First Pharma Glass Manufacturer to achieve Extended GMP Quality Audit

FIOLAX ® glass tubing preserves the efficacy of medicine and reduces the risk of interaction with packaging to a minimum. Photo: SCHOTT AG

It all starts with the glass: As the pharma industry seeks to eliminate all potential risks for the patient, SCHOTT has once again raised the industry benchmark by further increasing the quality management standard of its pharma glass production. For all of its four worldwide tubing production sites, the company has been accredited with both the ISO 15378:2015 certification, which stands for the international pharma standard GMP – Good Manufacturing Practice, as well as the even stricter and more risk management-oriented Quality Management Standard ISO 9001:2015. All sites were successfully audited by TÜV Rheinland – underlining that SCHOTT has made quality assurance a top priority from the very beginning of the value chain.

Each year, SCHOTT manufactures around 140,000 tons of glass tubing in Europe, South America and Asia.

SCHOTT FIOLAX® specialty glass serves as the basis for many pharmaceutical packaging products such as syringes, vials, ampoules or cartridges. These containers need to safely store medication, sometimes for years, without compromising the effectiveness of the drug – hence, quality of the glass is vital for the health of patients.

An update for GMP
The reworked GMP guidelines comprise a series of general principles, like documentation and hygiene, which must be observed during all stages of the pharmaceutical manufacturing process. This also applies to source materials such as glass. More and more countries are specifying GMP as a statutory requirement, which must be met by all pharmaceutical companies and suppliers of quality-related components to the industry. With the integrated ISO 9001:2015 regulations, all necessary requirements for a comprehensive quality management system are covered as well. In addition, specific new demands for risk and knowledge management have been added to the industry standard´s update.

FIOLAX® is a registered trademark of SCHOTT AG.