The highest level of quality is pivotal for our and your success. As a cornerstone of our business, quality manifests itself through our integrated quality assurance system, quality control procedures and testing methods. GMP and GLP certified and FDA approved with over 30 years analysis experience we offer the knowledge and techniques to support your exact requirements in accordance with European and FDA quality standards.
Statement of GMP compliance
QUALITY ASSURANCE SYSTEM
Defined by comprehensive, well-structured standard operating procedures, our Quality Assurance (QA) system guarantees that all analyses are traceable, from the sample receipt to the performance of the study and reporting of results. Incorporation of current FDA and EMA requirements ensure that our QA system is constantly updated. Regular inspections by the authorities and audits from our customers confirm the high level of compliance with the current GMP and GLP regulations.
Current procedures for OOS results, deviation handling and CAPA management form an integral part of our QA system. Before changes are implemented, their impact on quality must be evaluated; corresponding measures are laid down and processed.
The success of our Quality Assurance system rests on the knowledge and dedication of our highly trained, long-standing staff. Ongoing training and knowledge transfer between project leaders and laboratory staff is core communication tactics in helping to ensure that our QA system has the trust and respect of our clients. All work is performed with qualified instruments. Our documentation is comprehensive and thoroughly controlled. GMP/GLP documents are archived for at least 15 years.
A Site Master File according to EU ‘Site Master File - Explanatory Notes’ is available on request.
INSPECTIONS AND AUDITS
To supervise the compliance of our quality assurance system, regular inspections and audits are performed at SYMBIOSIS.
Operating within a GLP framework we are familiar with periodic self-inspections – experience gained over many years. Our policy for the performance and documentation of internal inspections is laid down in SOPs. In addition a yearly program defining time lines and inspection areas is followed by our QA personnel.
Routine inspections by authorities monitor the compliance of our QA system with cGMP and GLP. Furthermore our QA system is regularly supervised by our national and international clients according to their requirements.
Observations from audits and inspections result in corrective and preventive actions, continually improving our QA system.