Questions and Answers

In this section, you can find answers to frequently asked questions.

1. How can I find out the date when the test protocol will be issued?

You can find out the planned date for the issuance of the test protocol in the Customer's personal account. To do this, you need to register on the FARMOBORONA Research Center LLC website.
You can also send a request by email to client@farmoborona.ru, indicating the relevant request in the subject line.

2. Is it possible to conduct tests without providing samples?

Testing without samples is not possible. You can get information about the number of test samples and materials required for analysis by email at client@farmoborona.ru by providing the regulatory document.

3. Is it possible to conduct accelerated tests for the parameters “Sterility” and “Microbiological Purity”?

According to the requirements of the State Pharmacopoeia of the Russian Federation, the duration of the test for the “Sterility” parameter is 14 days, and for the “Microbiological Purity” parameter – 5 days. Accelerated testing is not possible.

4. Is it possible to conduct a “Microbiological Purity” test on a single package of a medicinal product (MP)?

According to the requirements of the State Pharmacopoeia of the Russian Federation OFS. 1.2.4.0002.18, for each batch of MP under study, the required number of samples is taken in accordance with the category of the product from a sufficient number of different packages (at least 3–10); for aerosols based on liquid or solid substances, 10 containers are taken, for transdermal patches – 10 patches.

In some cases (if the product is expensive and/or the batch volume is small), the sample may be reduced in individual cases to 2–3 g (ml). Reducing the sample size and specifying the test method must be justified and approved in the regulatory documentation as prescribed.

5. Does Roszdravnadzor (RZN) accept test protocols issued by your laboratory?

Yes. In accordance with Federal Law No. 449-FZ of November 28, 2018, manufacturers of medicinal products (except for immunobiological medicinal products) or organizations importing medicinal products into the Russian Federation submit to the federal executive authority performing control and supervision functions in the field of healthcare a test protocol for a medicinal product of a specific manufacturer (for one batch of each trade name, taking into account the dosage form and dosage), conducted by testing laboratories (centers) accredited in accordance with the legislation of the Russian Federation on accreditation in the national accreditation system.