- 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.
- Risk analysis and risk management;
- Assessment of the impact on the product quality;
- Assessment of criticality of the equipment, systems and processes.
- 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.
- 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.
- 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:
- More than 20 data loggers of the physical quantities,
- More than 700 temperature sensors,
- More than 29 pressure sensors,
- More than 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.
- 30-year experience of work of Lab & Pharma, spol. s r.o. in EU and the CIS (Commonwealth of Independent States), 16-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.