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Quality

Quality is one of our core competencies.  It is reflected in the analysis we perform and the results we provide.  GMP and GLP certified as well as FDA inspected, all analytical testing at SYMBIOSIS is performed in compliance with the appropriate GxP quality standard.

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. Infrastructure and equipment are state-of-the-art and 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.

Statement of GMP compliance

Statement of GLP compliance