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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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19.09.2016
GBA Laboratory Group to Hold Presentation at CPhI 2016 in Barcelona: ICH Q3D – Elemental Impurities: Our Concept and Our Solutions to this Challenge
As part of the Pharma Insight Briefings at the CPhI 2016 in Barcelona, Dr. Andreas Hofmann, from the Pharmaceutical Division of the GBA Laboratory Group, will hold a presentation on the funda-mentals and the requirements of the ICH Guideline Q3D, “Elemental Impurities.” He will illustrate suitable solutions for various forms of pharmaceuticals, using current cases as examples, and will also present our comprehensive range of services in this field. According to the Guideline ICH Q3D, since June 2016, for all new applications for authorization, a risk assessment for the pharmaceutical in question must be submitted along with the CTD documenta-tion. The new guideline does not exclude pharmaceuticals that are already authorized. For all authorized pharmaceuticals that are currently available on the market, this assessment must be submitted to the marketing authorization holder and be available to the supervisory authorities by December 31st, 2017. more

The approach of this guideline represents a complete paradigm shift. The responsibility for ensuring the pharmaceutical’s perfect quality in terms of “elemental impurities” is now entirely borne by the authorization holder. Moreover, it is a comprehensive approach that comprises all aspects of production (excipients, API, container closure systems, drug product) under GMP requirements. Then, if necessary, suitable corrective measures should then be derived from the risk assessments in order to elevate and ensure the quality of the pharmaceutical product. Particularly for smaller and medium-sized companies, that potentially could entail tremendous efforts for their staff, financial expenses, and logistical issues, since they may lack the required expertise in these fields or the appropriate concepts for solving these issues.

The GBA Laboratory Group’s pharmaceutical site in Neu-Ulm – Phytos Labor für Analytik von Arz-neimitteln GmbH & Co. KG – has developed a simple and practical concept based on an approach that mixes the options mentioned in the guideline for creating the risk assessment. It mainly focuses on Option 3 stated in the guideline: “Test Final Drug Product.” At the outset, matrices are generated for the customer, e.g. shared excipients, suppliers, subcontractors, production processes, etc. in order to identify overlaps in the customer’s individual product range and avoid excess efforts and costs. Furthermore, product groups are also identified that can be evaluated in combination.

As one-stop shopping for all your analytical services, 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 comprehensive consulting, analytical and microbiological testing, complete registration services, and QP services for market authorization.

In the analytical field, the GBA Laboratory Group also provides all of the required services (ICP-MS screening processes, verification of methods, validation of methods, batch testing) under cGMP conditions.

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 throughout the entire process of monitoring elemental impurities.

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

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15.09.2016
ABF Pharmaceutical Services GmbH in Vienna is New Member of the GBA Laboratory Group Pharmaceutical Division
This year in July, we successfully acquired ABF Pharmaceutical Services GmbH, located in Vienna, Austria, as an expansion to our Pharmaceutical Division and its service portfolio. ABF is an internationally operating company with more than 10 years of experience in the production and logistics of clinical trial supplies and central lab supply services. ABF’s comprehensive range of services also includes services in the fields of GMP consulting, GMP audits, import/export, QP consulting, QP release, QA consulting. The company’s customer base consists of large pharmaceutical producers but also medium-sized or smaller biotech companies and CROs. more

In addition to acquiring another location in Austria, for the GBA Laboratory Group, this expansion represents an opportunity to take advantage of further synergies, enabling us to provide our customers with an even more comprehensive range of services: the one-stop shop for analytical services.

Take a look for yourself at: www.abf-pharma.com.

We are delighted to have new colleagues in Austria and we gladly welcome ABF Pharmaceutical Services GmbH to the GBA Laboratory Group.

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09.08.2016
We’re moving!
In order to increase the laboratory’s capacity, GBA Laboratory Group’s administrative departments (eg. customer service, personnel department, etc.), located at the headquarters in Hamburg-Harburg, are moving to a new building at Harburger Ring 17 in 21073 Hamburg (Harburg). Therefore our staff will have limited telephone and email access on August 18th and 19th 2016. The work in the laboratory will not be affected by the move. more


Please accept our apologies should there be any minor delays on these days.
This spatial expansion is our response to the market demands for quicker processing times and higher sample throughput. In the following weeks the space now vacant will be further expanded for microbiology and residue analysis so that we can continue to meet the higher demand.

Your GBA Laboratory Group

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06.05.2015
Analysis of Ninhydrin-Positive Substances According to Ph. Eur. 2.2.56 – Testing by Verified Methods
The test for ninhydrin-positive sub­stances in Ph. Eur. monographs for amino acids has been updated from thin layer chromatography (2.2.27) to the test with an amino acid analyzer (2.2.56, Method I). more


Since the middle of 2014, the test according to Ph. Eur. 2.2.56 is conducted within the GBA Laboratory Group Pharma under the quality standard GMP. The methods can be used as routine procedures and are verified for each monograph that is already modified.

Please, contact our sales representatives for questions and quotes related to this service and further services.

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