Quality Management

EXCELLENCE IN PRODUCT DEVELOPMENT & QUALITY ENGINEERING

ARCO relies on high-quality raw materials, certified quality, modern production technologies, optimized workflow planning and process control and offers all relevant packaging solutions in-house. In variable batch sizes and with guaranteed completion dates that only an owner-managed family business can offer.

We meet or exceed all quality criteria that apply to nutraceutical or pharmaceutical products. Keywords such as GMP, HCCP, MSC, Serialization, Track&Trace, EFSA are not foreign words to us, but part of everyday life.

We have an independent quality assurance system. Our facilities are certified according to EU GMP regulations, International Food Standard, Global Standard for Food Safety, EU Organic Regulation (2092/91/EG).

The European Food Safety Authority (EBL) is at the heart of the European Union (EU) risk assessment of food and dietary supplement safety.

At ARCO, we always work within a full understanding of EFSA‘s requirements and we can assist our customers with every step required for a product claim to be effective in accordance with regulations and guidelines.

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.

The high level of our quality assurance system is reflected in our quality assurance manual and includes, among other things: predetermined defined SOP (Standard Operation Procedures). These are based on the requirements of the current EU GMP guidelines and are subject to regular inspection, on the one hand through in-house and on the other through external authority audits.

Our flat hierarchical structures, the regular training of our employees and our principle that quality with us
It is a matter for the boss to guarantee the high quality standard of our products, to 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.

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