How to prepare for Russian Inspections

Although the idea and content of GMP guidance in different countries or regions is quite comparable, there are no common global GMP regulations - and inspectors from various national competent authorities come and inspect facilities in other countries.

Inspectors from Russia come on behalf of the so called Certification Center within the Ministry of Industry and Trade (MoIT). The MoIT will - after successful inspection - issue a GMP Certificate. This certificate has been required for new submissions sincec 2016 and for renewals/ variations since 2017. No products without a Russian GMP certificate can be exported to Russia. If a site does not pass the inspection, CAPAs should be completed and a new submission with supporting documents will be required.

Request of an Inspection

When requesting an inspection, different documents (forms) will be requested by the MoIT:

• Form 1: contact details of local authority and company
• Form 2: list of recalls and complaints (2 years)
• Form 3: list of medicinal products manufactured at the site
• Form 4: Letter of Consent for conducting an inspection
• Site Master File (SMF)
• Power of Attorney
• Manufacturing authorisation
• Extract from the commercial register

All documents have to be notarially certified!

So what will they look for when they come for an inspection?

Russian inspectors seem to focus mainly on documentation review and site tours to watch the manufacturing process:

• They spend a lot of time understanding area operations, layout, temperature control in production including mapping in the warehouse.
• The focus is on understanding the processes, the equipment used and how the areas are managed, including transfer of materials between graded areas.
• Also quality systems will be reviewed including Annual Product Reviews and the respective changes communicated to MoIT versus changes listed in the APR.

Wrap up

The final wrap up at the end of the inspection will be a verbal description of observations incl. a classification (minor, major, critical). Within one week, observations that need additional clarification are sent to the company but no draft report will be issued for the site to comment in general. After 30 days, a final report is issued (the classification of the observations may have changed based on information received). However it can take several weeks before MoIT determines whether a GMP certificate is granted, based on the amount and severity of observations made.