Consultancy and Measurements
Relying on our vast experience in the pharmaceutical, medical and IT industries, we also provide consultancy services in regard to broadly understood GxP matters and perform periodic measurements of equipment, installations and rooms.
Leveraging on our knowledge of the laws and requirements and years of experience in the pharmaceutical industry, we do:
- internal and external audits of Quality Management Systems
- API supplier audits
We prepare the clients for:
- regulatory inspections (e.g. by FDA)
- client audit
- implementation of Quality Management Systems
Following the analyses of business processes and needs, we will implement a Quality Management System which is tailored to the needs of the company and compliant with the applicable laws and regulations.
We assist in Factory Acceptance Tests / Site Acceptance Tests starting from reviewing technological and technical designs for compliance with the applicable GxP regulations, through preparing and reviewing User Requirements Specification (URS) to the preparation and reviewing of FAT / SAT documentation.
If necessary, we perform FATs / SATs on behalf of the client.
Taking advantage of our experience in qualification and validation tests, we offer various periodic measurement and calibration services, such as:
- Calibration of measuring instruments and converters (pressure, temperature, humidity, time, revolutions). We offer calibration services performed at the customer’s place, which streamlines the process and reduces its duration by a factor of three or more. Our calibration certificates indicate a properly estimated uncertainty of measurement.
- Tests of temperature and humidity distribution in storage and production facilities, archives, etc.
- Integrity tests of HEPA filters.
- Particle concentration monitoring in rooms.
- Measurements of illumination levels in rooms.
- Measurements, qualification, and requalification of HVAC stations (differential pressure, temperature, humidity; air flow; balometric measurements); simulation of automatic systems (modification of settings and adjustments through simulation of electric values).
- Qualification and requalification of incubators and climatic chambers.
- Measurements, qualification, and requalification of laminar chambers and fume cupboards.
- Measurements, qualification, and requalification of production equipment, such as mixers, homogenizers, fluidization columns, encapsulation machines, bag packing machines, suppository forming machines, blister packing machines.
- Measurements, qualification, and requalification of RMS and BMS systems.
We cooperate with accredited laboratories in the area of physicochemical and microbiological tests.
To perform the measurements and calibrations, we use our own, highly specialized measuring instruments, such as:
- Fluke 9142 calibration furnace and Pt 100 probes with calibration certificates
- Beamex MC-6 multi-calibration instrument with a pressure module (–1:20 bar), differential pressure module (± 1 kPa), and low-pressure pump
- Termo-Precyzja multichannel V/A/Ω recorder
- Sanwa multimeter
- Testo Huminator 2 climatic chamber
Leveraging on our common experience, we offer services related to the implementation of computer systems (including LIMS class systems) concerning:
- General process consultancy,
- Complete analysis of business processes,
- Preparation of Terms of Reference,
- Assistance in the review of bids for compliance with the ToR,
- Assistance in the capacity of an external Implementation Project Manager,
- Verification of project documentation at all stages,
- Participation in system acceptance testing and validation testing,
- Preparation of the guidelines for the drafting and performance of post-sale and warranty service and maintenance agreements.