VALIDATION

Validation and Qualification

Existing Enterprises

New Enterprises

Specialists of Lab & Pharma from Ukraine have been engaged in validation activities since 2005

The company performs a wide range of validation works related to:

Pharmaceutical manufacture

Biotechnological manufacture

Veterinary manufacture

Storage and distribution of medical and veterinary products

Manufacture of medical gases

Manufacture of medicinal devices

Manufacture of equipment for pharmaceutical and medical industries

Laboratories

Health Care Facilities (surgical units, resuscitation and intensive care units, patient isolation rooms, centralized sterilization departments, and others)

Manufacture of electronic components

The company has at their disposal:

Team of own highly professional specialists

Years of experience in different countries

Knowledge of modern standards, using advanced methods

Тhe company has its own validation equipment, that allows simultaneous working on several facilities

Тhe company has a Calibration Laboratory that has accreditation with ISO/IEC 17025, which provides qualified preparing of the validation equipment

Possibility to increase (in times) the validation groups and validation equipment for performance of works of large volumes in short terms, reducing the production stop time

Necessary certificates

For the existing facilities, we offer:

Technical audit of qualification facilities

Calibration of measuring instruments:

Pressure sensors

Temperature sensors

Humidity sensors

Conductivity sensors

Other measuring instruments

Performance of regular requalification (OQ/PQ), in particular:

Development of all necessary documentation

Analysis and proposal of the volume and periodicity of the requalification

Performance of all qualification tests

Assistance in resolving identified deviations

Process (product) Validation, Aseptic Process Simulation (media fills)

Cleaning Validation, in particular:

Development of all necessary documentation

Risks Analysis of cross-contamination

Determination of the degree of risk

Calculations of permissible amounts of residual substances

Toxicological assessment

Optimization of cleaning processes

Development of Contamination Control Strategy

For the new facilities and after reconstruction, we offer:

Development of Validation Master Plan, in particular:

Definition of strategies, scope and ways of carrying out of validation

Planning of validation works at the facility: Development of User Requirement Specifications (URS), Risks Analysis, Design Qualifications (DQ), FAT/SAT, commissioning and qualification of all stages, Process Validation

Other important parts

Development of User Requirement Specifications (URS)

Risks Analysis in different directions of pharmaceutical manufacture

Design Qualification (DQ), in particular:

Decisions determined by the design documentation

Systems and equipment that will be manufactured

Calibration of measuring instruments

Pressure sensors

Temperature sensors

Humidity sensors

Conductivity sensors

Other measuring instruments

Qualification IQ/OQ/PQ, in particular:

Development of all necessary documentation

Provision of necessary validation equipment

Performance of all qualification tests

Assistance in resolving identified deviations

Process (product) Validation, Aseptic Process Simulation (media fills);

Cleaning Validation, in particular:

Development of all necessary documentation

Risks Analysis of cross-contamination

Determination of the degree of risk

Calculations of permissible amounts of residual substances

Toxicological assessment

Proposal for cleaning processes

Consultation (training) of the customer's personnel

Development of Contamination Control Strategy

Development of quality system documentation (Standard Operating Procedures, instructions, manuals, etc.)

The company specializes in qualification:

Clean rooms and HVAC systems

Isolators and other Barrier systems

Laminar air flow units, zones of directed airflow

Biological (microbiological, cytotoxic) safety cabinets

Technological equipment (systems) for manufacture of active pharmaceutical ingredients

Technological equipment (systems) for manufacturing radiopharmaceuticals products

Technological equipment (systems) for manufacturing sterile and non-sterile products:

Liquid forms

Solid forms

Semi-solid, soft forms

Gaseous forms

Equipment of Laboratories

Equipment of Health Care Facilities

Qualification of technological equipment is performed for the following objects (but not limited to them):

Weight systems

Systems of raw materials preparation

Steam, dry-heat and superheated water sterilizers

Ethylene oxide sterilizers

Equipment for decontamination by hydrogen peroxide

Depyrogenation tunnels

Washing machines

Solution preparation systems and other preparation systems

Reactors, fermentors

Centrifuges

Filling machines

Filling lines

Freeze drying machines;

Blow-Fill-Seal machines (BFS systems), Form-Fill-Seal machines (FFS systems)

Micronizers, calibrators

Mixers, homogenizers

Compactors;

Extruders

Fluid bed dryings, drying cabinets

Tablet presses

Capsule filling machines;

Coaters

Inspection machines

Packaging machines

CIP, SIP systems

Process media systems:

Water for injection (WFI)

Purified water (PW)

Pure steam (PS)

Compressed air (CA), nitrogen, other technological and technical gases.

Stability test chambers, thermostat chambers, refrigerators, freezers, cryosystems

Warehouse facilities

Cold chains

Computerized control systems

Systems of critical parameters monitoring

Special systems and equipment

Issuing of documentation in Ukrainian, English and Russian languages

The enterprises we worked for

We provide only a part of the enterprises where we worked and provided services. We treat absolutely all our customers and partners with great respect, and we are ready to give the full reference of the company on your request

VALIDATION

Validation and Qualification

The enterprises we worked for

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