submitted to the MOH / undergoing preclinical/clinical studies, etc.)?
Registered – yes.
In the process of registration:
- RD is ready, but not submitted to the MOH – yes.
- RD is not ready, not submitted to the MOH – no.
- Undergoing preclinical/clinical studies etc. – yes.
Is it possible to include in the List medicines that are at the project stage, if the transfer is not yet implemented?
Is it possible during the inspection process (when an audit is actually taking place) to amend the list of products?
If there is no process validation for one of the medicines presented in the list, but there are no critical observations, may this medicine be excluded from the list and a conclusion on GMP compliance obtained?
How to supplement the list of medicines after the issuance of a GMP conclusion?
If a statement of compliance is refused to be issued, when and how the next audit is carried out? Is a new application filed? Or should all non-conformities be eliminated (provision of evidence from CAPA) and re-audited? During a re-audit, only the elimination of non-conformities is evaluated or is the entire assessment procedure being redone?
How will the applicant know about the timing of the audit? Will he receive a notification that his documents have been submitted to the Inspectorate if he initially submits an application to the Ministry of Industry and Trade? How quickly will inspection dates be scheduled?
- Information about the schedule and the changes made to it is posted on the official web-sites of the authorized body and authorized institution on the Internet within 3 business days from the date of its preparation or changes to it.
- The authorized institution within 3 business days from the date of approval of the schedule notifies a foreign manufacturer or its authorized representative on the timing of an inspection and the need to conclude an agreement defining the inspection procedure and the associated costs, rights and obligations of the inspectors and the foreign manufacturer (hereinafter – the agreement), as well as the need to pay within 20 business days from the date of the agreement expenses related to the inspection by an authorized institution in the amount determined by the agreement, but not exceeding the maximum amount of inspection fees approved by the authorized body, calculated on the basis of the methodology approved by the authorized body.