Quality Assurance

Quality Assurance
Synergyhealth

For more information on Synergy Health Pharmaceutical Laboratories (SHPL) service offerings please visit our microsite
Synergy Health Pharmaceutical Laboratories (SHPL) are committed to meeting standards in every aspect of business. The dedicated Quality Control and Quality Assurance Departments ensure that all indicators are systematically monitored as well as focusing on continuous improvement.
 
SHPL's extensive quality management system is independently certified in compliance with Good Manufacturing Practice (GMP; Commission directive 2003/94/EC, Quality control testing), ISO 9001 and ISO 13485. It also follows the US Food and Drug Administration (FDA) guidelines. Our comprehensive Site Master File (SMF) gives general information about the organisation of Synergy Health Utrecht B.V., the quality management system, the building and equipment, the documentation, the analysis process and how to handle complaints and deviations. The SMF lists all Standard Operating Procedures (SOPs) involved in SHPL’s operations, including roles and responsibilities. The quality management system is continually maintained and improved.
 
For optimum accuracy, reliability and speed, all information concerning samples and related analyses, including customer specifications and any results, is entered into our Laboratory Information Management System (LIMS). Samples and results are tracked through every stage, right up to the archiving of the results, so that their status can easily be checked at any time. At each stage, information can only be entered or accessed by authorised staff with the necessary skills and training. This system accelerates laboratory turnaround, ensures data accuracy and allows for rapid and consistent reporting.
 
Our expert technical service ensures that our laboratory equipment is qualified and regularly maintained and calibrated for optimum performance. The Technical Service also provides extensive in-house training for all our lab staff, including students on placement, making sure their technical and analytical skills are of the highest standard.
 
Meeting the needs of our customers is SHPL's top priority. We therefore encourage all our existing or prospective business partners to audit our facilities.

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You are contacting:

Synergy Health Americas Home Office

Synergy Health Americas
12425 Race Track Road
Tampa FL 33626
(USA)

Telephone:+1 (813) 891-9550

 

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