Ensure your Compliance of Good Distribution Practice (GDP)

Quality compliance of active substances/medicinal products from storage to marketing must be ensured. In Addition to GMP (Good Manufacturing Practice), GDP specifies the guidelines for the distribution process, which ensures consistency of the high quality level a manufactured pharmaceutical product has to arrive at the consumer. …more




Update on Russian Track & Trace Regulations

Already in 2009, the Russian government built the basis for Track and Trace by releasing the law no. 381-FZ. This law regulates the fundamentals for governmental regulatory and trading activities in Russia. In 2018, Russian President Wladimir Putin signed the additional law no. 488-FZ, which mentions that serialization for all drugs and a so-called “Crypto Code” will be mandatory starting January 1, 2020. …more


Pharma Solid Knowledge Report: Automated Process Development (APD)

Quality by Design (QbD) was introduced by the American FDA in the ICH Q8 (R2) “as a new paradigm with significant effects on current and future trends in pharmaceutical development (2004).” QbD describes good practice for pharmaceutical product development and introduces concepts of design space and flexible regulatory aspects. It is a systematic approach to development, emphasizes product and process understanding, as well as process control.

To read Bosch’s mini white paper on this topic …more


Interesting Insights at the Pharma Congress Production & Technology 2019

From April 9th to 10th, the annual Pharma Congress Production & Technology will again take place in Düsseldorf. For years, this event has been known as a meeting place for the industry and is now also valued as an international forum far beyond its borders. …more



World Tour: Xelum R&D first stop in New York

Bosch Packaging Technology’s Xelum R&D for the continuous production of oral solid dosage (OSD) forms holds substantial potential: since it was first introduced to selected customers in 2018, the compact, innovative machine has attracted considerable interest. Now Bosch is taking the Xelum production platform’s ‘little sister’ on a world tour.
…more



Page 1 of 5712345...102030...Last »
Top of page