Know what's inside.


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

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:

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

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

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.

Elemental Impurities in Mar­keted Products – Risk Analyses for Products Already on the Market – A New Challenge for Your Working Capacity!
At the end of February 2015, the Euro­pean Medicines Agency's (EMA) Qua­lity Working Party (QWP) set dates for the implementation of the ICH guide­line Q3D: "Elemental Impurities in Marketed Products. Recommenda­tions for Implementa­tion*." For pro­ducts that are already marketed, it is mandatory to create a risk ana­lysis concerning the reagents, catalysts, excipients, production processes, container closure materials, etc. by December 2017, in order to be able to identify and eva­luate any elemental impurities in the product. more

This is the responsibility of the product license holder. In order to generate the analysis, the relevant information must be collected from the suppliers, any contamination must be evaluated and compared with the Permitted Daily Exposures (PDEs), and specifications must be derived. In special cases, this can also lead to changes in suppliers or processes and subsequent variations. Although this guideline generally does not apply to plant-based medications, the use of certain excipients could nevertheless make it necessary to carry out a risk analysis. 

The risk analyses must be provided in written form and must be available to pre­sent if demanded during an inspection. This requires a high level of working capacity in your registration department within a short period of time and therefore could lead to delays in the implementation of other projects.

With its pharmaceutical laboratories – LPU in Martinsried and Graefelfing and Phytos in Neu-Ulm – the GBA Laboratory Group offers you the opportunity to preserve your own resources by allowing us to handle these tasks for you.

If you are interested or have any questions about our services, our customer service representatives will gladly assist you.

*Elemen­tal Impurities in Mar­keted Products. Recommendations for Implementation.

Glass Container for Pharma­ceutical Use – Test according to Ph. Eur. 8.3 established
Taking effect on January 1st, 2015 chap­ter 3.2.1 of Ph. Eur. 8.3 for testing of glass containers has been modified referring to the autoclave that has to be used. more

The pharmaceutical laboratories of GBA Laboratory Group have implemented the method according to the modified monograph in their  labs. We are able to perform all tests required under GMP for our clients.

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

The GBA Laboratory Group Supports Up-and-Coming Scientists
At the end of March, the first of the two annual nationwide meetings for the workgroup called "Junge Lebensmittel­chemikerInnen" (Young Food Chemists, or AG JLC) took place at the University of Hamburg. more

AG JLC is a volunteer workgroup belonging to Lebensmittelchemischen Gesellschaft, LChG, (Food Chemistry Society). They not only represent the interests of young food chemists in all fields of work and training, but also offer a good opportunity to share experience among peers, to develop networks, and to get insight into the practice of the profession. The membership structure is very diverse and promotes this kind of dynamic communication. In addition to meeting undergraduate students here, you can also meet doctoral candidates, food chemists doing their internship year, as well as young professionals. The GBA Laboratory Group has gladly donated materials and funding in order to support the principles for which AG JLC stands.

The GBA Laboratory Group is among the growing analytical laboratories in Europe, highly specialized in the analysis of food, environmental samples, consumer goods, and pharmaceuticals. "Therefore it is a very special objective for us to support the next generation of scientists in this way," said Manfred Giesecke, Managing Director and shareholder of the GBA Laboratory Group. "We are always searching for qualified employees and here we have the opportunity to introduce the GBA Laboratory Group as a potential employer."

The GBA Laboratory Group wishes the young scientists all the best for their future as well as continued success with their Workgroup!

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