Qualification and Validation

Lab & Pharma offers a wide range of qualification and validation services since 1991. Professionalism and experience of our employees guarantee our companies the leading position in the market of validation services in the CIS and Eastern Europe.

As a factor directly affecting the production of high quality medicines, validation will always remain one of the essential indicators of quality and efficiency of production.

We provide comprehensive validation services for manufacturers and distributors of pharmaceutical, biotechnological and veterinary products, manufacturers of pharmaceutical, biotechnological and medical equipment, laboratories, health care institutions, food producers, manufacturers of electronic components.

FEATURES OF QUALIFICATION AND VALIDATION IN THE LAB & PHARMA COMPANIES.All validation activities are carefully planned. The guiding document on qualification and validation of the object is the Validation Master Plan. Within the scope of this document Risk Analysis is performed.

The next thing to consider when planning the process of qualification and validation is the importance of cooperation of several different specialists: technologists, engineers, metrologists, and others. Our companies form a group of specialists in different fields for specific tasks. Specialists from the formed groups develop protocols, perform tests and develop qualification and validation reports. They are managed by the company's specialists with great experience in this field.

Employees use modern high quality equipment, which is regularly calibrated in special laboratories. In the Lab & Pharma companies` own laboratories service and maintenance of measuring equipment is performed.

The Lab & Pharma companies have a wide variety of instruments and measurement tools that allow to provide services in a large scope within a short time.


QUALIFICATION AND VALIDATION AREAS OF THE LAB & PHARMA COMPANIES

Qualification - actions to verify that a particular equipment or system works correctly, and really gives the expected results.

The Lab & Pharma companies provide services for all stages of qualification:

  • Design Qualification (DQ);
  • Installation Qualification (IQ);
  • Operation Qualification (OQ);
  • Performance Qualification (PQ).


Design Qualification performed for process and laboratory equipment, systems, production lines, areas and in general plants in all areas of production of medicines and medical gases.

The remaining stages of objects qualification include:

  • Qualification of clean rooms and heating, ventilation and air conditioning systems;
  • Qualification of pharmaceutical equipment;
  • Qualification of biotechnological equipment;
  • Qualification of pharmaceutical systems;
  • Qualification of biotechnological systems;
  • Qualification of pure media systems;
  • Qualification of pharmaceutical warehouses;
  • Qualification of laboratory equipment;
  • Qualifications of medical equipment;
  • Qualification of equipment for production of medical gases.


Validation - actions that, in accordance with the principles of good manufacturing practice, prove that a certain method, process, equipment, raw materials, activity or system actually give the expected results.

The Lab & Pharma companies provide such types of validation services as:

  • Validation of the sterilization process (pharmacopoeia and non-pharmacopoeia);
  • Media fills;
  • Process Validation (PV);
  • Cleaning Validation (CV);
  • Validation of the cold chain;
  • Validation of the monitoring, the automated (computerized) control systems.


Every year the specialists of our company develop hundreds of reports on qualification and validation.

The list of activities:

Production premises

  • Clean rooms
  • Isolators and other barrier systems
  • HVAC systems

Sterilization (pharmacopoeia and non- pharmacopoeia) depyrogenation processes

  • Steam sterilization
  • Dry heat sterilization
  • Ethylene oxide sterilization
  • Formaldehyde sterilization
  • Depyrogenation
  • SIP systems

The washing and cleaning processes

  • CIP systems
  • Primary packaging washing
  • Auxiliary materials washing
  • Cleaning Validation

Pure media

  • Water for injection
  • Highly purified water
  • Purified water
  • Clean steam
  • Compressed air, nitrogen and other gases

Other production processes

Production of medicines

Production of equipment

 

 

  • Preparation of solutions, ointment bases
  • Dry powder filling, filling
  • Lyophilization
  • Decontamination of external surfaces
  • Optical control
  • Granulation
  • Homogenization
  • Tableting, coating, capsule filling
  • Blister packaging
  • Cartoner, group packaging
  • Labelling
  • Cross contamination
  • Process Validation

Sampling zones, warehouse

  • Clean rooms
  • HVAC systems
  • The zones of direct air flow
  • Chamber with special storage conditions (refrigerating, freezing)
  • The validation of the cold chain processes

Monitoring, automated control systems (computerized systems)

  • Production premises
  • Pure media
  • Production equipment
  • Production processes
  • Production storage and warehousing

Laboratories, hospitals, clinics, pharmacies

  • Clean rooms
  • HVAC systems
  • Laminar boxes, isolators, biological safety cabinets
  • Thermostats, incubators, refrigerators, freezers
  • Stabilization boxes (systems of temperature and humidity maintenance)
  • Sterilization and depyrogenation processes
  • Washing, cleaning and decontamination processes
 

Among the above mentioned services of the Lab & Pharma companies, our Customers also have the opportunity to get the service «GMP audit». This is an independent audit of the object for compliance with GMP.

The possibility of providing exclusive services from the Lab & Pharma companies is realized due to the professionalism of the team of experts, the availability of modern high quality equipment and the use of existing standards.