At Weifa, well-proven quality systems govern activities across the value chain – from the reception of raw material to the distribution of finished products. We systematically build quality into all steps of the process and into the mind-set of all employees.
Weifa operates in a strictly regulated industry where high quality standards represent a licence to operate. On top of the fundamental requirements, Weifa builds quality as a competitive strength towards consumers as well as professional partners. Our fundamental belief is that you cannot control your way to quality. It has to be built into all steps of the process and into the mind-set of all employees. Quality is therefore a key organisational concern, not only the responsibility of quality professionals.
The imperatives of pharmaceutical production
Quality assurance is about building robust systems and ensuring compliance with key regulatory documents. The primary focal point of Weifa’s quality work is the production plants in Kragerø, Norway. Both plants are certified according to GMP (Good Manufacturing Practice). In addition, the metformin plant is inspected and approved by the US Federal Drug Administration (FDA). Documented training in procedures is performed for all levels of personnel. All processes are governed by a so-called SOP (Standard Operational Procedure), an essential tool in ensuring predictable correct quality. Other key documents include the Site Master File, which represents the formal licence to produce, and the Validation Master Plan, which specifies everything that needs to be in place in terms of processes, equipment and information systems. Further attesting to its quality, analysis takes place according to the European Pharmacopoeia, a recognized common standard for use by healthcare professionals and others concerned with the quality of medicines. The production of metformin granulate, an ingredient in products sold in the US, is also governed by the US Pharmacopoeia.
Special quality aspects at Weifa
Weifa’s general plant in Kragerø is a multi-purpose facility, meaning that the same equipment is used for the manufacturing of different products. This requires special precautions to guard against cross-contamination, both in synthesis and preparation of finished products. Stringent cleaning procedures and systematic laboratory analysis are essential.
In the API market, Weifa serves the international pharmaceutical industry in competition with producers operating from low-cost countries. Through a focus on quality and know-how, Weifa has managed to establish a stronghold in these markets. An example is Weifa’s reputation for providing among the purest and best free-flowing qualities of metformin hydrochloride in the market. Quality also extends beyond product characteristics. We work hard to build and maintain quality at the customer end of the value chain for finished products – also known as good distribution practice.