Manufacturing and Quality Control
When it comes to ensuring quality and superior product manufacturing, Grünbiotics believes anything but complete adherence to quality standards is not acceptable. This belief is further heightened when our final products help improve the lives of people with serious disorders (such as Alzheimer’s dementia and major depression).
Because quality control (QC) is a core strength of Grünbiotics, our trusted products are recommended worldwide by doctors, pharmacists and other healthcare professionals.
Quality Control and Medical Foods
As Grünbiotics’ products are Medical Foods, quality control standards are extremely high. In markets around the world, Grünbiotics’ products are categorised as “Food for Special Medical Purpose” by the Codex Alimentarius Commission – FAO-WHO/UN, Australia and New Zealand, the European Union and China, “Medical Foods” in the United States, “Foods for Special Dietary Uses” in Canada and “Food for Specified Heath Uses” in Japan.
Our quality standards are more specific than that of normal foods. That is, both Medical Foods and pharmaceuticals are used to help people suffering from serious disorders, disease and medical conditions. Medical Foods are used by specific people who cannot meet specialised nutritional requirements from their normal diet. Functional foods and nutritional supplements, however, are developed for healthy individuals to help maintain wellbeing.
Quality Control (QC) & Management
Grünbiotics’ partners ensure our product manufacturing is robust. Our partners perform significant quality checks, carrying out comprehensive analysis of manufacturing practice and integrating quality control techniques into the entire manufacturing process.
Our QC processes identify shortcomings / problems in both pre- and post-production, focusing upon three critical components, including:
Inspection and analysis of raw materials
Inspection and analysis of the final product
Management of the Quality Control (QC) process (including such aspects as process improvement and traceability)
Our QC system ensures verification of the strength, safety and stability of our products. Our partners test and analyse an array of manufacturing components, some of which include:
Raw materials
Incoming materials
Material stability
Harmful materials
Heavy metal
Microorganisms
Pesticides
Quality Control (QC) of Partners
Our key partners are approved, registered and audited companies. At Grünbiotics, we partner with those who have state-of-the-art manufacturing processes and facilities, including:
Merck KGaA
With 350 years of developing products and services in the areas of Healthcare, Life Science and Performance Materials, Merck KGaA focuses on “accuracy, reproducibility and compliance”, providing “products with an unrivalled range of specifications and accreditations, which comply with numerous global standards.”
Mylan
Grünbiotics has also teamed up with Mylan in Australia who “applies one global quality standard” … that “begins with product development, as we work to ensure an acceptable safety and efficacy profile for every drug we hope to market, and it extends through every step of the production process, from making or sourcing raw materials to producing finished dosage forms.”
Our partners implement Standard Operating Procedures that are continuously audited, monitored, reviewed and updated. Quality Control test results are also reviewed by Grünbiotics internal experts and external consultants.
Our Expertise
The Grünbiotics’ leadership team has expertise in the biotechnology and medical industries. Together, this expertise and commitment to quality also ensures other areas, such as analytical testing methods used, monitoring programs, documentation and continuous improvement practices, are state-of-the-art and best-in-class.
Quality Standards
Our QC partners’ manufacturing processes guarantee national and international quality standards are achieved. Products are tested to required regulatory standards in those markets Grünbiotics sells to (Asia-Pacific and Europe). Certificates of Analysis are also supplied. Apart from these regulatory standards, Grünbiotics ensures quality is based upon industry association guidelines, NGOs and customer needs and expectations.
To find out more about Grünbiotics’ manufacturing and QC Program, please contact us:
Telephone: +613 8692-0006
E-mail: info@grunbiotics.com