Let’s meet at CPhI worldwide in Milan
CPhI worldwide will soon take place in Milan, Italy. For professionals from the pharmaceutical industry, attending CPhI is the most effective way to meet relevant business partners.
From 9 to 11 November experts from BioChem Labor für biologische und chemische Analyitk GmbH will also attend the fair as visitors.
Will you be there, too?
New responsibilities for narcotic drugs and precursors at BioChem
BioChem Labor für biologische und chemische Analytik GmbH has recently reported changes in responsibilities to the Federal Opium Agency of the BfArM (German Federal Institute for Drugs and Medical Devices). Read more information on the topic here.
Temporary restriction for analyses requiring work with hydrofluoric acid
Some laboratories in our analytics department will undergo modernisation measures soon. Read here which areas or analyses at BioChem Labor für biologische und chemische Analytik GmbH could be affected by this.
Increase of IT protection measures
We would like to inform about the current increase of IT protection measures at BioChem Labor für biologische und chemische Analytik GmbH.
Change in the commercial management
We would like to inform about the following change in the commercial management of BioChem Labor für biologische und chemische Analytik GmbH.
Independent quality control of pharmaceutical water according to GMP standard for your pharmaceutical production
In the latest issue of the German magazin “PharmInd”, BioChem points to its expertise in the independent quality control of pharmaceutical water. Water is one of the most frequently used raw materials for the production of pharmaceutical preparations. For the different water qualities, individual quality control requirements are specified in the pharmacopoeias.
BioChem puts two new isolators for sterility testing into operation
After the successful qualification, BioChem Labor für biologische und chemische Analytik GmbH has put two more isolators into operation for sterility testing in accordance with the pharmacopoeia. Thus, a total of four isolators, built by the laboratory technology specialist Ehret, are now available to meet the strongly increased demand for sterility testing using either membrane filter or direct inoculation method according to Ph. Eur. 2.6.1/USP <71>.
Transfer of the production of active ingredients, excipients and finished products back to the EU
Many pharmaceutical manufacturers purchase the majority of their active ingredients and excipients from non-EU countries, a majority of them from Asia. If there are quality problems in production, for example due to impurities (e.g. nitrosamines in sartans), or if production or export is stopped or there are logistical problems, the production of finished products in Europe also comes to a standstill.
BioChem determination of TOC/ TNb for water analysis and cleaning validation
The TOC value provides information about the contamination of purified water or ultrapure water by carbon-containing organic compounds
What is TOC?
TOC stands for Total Organic Carbon and is a sum parameter in water analysis. The TOC value represents the sum of the total carbon with a very low limit of detection (“LOD”) in a sample.
BioChem expert as speaker on the topic of “Remote Audits” at the APV online seminar “Challenges in dealing with COVID-19 in pharmaceutical companies”
On 26 January 2021, the Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik e. V. (APV) will offer an online seminar on “Challenges in dealing with COVID-19 in pharmaceutical companies”. One focus will be the topic of remote audits, which are currently established as an appropriate instrument to ensure compliance with quality standards.