SCHOTT, a leading international technology group in the areas of specialty glass and glass-ceramics, has announced that its Fiolax glass tubing plant in Gujarat has achieved official Good Manufacturing Practice (GMP) compliance. GMP is an international standard in the pharmaceutical industry that brings together guidelines to ensure the quality of critical production processes.
The certificate, presented to SCHOTT by TÜV Rheinland, underlines the company’s global commitment to those standards. In fact, SCHOTT is now the only supplier of pharmaceutical tubing worldwide to be GMP certified at all its manufacturing sites.
The GMP guidelines comprise a series of general principles that must be observed during the manufacturing process. More and more countries are specifying GMP as a statutory requirement that pharmaceutical companies and suppliers of quality related components to the industry must meet.
“SCHOTT considers quality assurance central to the production of pharmaceutical glass,” explained Dr.-Ing. Karsten Hennig, director of quality management at SCHOTT Tubing. Hennig continued, “It is therefore established practice for SCHOTT to work as per GMP standards at all our facilities.”
SCHOTT manufactures glass tubing in Europe, South America and Asia, with a total production capacity of more than 140,000 tons. Tubes made of Fiolax specialty glass are the basis of many pharmaceutical packaging solutions, being converted into syringes, vials, ampoules, and cartridges. These containers need to safely store medication, sometimes for years, without compromising the efficacy of the drug, implying that the quality of glass is the key.
“In order to provide patients with safe pharmaceutical products of the highest standard, quality is top priority throughout the production value chain, “said Georg Sparschuh, president, SCHOTT Pharmaceutical Tubing, India. “GMP certificate is yet another proof that our production site ensures best quality and utmost safety measures to manufacture pharmaceutical glass. By earning GMP certification at our production site in India, we are helping our customers eliminate all potential risks from the very beginning. This helps establish confidence amongst our pharmaceutical manufacturing partners.” Sparschuh added.
SCHOTT has voluntarily introduced far stricter quality standards for its technical terms of delivery than is required in the industry. Last year, SCHOTT was appointed to Bureau of Indian Standards (BIS) to advise CHD-10 - a subcommittee of the Chemicals Department. Schott provides CHD-10 specifications and guidelines for various kinds of glass manufacturing in India, including pharmaceutical tubing, fire-safe glass, household appliances and fibre optics.