Quality

QA expertise

PROXY has many years of experience in operating within the (bio)farmaceutical industry. Analysis of raw materials (actives and excipients), utilities (water, gases), product intermediates and finished drug products is our core business for which we are GMP-certified. Analytical method development and validation is performed on a regular basis, and may also be performed under GLP-accreditation. Stability studies require climate-controlled storage facilities, which must be continuously monitored to guarantee proper climate conditions. These storage facilities enable PROXY to store and distribute small amounts of finished products, for which a GDP-license was granted. Additional regulations for certain chemicals, raw materials and finished products, require separate licenses, such as for precursors and opiates.
These licenses have been granted based on a well-defined quality system which complies with all individual requirements, but which is also efficient to manage. On average, the quality system of PROXY is audited by government officials or clients every 2 weeks, and any remarks or observations are used to update the quality system.

Training of personnel
Every new employee is trained in Safety, Health & Environment regulations and GMP/GLP quality systems. This training course includes literature studies, tours through the facilities, presentations and examinations. This training course is also available for people outside PROXY through our collaboration with the department of Life Science & Chemistry in Utrecht and Leiden
Technicians are trained further in f basic laboratory equipment applications and various aspects of laboratory techniques, such as pipetting and weighing. Training and examination in analytical calculations and use of official pharmacopoeia is also part of basic laboratory training.
For complex analytical equipment, such as GC and HPLC, an additional training is required. Equipment owners are usually trained by suppliers of this equipment to ensure hands on and state of the art knowledge. Many of these training-schemes can be offered to clients.

Analytical equipment
Reliability of analytical results is heavily dependent on the quality of analytical equipment. Full validation, i.e. installation, operational & performance calibration is performed before equipment is released for use. Regular maintenance and calibration ensures continuous availability of qualified equipment.