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ARCO® QUALITY

We consider our company to be a high quality contract partner for the manufacturing of soft gel capsules meeting the requirements of our branch. Our QM manual reflects our quality assurance system, containing among others defined SOP’s (Standards Operation Procedures). They are based on the latest EU-GMP rules and are subject to regular internal and external audits.

Low hierarchical structure , the regular training of our staff as well as our principle: "Quality is given priority" guarentee the high quality standard of our products which we feel committed.

QUALITY ASSURANCE

Under quality assurance and quality control we mainly comprise

  • fixed procedures

  • qualification and validation

  • documentation of the QS system

  • quality and quantity check on receipt of goods

  • control in process during manufacturing

  • documentation of process

  • filing of remaining samples

  • check and release of the finished product


Standard parameters are i. a. as follows

  • check uniformity of the filling product

  • disintegration (Ph. Eur. 2.9.1) and microbiological analysis (Ph. Eur. 2.6.12 and 2.6.13) of total number of germs, yeast and mould absence check of E. coli

  • with regard to our quality control and assurance traditional wet-chemical procedures as well as modern chromatography (HPLC, GC) and spectroscopic methods (UV-Vis, IR, photometry) are used.

QUALITY POLICY

One of our most important management challenge is to realize and to agree on our quality targets.

  • our main aim is to have satisfied customers which can be reached by offering them high quality products and services.

  • the management makes sure that all resources necessary to realize the QM are made available.

  • each member of staff is responsible for the quality in his sector.

  • whoever discovers a fault or defact is obliged to eliminate it or to inform his senior.

  • prevention of faults is given priority to elimination.

  • the quality of our products reflects the qualification and skills of our staff.

  • to reach our targets the general manager transfers this authority to his senior staff managers.

  • our quality principles and the procedures described in our quality manual are binding for the whole staff.

CERTIFICATION

Further activities such as the modernization and adaption to the latest QM innovations are of high priority for us.