Schott’s Fiolax glass tubing plant in Gujarat, India, has recently achieved official Good Manufacturing Practice (GMP) compliance. 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.
Schott manufactures glass tubing in Europe, South America and Asia, with a total production capacity of more than 140,000 tons.
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, Quality Management at Schott Tubing. Hennig continued, “It is therefore established practice for Schott to work as per GMP standards at all our facilities.”
“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.
He further stated, “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.”
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.
Schott India through its manufacturing sites in Gujarat and two sales offices in Mumbai and Pune also saw promising growth in the fiscal year 2013-2014. Schott’s join venture in India, Schott Kaisha earned business through its market leading products such as Type I tubular glass prefillable syringes, cartridges, vials and ampoules which picked up significantly.
Schott intends to continue on its course to sustainable and profitable growth in fiscal year 2014/2015 by increasing its worldwide group sales and EBIT by 2 to 3 per cent. Specifically for the Indian market, Schott Kaisha is planning to launch some high-end, innovative products, which will be disclosed soon. “Our target for this year, where we complete 25 years of operation, is to upgrade the existing technology at our plant in Jambusar, Gujarat, to enhance quality and output of its production,” said Kairus Dadachanji, managing director of Schott Kaisha.
Schott Kaisha was established in 1991 as a premium manufacturer of pharmaceutical containers made of neutral glass in India under the name Kaisha Manufacturers Pvt. Ltd. In 2008, it started cooperation with the international technology group Schott. The Indo-German joint venture is a leading supplier for the pharmaceutical industry offering solutions for the entire range of small volume tubular glass parenteral packaging including ampoules, vials, cartridges and sterile prefillable glass syringes.