+420 272 101 411 labpharma@labpharma.cz

Validation
&
Qualification

A Wide Spectrum of Services in Validation and Qualification

More than 400 qualified machines, systems or processes per year

Existing facilities

Newly constructed facilities

Our experience

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Wide range of services in validation and qualification for customers in the following areas:

  • Manufacture of medicinal products and active substances.
  • Manufacture of medical devices.
  • Laboratories.
  • Medical facilities.
  • Clean rooms.

Validation Department Lab&Pharma

  • The main equipment necessary for efficient qualification testing, in sufficient numbers, e.g. 12 particle counters for clean room measurements, 500 temperature probes and 20 validation systems (64 channels) for data acquisition.
  • Ability to perform qualification of many machines and systems at once and to reduce the time needed for production plant shutdown.
  • Communication and document preparation in English, Czech and Russian.
  • If a defect or other problem is found, we will ensure correction or necessary technical support.

What we offer for the existing facilities

  • Regular Requalification (IQ/OQ/PQ).
    • Proposal of requalification scope and frequency.
    • Performing the qualification tests and evaluating the results.
    • Assistance in resolving the deviations found during qualification process.
    • Preparation of validation documents (protocol, report, test forms).
  • Cleaning Validation.
    • Risk analysis of cross contamination of medicinal products for human and veterinary use, and nutritional supplements.
    • Preparation of validation documents.
    • Sampling and sample analysis.
    • Review and optimization of the existing cleaning process and cleaning validation.
  • Calibration of Measuring Instruments.
  • Balancing of the existing HVAC systems.
  • Consultancy in the field of GMP, technological equipment, clean rooms, critical parameter monitoring and in other fields of pharmaceutical production.

What we offer for newly constructed facilities and reconstructions

  • Preparation of Validation Master Plan.
    • Definition of validation strategy, scope and method of validation of a new facility (plant).
    • Planning of all phases: URS, System Risk Assessment, DQ, commissioning, qualifications (IQ/OQ/PQ), validations.
  • Preparation of User Requirement Specifications – URS.
  • Technical Support in Manufacturing Equipment Selection.
  • System Classification and System Risk Assessment.
  • Design review and qualification – DQ.
    • Verification that the project/equipment/system has been designed in compliance with the design task specification, URS, GMP requirements, risk assesment results or other standards.
    • If some shortcoming is found, proposal for the change of the design.
  • Technical Support in FAT/SAT of manufacturing equipment.
    • Check of the scope of the FAT/SAT activities proposed by the supplier company.
    • Technical support in performing FAT/SAT.
  • Commissioning, testing and adjustment (balancing) of engineering systems.
    • Preparation of commissioning testing documents and performing the tests.
    • Adjustment (balancing) of HVAC systems and clean media systems.
    • Assessment of the scope of the activities performed within commissioning by the supplier, check of the testing performed by the supplier.
  • Qualification (IQ/OQ/PQ).
    • Proposal of the scope of qualification
    • Performing the qualification tests and evaluating the results.
    • Assistance in resolving the deviations found during qualification.
    • Preparation of validation documents (protocol, report).
  • Cleaning Validation.
    • Risk analysis of cross contamination of medicinal products for human and veterinary use, and nutritional supplements.
    • Proposal of cleaning process incl. proposed best cleaning solution; proposal and elaboration of methodology for residue monitoring.
    • Preparation of validation documents.
    • Sampling and sample analysis.
  • Product validation, media fills.
  • Calibration of measuring instruments.
  • Consultancy in the field of GMP, technological equipment, clean rooms, critical parameter monitoring and in other fields of pharmaceutical production.

Extensive experience in qualification of

  • Clean rooms (GMP, ISO-14644).
  • Laminar air flow units.
  • Isolators.
  • Barrier systems.
  • Microbiological and cytotoxic safety cabinets.
  • HVAC systems.
  • VHP sterilization and biodecontamination.
  • Manufacturing equipment.
    • Steam, dry-heat and superheated water sterilizers.
    • Ethylene oxide sterilizers.
    • Depyrogenation tunnels.
    • Washing machines.
    • Solution preparation systems.
    • Reactors, fermentors.
    • Filling machines.
    • Freeze-dryers.
    • Inspection machines.
    • Solid dosage forms.
    • Packaging machines.
  • CIP/SIP systems.
  • Clean media systems.
    • Water for injection (WFI).
    • Purified water (PW).
    • Pure steam (PS).
    • Compressed air (CA), gas distribution systems.
  • Stability test chambers, thermostat chambers, refrigerators.
  • Temperature-controlled storage areas.
  • Computerised systems.

Countries where we worked

The European Union (EU)

Czech Republic
Slovakia
Belgium
Bulgaria
France
Lithuania
Germany
Poland
Romania
Sweden

The Eurasian Economic Union (EAEU)

Russia
Belarus
Kazakhstan

Other

Ukraine
Tunisia
Switzerland
Great Britain

For download

Certificate

ISO 9001:2016 validation (EN)

Photo gallery of our jobs

Our customers

The companies we have been working with for 20 and more years

The companies we have been working with for 10–20 years

Other references

More than 80 hospitals, pharmacies, IVF centers and other medical facilities.

Contact

Validation Department of
Lab&Pharma, spol. s r.o.

RNDr. Martin Hüttel, Ph.D.

Validation Department Director

Address

U Továren 1380/2f
102 00  Praha 10
Czech Republic

Phone

+420 272 101 450

Do you have any questions?
Leave us a message!