EAEU Remote GMP Inspections — Legal Grounds, Full Procedure and Manufacturer Checklist for 2025
When inspectors stopped flying to manufacturing sites in India and China in 2020, pharmaceutical companies faced a logical question: what happens now? Good Manufacturing Practice (GMP) certificates were expiring, routine inspections were not being conducted, and registration procedures ground to a halt. A temporary solution was found quickly — remote inspections. A permanent solution turned out to be far more complex: it took five years and seven revisions of Decision No. 83 of the Council of the Eurasian Economic Commission (EEC) dated November 3, 2016 «On the Approval of Rules for Pharmaceutical Inspections» for the remote format to evolve from an emergency measure into a full-fledged legal instrument.
Let us examine what exactly has changed in the Eurasian Economic Union (EAEU) Rules for Pharmaceutical Inspections over this period, in which cases a remote inspection is now legally permissible, and what a manufacturer needs to do to prepare for one.
How the System Worked Before 2021
Initially, Decision No. 83 was built on a classical on-site model: the inspection team arrives at the manufacturing site, inspects the facilities, reviews the documentation, and interviews the personnel. A remote option was not mentioned in the text at all. The logic is straightforward: without a site visit, the inspector sees only what is shown in the documents, making it impossible to form an independent judgment on the actual state of manufacturing.
Difficulties with foreign sites existed even before this. The inspectorate of the reference member state (for example, Roszdravnadzor, the Federal Service for Surveillance in Healthcare, when Russia acts as the reference state) had to organize overseas travel, coordinate with the site, and bear the expenses. As a result, inspections of manufacturers from third countries were often delayed for months. Formally, no other method was provided for.
The pandemic year of 2020 turned a theoretical problem into a systemic crisis. The rules did not provide a basis for conducting inspections without a site visit, and each inspectorate acted at its own discretion: some froze procedures, while others made decisions based on reports from third-party authorities. There was no unified procedure.
Seven Revisions in Five Years
The first amendment to Decision No. 83 was issued on February 8, 2021 (Decision No. 7) and was directly prompted by epidemiological restrictions. It established a legal framework for a flexible response, although it did not yet contain a specific procedure for remote inspections.
Thereafter, updates proceeded at an accelerated pace:
| Date | Decision | Summary of changes |
|---|---|---|
| 08.02.2021 | No. 7 | Adaptation to epidemiological restrictions |
| 19.08.2022 | No. 127 | Actualization of requirements for inspectorates and reporting |
| 23.06.2023 | No. 66 | Technical amendments to evaluation procedures, clarification of report templates |
| 04.07.2023 | No. 74 | Approval of the Procedure for Remote GMP Inspections (Annex No. 7) |
| 12.04.2024 | No. 29 | Integration of Good Pharmacovigilance Practice (GVP) inspection rules into Decision No. 83 as an independent block |
| 06.09.2024 | No. 66* | Integration of Good Clinical Practice (GCP) inspection rules into Decision No. 83 |
| 01.08.2025 | No. 60 | Integration of Good Laboratory Practice (GLP) inspection rules; latest effective version |
*Decision No. 83 contains two acts numbered No. 66: dated June 23, 2023, and September 6, 2024. They were registered in different years and both remain valid.
Decision No. 74 dated July 4, 2023, became the turning point. Prior to it, remote inspections existed de facto as a forced practice without a clear regulatory foundation. Following this decision, Annex No. 7 was introduced, setting out the entire process from start to finish: from document preparation to certificate issuance.
Simultaneously, the scope of Decision No. 83 was expanding. From an instrument designed exclusively for GMP, it evolved into a framework document covering all major types of pharmaceutical inspections: Good Manufacturing Practice (GMP), Good Pharmacovigilance Practice (GVP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP). The final block was added by Decision No. 60 dated August 1, 2025.
When a Remote Inspection Is Legally Permissible
It is important to distinguish between two sets of rules here, as the approaches for GMP and GCP differ.
GMP Inspections (Annex No. 2 to the GMP Rules). The remote format is permitted in only two scenarios: the threat, occurrence, or elimination of an emergency situation, including epidemics and exposure to chemical, biological, or radiological hazards; or force majeure circumstances posing a threat to the life and health of inspectors due to political, medical, or other reasons.
For comparison: the international practice of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) provides for remote assessments much more broadly, including routine re-inspections of sites with a good compliance history. In the EAEU, the remote format for GMP remains an exception to the general rule. Scheduled inspections still require an on-site visit.
GCP Inspections (paragraph 5 of the GCP Rules within Decision No. 83). Here, the list of grounds is broader. In addition to emergency situations and force majeure, a third ground is added: the results of assessing the feasibility of conducting an inspection based on a risk-based approach. The GCP inspectorate may decide on a remote format based on an analysis of the specific site, without extraordinary circumstances being required.
How the Remote Inspection Procedure Is Structured
Annex No. 7 establishes a detailed procedure. To start: a manufacturer cannot «request» a remote format. The decision rests entirely with the inspectorate, which bases it on its quality system. The manufacturer can only agree once the inspectorate has made that decision.
Prior to the start of the inspection, the manufacturer is required to submit an expanded package of documents: information on product types, the number of previously conducted inspections, complaints and recalls over the past three years, information on manufacturing changes over the past three years, and Corrective and Preventive Actions (CAPA) resulting from previous inspections. If these documents are current and already contained in the Site Master File (SMF), a notification to that effect is sufficient — no re-uploading is necessary.
The opening meeting is conducted via video link. During it, the manufacturer confirms the geolocation of the manufacturing site: latitude and longitude. This is a mandatory procedural element set out in the Annex.
During the inspection, the inspectorate is entitled to view the screens of computerized systems (Laboratory Information Management System (LIMS), Enterprise Resource Planning (ERP), and others) in read-only mode, request real-time video feeds from surveillance cameras, and conduct personnel interviews via video conference. Video recording of meetings and site broadcasts is only permitted with the consent of both parties.
At the end of each day, inspectors send a list of questions and required documents by email. At the closing meeting, preliminary findings are presented. The manufacturer then has 5 business days to submit any documents not reviewed during the inspection, or such other period as agreed by the parties. The certificate is issued in the standard form with a note indicating the remote format; its validity is up to 3 years from the inspection completion date, identical to on-site inspections.
One restriction applies specifically to new sites: if a site undergoes its first inspection and the remote inspection reveals at least one critical non-conformity or more than five major non-conformities, the subsequent inspection must be conducted on-site.
What to Do
Prepare the Site Master File for the remote format. An up-to-date SMF eliminates the need to compile a separate document package when a remote inspection is initiated. Verify that it covers GMP inspection history for the past 3 years, complaints and recalls, and significant manufacturing changes.
Check the site’s IT infrastructure. Ensure a stable channel for video conferencing, the ability to share computerized system screens in read-only mode, and real-time broadcasting from cameras in manufacturing areas. The remote inspection rules explicitly require technical testing of the connection beforehand — do not skip it.
Designate an interpreter in advance. If the site’s working language is not Russian, the manufacturer is required to arrange interpretation services for the full inspection period or for requested sessions. Arranging this in advance is far easier than doing so under time pressure.
Confirm the coordinator’s readiness. The manufacturer designates a single person to accompany the inspection throughout. This person must understand the procedure: any recording of meetings and broadcasts requires both parties’ consent, the site’s geolocation is confirmed at the opening meeting, and all inspectors’ questions arrive by email at the end of each working day.
Account for the difference between GMP and GCP. If you are undergoing both GMP and GCP inspections simultaneously, the legal grounds for a remote format differ. For GMP, only emergency situations and force majeure apply; for GCP, the risk-based approach of the inspectorate is added to those grounds. These regimes should not be conflated.
The remote regime is now enshrined in law with full procedural safeguards for both parties. The issue lies elsewhere: in the EAEU, the grounds for remote GMP inspections remain significantly narrower than those for GCP. For scheduled GMP inspections of foreign sites without extraordinary circumstances, the remote format is still unavailable.
Regulatory Framework:
1. Decision of the Council of the Eurasian Economic Commission No. 81 dated November 3, 2016 «On the Approval of the Rules of Good Laboratory Practice of the Eurasian Economic Union in the Sphere of Circulation of Medicinal Products»
2. Decision of the Council of the Eurasian Economic Commission No. 83 dated November 3, 2016 «On the Approval of Rules for Pharmaceutical Inspections» (as amended on August 1, 2025, with amendments introduced by Decisions of the Council of the EEC No. 7 dated February 8, 2021, No. 127 dated August 19, 2022, No. 66 dated June 23, 2023, No. 74 dated July 4, 2023, No. 29 dated April 12, 2024, No. 66 dated September 6, 2024, and No. 60 dated August 1, 2025)
3. Decision of the Council of the Eurasian Economic Commission No. 77 dated November 3, 2016 «On the Approval of the Rules of Good Manufacturing Practice of the Eurasian Economic Union»
4. Decision of the Council of the Eurasian Economic Commission No. 79 dated November 3, 2016 «On the Approval of the Rules of Good Clinical Practice of the Eurasian Economic Union»
5. Decision of the Council of the Eurasian Economic Commission No. 87 dated November 3, 2016 «On the Approval of the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union»