Validation
&
Qualification

• Complex validation services for the existing and newly constructed pharmaceutical plants.

• Performing the qualifications of clean rooms, technological equipment, systems and processes.

• Fields of Activities:

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

Lab&Pharma validation, s.r.o.

• Lab & Pharma validation, s.r.o. was created by separating the validation department from the existing company Lab&Pharma, spol. s.r.o.
• A team of specialists with state-of-the-art instrumentation and experience in performing validations and qualifications since 1991. More than half of the specialists have been in the team for more than 15 years.
• 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.
• When working we follow ISPE documents, European and national GMP rules, pharmacopoeias, technical standards and recommendations of other profession organizations. We have experience with FDA requirements.
• 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.

Our services

Clean room validation

• Preparation of validation documents (protocol, report).
• Performing the qualification tests and evaluating the results.
• Air balancing of HVAC systems.

Equipment, system and process qualification and validation

• Preparation of validation documents (protocol, report).
• Performing the qualification tests and evaluating the results.
• Process optimization.
• Product validation.

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.

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.

Risk control

• Risk Analysis.
• System Classification (ISPE).
• System Risk Assessment (ISPE).
• Contamination Control Strategy (Annex 1, 2022).

Design and purchase

• Preparation of User Requirement Specifications – URS.
• Design review and qualification – DQ.
• Technical Support in FAT/SAT.

Commissioning, testing and balancing of engineering systems

• Preparation of commissioning testing documents and performing the tests.
• Air balancing of HVAC systems, balancing of clean media systems.
• Assessment of the scope of the activities performed within commissioning by the supplier, check of the testing performed by the supplier.

Temperature mapping

Calibration

GMP Consulting

Design and supply of monitoring systems

• Environmental monitoring.
• Temperature monitoring.
• Clean media monitoring.

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.
• 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.
• 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

Czech Republic

Slovakia

Belgium

Bulgaria

France

Lithuania

Germany

Poland

Romania

Sweden

Other

Belarus

Great Britain

Kazakhstan

Russia

Switzerland

Tunisia

Ukraine