Amendments to the List of Works Constituting the Licensed Type of Activity
In February 2026, the OLFARM Testing Center successfully passed an inspection by the Ministry of Industry and Trade of the Russian Federation in order to expand its license for microbiological testing, including sterility and microbiological purity testing of medicinal products manufactured in Russia and imported (Codes 1.6.1., 1.6.2., 2.1.1., 2.1.2., 3.6.2., and 3.6.3.).
In addition to the existing license for chemical (physical) and biological testing, the expansion to microbiological testing enables the OLFARM Testing Center to perform comprehensive quality control of medicinal products (substances and finished dosage forms) with certification by a Qualified Person in accordance with Good Manufacturing Practice requirements (EEC Decision No. 77). Cooperation with the OLFARM Testing Center allows clients to outsource full quality control within specifications. This approach is particularly significant for microbiological testing, which is the most sensitive and variable element of the quality control system.
The expansion of the license for the microbiological and virological testing department required comprehensive modernization of the testing laboratory, including facility reconstruction, upgrading HVAC systems, technological equipment, and improvement of the pharmaceutical quality system.
A key issue in preparing the laboratory for sterility testing was choosing between a sterile isolator and a classical cleanroom cascade (Grade B room with local Grade A zone) with a pressure differential system between adjacent areas. Despite the “isolator trend,” a comprehensive risk and economic analysis led us to choose the cleanroom cascade approach.
The advantages of this solution include flexibility, high testing throughput, a wide variety of tested products, and the high competence of personnel. From an economic perspective, establishing a Grade B cleanroom cascade and upgrading ventilation with H14 HEPA filters proved significantly less expensive than purchasing and maintaining an isolator with hydrogen peroxide vapor biodecontamination. In terms of ergonomics and personnel protection, the cleanroom cascade also offers advantages, allowing microbiologists to focus on sterility testing without the restrictions imposed by isolator gloves.
As a result, sterility testing is performed in a cleanroom cascade up to Grade B, with testing conducted in Grade A laminar airflow zones. For microbiological purity testing, bacteriological studies, cell culture work, and handling infectious agents, facilities with a cascade up to Grade D have been organized. The ventilation system is equipped with dynamic electronic control systems to maintain required pressure differentials. Ventilation and environmental monitoring systems have been integrated into the overall pharmaceutical quality system. Additionally, supporting infrastructure has been implemented, including equipping media preparation areas with Grade A laminar units, enabling the use of both commercial Petri dishes and laboratory-prepared media for environmental monitoring.
The effectiveness and correctness of these measures were confirmed by inspection of the authorized body, which served as the basis for the license expansion.
The microbiological and virological research department conducts a wide range of tests, covering both pharmacopoeial and specialized methods within quality control.
Key activities include microbiological purity and sterility testing of medicinal products, performed using both direct inoculation and membrane filtration methods. In accordance with regulatory requirements, method suitability is assessed in advance, particularly evaluating antimicrobial activity under test conditions, which is critical for products with bacteriostatic or bactericidal properties. If antimicrobial effects are present, neutralization methods are applied to ensure reliable results.
Environmental microbiological monitoring (air, surface swabs, purified water) is highly востребован among clients and can be performed either on-site by OLFARM specialists or using client-provided samples. Flexible sampling organization allows use of either client materials or OLFARM laboratory consumables, facilitating integration into existing quality systems and reducing time between sampling and testing.
Another area includes specific activity testing, such as macrophage migration inhibition assays and antiviral activity determination using cell culture methods, applied in evaluation of biological and immunobiological products.
An important element of microbiological quality assurance is culture media control, including growth promotion testing and verification of diagnostic and selective properties, ensuring reproducibility and reliability of results. The department also performs testing of disinfectants for effectiveness against microorganisms of hazard groups III and IV.
The department also conducts disinfectant efficacy testing against microorganisms of hazard groups III and IV.
Within its research activities, OLFARM regularly conducts applied R&D in microbiology.
Key areas include studies of antimicrobial activity under microbiological purity and sterility testing conditions to assess method suitability and develop neutralization approaches where necessary.
R&D is also conducted to determine minimum inhibitory concentration (MIC) and minimum bactericidal concentration (MBC), providing quantitative evaluation of antimicrobial activity and mechanisms of action.
Another important area is biotechnology research, including characterization of cell banks to confirm identity, stability, and contamination safety of cell lines used in production of biological medicinal products.
For clients using sterilizing filtration processes, the company performs validation of membrane filters using biological methods with B. diminuta strains and mechanical integrity testing to confirm sterilization efficiency. The department’s expertise enables execution of non-standard R&D studies tailored to client requirements.
Microbiological control requires significant resources to comply with GMP requirements. In some cases, outsourcing microbiological testing to a specialized center such as OLFARM is a justified solution that improves overall quality system efficiency.
Outsourcing or duplication of microbiological testing is one of the tools for implementing a Contamination Control Strategy (CSS) in pharmaceutical manufacturing. This model reduces operational costs by eliminating the need to build and maintain in-house laboratories and reducing equipment and staffing expenses.
Using a licensed contractor increases reliability of test results. From a regulatory perspective, outsourcing to a licensed laboratory complies with current regulations, including EEC Decision No. 77, and enhances trust from inspection authorities due to independent and objective microbiological control.
Considering updated pharmacopoeial requirements and Annex 1 of the EAEU GMP rules for sterile manufacturing, outsourcing microbiological testing to specialized centers like OLFARM is becoming increasingly relevant and cost-effective.
Microbiological laboratory services are widely demanded by related industries where maintaining an in-house laboratory is not economically feasible.
Veterinary Product Manufacturers
Outsourcing allows veterinary manufacturers to adapt to stricter regulatory requirements and implement unified GMP approaches ensuring standardized production and quality control.Dietary Supplement Manufacturers
For dietary supplement manufacturers, raw material input control and compliance with technical regulations are critical. With upcoming stricter quality requirements, outsourcing laboratory support becomes essential.Medical Device and Cosmetics Manufacturers
For manufacturers of injectable medical devices, medical instruments, and cosmetics, bioburden and sterility control, sterilization validation support, and environmental monitoring are essential for microbiological safety and regulatory compliance. Similar tasks apply to manufacturers of surgical instruments and sutures, focusing on microbial contamination control and sterile production conditions.