Information


Principles

We are guided by the following principles:

  • Priority of the Customer’s requirements;
  • Requirements of national standards, EU GMP, WHO, EMEA, PIC/S, FDA, ICH, ISO, EN, etc.;
  • Application of ISPE recommendations;
  • Our own experience - requirements may not be submitted without the preliminary analysis.


Policy

The rationale for the proposed volume (extra is not validated):

  • Risk analysis and risk management;
  • Assessment of the impact on the product quality;
  • Assessment of criticality of the equipment, systems and processes.


Quality

To ensure the quality the company:

  • Selects the staff;
  • Gives the staff regular theoretical and practical trainings;
  • Uses the written methodology, approved by the leading experts;
  • Controls and approves of the issued documentation;
  • Uses the equipment complying with the modern requirements for this type (accuracy, stability, inertness, discreteness, etc.);
  • Ensures the metrological reliability of the measuring instruments;
  • Uses the updated versions of the regulatory documents and standards.


Documentation

The documentation is prepared in the English, Ukrainian, Russian and Czech languages taking into account:

  • Customer's or our own standards;
  • Customer's requirements;
  • Use of the terminology and practice adopted in the world;
  • Emphasis is put on the efficiency and understandability.


Operativeness

One of the key factors is the possibility of the operative execution of works, namely:

  • Timely engineering services;
  • Timely validation at the object;
  • Extensive instrumentation base that allows simultaneous execution of work on several types of the similar equipment units:
    • 20 data loggers of the physical quantities,
    • More than 700 temperature sensors, 
    • 29 pressure sensors,
    • 20 particle counters with the wireless data transmission,
    • Over 200 items of the sensors and instruments for recording and measuring of various parameters in certain conditions,
  • Necessary qualified personnel.


Other benefits of working with us

  • 27-year experience of work of Lab & Pharma, spol. s r.o. in EU and the CIS (Commonwealth of Independent States), 13-year experience in the affiliated company LAB & PHARMA ENGINEERING, LLC;
  • Analysis, decision making and conducting of the correcting activities at the Customer’s object;
  • Absolute confidentiality;
  • Guarantee of the results credibility;
  • Availability of the required licenses and certificates;
  • Consulting support for the Customers in the period of the inspection and certification by the authorized agencies.