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12.01.2017
Disposal of Insulating Materials Containing HBCD – German Government Grants Deferral
In our September 2016 newsletter, we reported on the ban on the production and circulation of products containing over 100 mg/kg of the flame retardant hexabro­mocyclododecane (HBCD). more

Furthermore, as of September 30th, 2016, materials containing over 1,000 mg/kg are no longer allowed to be recycled. Instead, they should be destroyed in muni­cipal waste incineration plants in accordance with Art. 7 (2) of the POP Regulation (EC) No 850/2004.

In certain German federal states, however, the application of the regulation tends to impede rather than promote the desired method of disposal. In some cases, the material cannot be incinerated due to its classification as “hazardous waste” (e.g. in cement plants in Rhineland-Palatinate). Moreover, many waste management com­panies and incineration plants either cannot accept this waste anymore or only at excessive prices, because this waste doesn’t fit within their logistical concept or the functionality of the facility. Due to this, housing companies in particular have prob­lems disposing of the insulating material in accordance with the legal require­ments.

Therefore, on December 16th, 2016, based on a proposal from Saarland, the Ger­man Bundesrat decided on a draft to amend the regulation on the European List of Waste. It is indisputable that HBCD is hazardous to the environment and must be removed from circulation. However, in order to counteract this problem, a one-year exemption should be issued for materials containing HBCD. This is meant to allow for a sustainable solution to be found, for a concept to be generated, and, where necessary, for the waste incineration plants to be upgraded appropriately. Nevertheless, it is not intended to mean that materials contain HBCD should once again be classified as nonhazardous. The exemption merely serves to help meet the legal requirements for disposing of these materials in the future.

For years, the GBA Laboratory Group has been conducting analyses of a wide range of organic and inorganic flame-retardants in diverse matrices. In addition to testing heat insulation and electronic products, we also analyze these substance groups in sediment, water, soil, and biota samples, even at trace levels. Furthermore, we follow the latest developments on the market for you, so that we may continue to support you with competent advice and service.

[1] www.gba-group.de/en/newsletter-englisch/newsletter-0916-gba-laboratory-group-online-version/
[2]
www.bundesrat.de/SharedDocs/downloads/DE/plenarprotokolle/2016/ Plenarprotokoll-952.pdf?__blob=publicationFile&v=2
 

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19.12.2016
New Chairman of the DVGW Hanover Office from the GBA Laboratory Group
Over the next four years, the chairman of the board of the DVGW Hanover office will be provided by the GBA Laboratory Group. At the general assembly on Novem­ber 29th, 2016, Dr. Sven Steinhauer from our location in Hameln was promoted to be the successor of the long-term chairman of the four-person board, Hans-Jürgen Pütz. In the next four years, the focus will be on continuously supervising the indivi­dual members as well as conducting interesting events on the topics of water and gas in the region. more

This will be carried out in cooperation with the surrounding local offices as well as the Hamburg office, which is responsible for the DVGW Regional Office North ().

The DVGW – Deutscher Verein des Gas und Wasserfaches e.V. / German Technical and Scientific Association for Gas and Water) – promotes technology and science in the fields of gas and water. For more than 150 years, the DVGW has been advoca­ting for safety and quality standards for gas and water, providing a platform for sharing interdisciplinary technical experience.

The DVGW...

• Develops the recognized technical standards for gas and water
• Inspects, certifies, and monitors products, persons, businesses and
   quality management systems (QAS, QMS) in the fields of gas and water
   technology 
• Initiates and supports innovative and practical research projects
• Provides information and training on a full range of topics in the field of gas and
   water technology.
• Hosts important conventions and conferences

Further information can be found here: .

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14.11.2016
GBA Will Be an Exhibitor at the “QM! Jahres-Konferenz” 2016
The first Behr’s Akademie “QM! Jahres-Konferenz” (QM Annual Conference) will take place on November 29th and 30th, 2016. It is targeted towards quality managers from the food industry and trade. The two-day program is designed to address current topics in the field of quality assurance: more


• Reliably determining country of origin and identity
• Declarations of conformity
• Harmonizing IFS, BRC, FSSC, ISO
• Food packaging
• Foreign objects
• Managing impurities and allergens
• Transparency, authenticity, food integrity
• Personal liability

The program will be rounded out by a visit to the Frankfurt airport, with a chance to gain insight into the work conducted at the border control point.

The GBA Laboratory Group will also take part in this event as an exhibitor. It is our ongoing duty to compare the services that we offer with the current legal developments. Furthermore, we offer our customers and other companies in this field of business the opportunity to discuss their concerns with us directly.

If you have questions for us, Mr. Adalbert Elmers and Dr. Sven Steinhauer will be available in person during the conference. If you are unable to participate in the QM! Jahres-Konferenz 2016, or if you have special questions, please contact your individual account manager at the GBA Laboratory Group, or:

GBA Gesellschaft für Bioanalytik mbH
Dr. Sven Steinhauer
Tel: +49 (0)5151 / 98 49-0

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01.11.2016
All Lab Services GmbH, Vienna, Acquires b.a.r.b.a.r.a. Engineering, Consulting, Research & Service GmbH in Leoben, Austria
In October this year, the GBA Laboratory Group’s joint venture project, All Lab Services GmbH, based in Vienna, succeeded in acquiring b.a.r.b.a.r.a. Engineering, Consulting, Research & Service GmbH, located in the city of Leoben, in the Styrian region of Austria, as a further expansion to our service portfolio in the field of environmental analysis. more

b.a.r.b.a.r.a. is an independent service-provider that emerged in 1990 from the research, environmental technology, and raw material technology of the largest Austrian steel company. The company functions as a chemical and microbiological laboratory, as well as a technical office for environmental protection, and is also qualified as an accredited testing and inspection site. In their services for the industry as well as for both municipal and commercial operations, the main focus is on environmental analysis, expert assessments, and studies concerning all topics related to the environment. Services related to environmental hygiene, drinking water analysis and appraisal, as well as consulting services for businesses and environmental facilities complete the profile. b.a.r.b.a.r.a. offers support through quality assurance, training seminars, and inspections. Taking all our competent partners into account, our comprehensive and interdisciplinary range of services is rounded out by the research and development tasks provided by b.a.r.b.a.r.a., particularly in the industrial sector.

For All Lab Services GmbH, this expansion represents not only an increase in laboratory space, but also a broadening of the product range for processing environmental samples. Furthermore, with the GBA Laboratory Group, additional synergies can be utilized in order to provide our customers in Austria with a very extensive range of services in the field of environmental analysis and engineering.

We are happy to welcome our new colleagues in Austria at b.a.r.b.a.r.a. Engineering, Consulting, Research & Service GmbH as a member of All Lab Services GmbH and thus also to the GBA Laboratory Group.

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22.09.2016
GBA Laboratory Group to Hold Lecture at the Concept Heidelberg Seminar: “Regulatory Compliance Expert”
CONCEPT HEIDELBERG will hold an advanced training seminar on the topic “Pharmaceutical authorization for people working in a GMP setting” in Karlsruhe on October 20th and 21st, 2016. With Dr. Johannes Rzepka, Head of the Regulatory Affairs Department at our location in Gräfelfing – LPU Labor für Pharma- und Umweltanalytik GmbH – the GBA Laboratory Group provides a highly competent lecturer who will present on the topic: “Information from the GMP environment for the application dossier: analysis and quality control.” more

Before a medicinal product is allowed to be placed on the market, its quality, efficacy, and safety must first be documented within the context of the authorization process. Declarations must be made concerning the production, the content of the active ingredient(s), purity, and stability. These include, for example, items such as specifications, justifications, and reference standard monographs.

If you have any questions, Dr. Rzepka is also available to answer them outside the context of the seminar. If you are not able to participate in this seminar on pharmaceutical authorization, or if you have any particular questions, feel free to contact us by email: info(at)gba-pharma.de

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20.09.2016
GBA Laboratory Group Now Represented in Governing Body of the VUP
The GBA Laboratory Group is now represented within the governing body of the German Association for Independent Test Laboratories (VUP – Deutscher Verband Unabhängiger Prüflaboratorien e.V.). At the general assembly on September 8th, 2016, Dr. Andreas Hofmann from our location in Neu-Ulm – Phytos Labor für Analytik von Arzneimitteln GmbH & Co. KG – was elected to the five-person team. The focus for the next two years will be placed on strengthening the attractiveness and the clout of the laboratory association, which has grown strongly in recent years. Especially in terms of politics, government agencies, and public relations, more should be done to represent the needs and interests of the members, which now comprise over 600 businesses. Furthermore, the service for the members will be improved continually. more

VUP represents the interests of the licensed service laboratories in Germany. About 80% of the companies in the sector are members of this business association. The members conduct chemical, physical, and biological analyses and offer expert consulting and appraisals. The association was founded in 1994 and is based in Berlin. Further information about the association can be found at: www.vup.de.

 

 

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19.09.2016
GBA Laboratory Group to Hold Presentation at CPhI 2016 in Barcelona: EU-Import from Non-EU-Countries, Our Concept and Our Solutions to this Challenge
In a second presentation, also as part of the Insight Briefings at the CPhI 2016 in Barcelona, the GBA Laboratory Group’s Pharmaceutical Division will explain some of the special aspects of the European pharmaceutical market. Marco Zeller, a representative from our location in Neu-Ulm (Phytos Labor für Analytik von Arzneimitteln GmbH & Co. KG) will present potential solutions for how business from non-EU countries can tap into the European pharmaceutical market. The European Union, which currently has 28 member states, is still a growing market for the sales of pharmaceuticals. Europe accounts for 25% of the worldwide pharmaceutical sales revenue, and yet the market continues to grow (approx. +4% in 2015). Due to the increasingly aging demographic structure, rising costs in healthcare services, and combined with high quality standards, the healthcare system is increasingly being put under pressure. Pharmaceutical companies from outside the EU (e.g. India, China, USA) have been increasingly observing this situation and in the meantime they have started targeting this market commercially. Often, these non-EU companies enter the market through a selected EU member state. At the moment, Germany, the Netherlands, France, and the UK are the preferred countries for this. The expansion to further EU countries ensues progressively after being granted authorization and building up the marketing and sales organization. Due to the complex authorization procedures and regulatory requirements in the EU, companies from non-EU countries often are stretched to the limits of their capabilities. more

Our pharmaceutical division’s locations in Neu-Ulm (Phytos Labor für Analytik von Arzneimitteln GmbH & Co. KG), Gräfelfing, and Martinsried (LPU Labor für Pharma- und Umweltanalytik GmbH) offer one-stop shopping for all your analytical needs: comprehensive consulting, analytical and mi-crobiological analyses, complete registration services, and QP services for market authorization.

Depending on the market entry plan and the product, the GBA Laboratory Group provides you with competent and flexible support with both the centralized and decentralized authorization proce-dures and compiles all of the necessary documentation (e.g. eCTD). Following a gap analysis (due diligence), any potential gaps (e.g. validation, stability studies, establishing reference standards, Q3D risk assessment) will be identified, evaluated, and if necessary, closed.

When the authorization is granted and available, a Qualified Person (QP) from the GBA Laboratory Group conducts the qualification of the entire supply chain. If necessary, this includes auditing the production facilities of the active ingredients or pharmaceutical products, even in India, China, the USA, etc., as well as the transportation routes, packaging facilities, storage and distribution centers, and also checking their conformity with the authorization documentation and the pharmacovigilance system being used. The complexity of the supply chain determines the contractual regulations and the clearance of the pharmaceutical responsibilities that are necessary before PHYTOS, as a GMP-certified establishment with a manufacturing authorization, is able to released the product (whether a medicinal product for human use or an investigational product) for market authorization according to § 13 par. 1 of the German Medicinal Products Act (AMG). As further services, PHYTOS offers analytical method transfers, analytical and microbiological testing, importing pharmaceutical and investigational medicinal products to the EU according to § 72 par. 1 of the German Medicinal Products Act (AMG), as well as the usage of pharmaceutical storage facilities compliant with GMP.

With competent project managers, long-term experience in the analytical field and with authoriza-tion procedures, as well as a wide-ranging analytical portfolio, the GBA Laboratory Group is the competent partner that can reliably accompany you through the entire process, from the application to the authorization and bringing your product on the market.

Meet us in person at the CPhI 2016 in Barcelona: Wednesday, October 5th, 2016 (4:30 – 5:15 p.m.), Theater One

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