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Wissen, was drin ist.


July 2016

• Electronic Submission of Approval Documents
• Water Determination by Karl Fischer
• Drinking Water Audit at GBA Laboratory Site of Phytos
• SAVE THE DATE! From Challenges to Solutions

• Management Change


Dear Reader,

welcome to the July edition of our newsletter for the pharmaceutical division of the GBA Laboratory Group with interesting and up-to-date subjects round about analytical questions.

Enjoy reading!
Your GBA Laboratory Group

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Electronic Submission of Approval Documents Will Become Mandatory: eCTD Specification v4.0 Released

by Dr. Johannes Rzepka, GBA Laboratory Group

The development towards an exclusively electronic process in the field of Regulatory Affairs is inevitably moving forward. For some time now, it is already required to submit Centralized Procedures (CP) and Human Decentralized Procedures (DCP) electronically. Since the beginning of the year, this is also mandatory in all procedures for veterinary pharmaceuticals and for the use of electronic Application Forms (eAF). Submitting Mutual Recognition Procedures (MRP) will be permitted exclusively in electronic format starting in 2017. The latest reports from the German BfArM state that the electronic procedure will be made compulsory even for domestic procedures starting in 2018, excluding registered homeopathic treatments. Submitting a baseline for existing approvals is recommended, but it will not be required.

Present limitations to the current eCTD specification, however, make a larger revision necessary. This concerns the management of individual documents, as well as links to other applications and submissions, among other issues.

In April 2016, a new eCTD specification v4.0 was published for the purpose of developing, testing, and commenting. The ICH decided to make the Health Level 7 (HL7) Standard a common technical basis, both for the Individual Case Safety Reports (ICSR) and for the eCTD v4.0. In doings so, the specifications described in the eCTD v4.0 draw upon experience that was gained from the first version of the Regulated Product Submission (RPS) standards, so it is also referred to as an RPS-HL7 standard.

RPS and eCTD both want to establish a single, standardized format for regulatory submissions. The RPS standard offers two clear new features as compared to eCTD:

•  For the first time, RPS enables two-way communication between the 
    applicant and the authorities.
•  RPS will facilitate the lifecycle of applications by allowing previously submitted
    information to be cross-referenced. Previously submitted information does not
    need to be repeated in a completely independent application process either. 
    The concept of “context of use” will be implemented for this and they will be
    matched with the respective documents.

All industry norms aside, the users will be interested to see what effects these developments have in practice. So far, that cannot be foreseen, because first the software companies and developers have to react to these reforms.

If you have any questions about this or other topics in the field of pharmaceutical approval processes, then please contact your individual customer service representative at the GBA Laboratory Group, or:

LPU Labor für Pharma- und Umweltanalytik GmbH
Dr. Johannes Rzepka
Tel: +49 (0) 89 858967-0


Water Determination by Means of Coulometric Karl Fischer Titration

by Eva-Maria Mattmer and Dr. Matthias Plöscher, GBA Laboratory Group

The exact determination of even the smallest amounts of water plays a large role in numerous pharmaceutical formulations. A suitable method for quantita­tive water determination, Karl Fischer titration, was already developed over 80 years ago. An extremely precise determination of the water content is carried out in a water-free medium, using an electrochemical reaction based on iodo­metry. Originally, the determination involved the volumetric addition of a reagent containing iodine, which meant a high amount of samples and reagents were needed. Whereas in the further developed method of coulometric Karl Fischer titration, the iodine that is generated in situ is then finely dosed and thus con­siderably smaller amounts of water can be determined precisely with a lower sample demand.

Testing pharmaceuticals often proves to be relatively complicated. In general, it involves complex compositions and compounds. The underlying reactions of Karl Fischer titration can be disrupted by certain side reactions, especially from aldehyde and ketone. The effects of such side reactions cannot be ignored. They can result in significant errors in the results of the water content.

Such side reactions can be avoided by chemical methods, especially in combi­nation with technical solutions. The applicability of chemical methods alone is often limited and developing analytical methods frequently proves to be com­plex. Technical solutions involve using an oven that heats the water present in the sample (including water of crystallization). The water released in the pro­cess is then directly transferred into the titration cell and measured.

Using these indirect methods provides several advantages. The oven tech­nology can be automated well and not only enables an increased sample throughput, but also raises the robustness of the method. This has a positive effect on the validation of methods and saves time. The inspection of the titration device in accordance with Pharm. Eur. can also be automated, which helps facilitate the routine operational qualification of the device. Furthermore, using the oven technology can minimize the demand for reagents, since the titration medium can be utilized for a higher number of measurements (usually > 10). The risk of contaminating the measurement cell is also reduced, as it does not come in direct contact with the sample material.

The GBA Laboratory Group Pharmaceutical Division offers the corresponding analyses with a modern coulometric Karl Fischer titrator combined with an oven at our Location in Martinsried, LPU Labor für Pharma- und Umweltanalytik GmbH. If you have any questions about this topic, then please contact your individual customer service representative at the GBA Laboratory Group, or:

LPU Labor für Pharma und Umweltanalytik GmbH
Dr. Franz Menzinger
Tel: +49 (0) 89 899 229 - 0

[1] Karl Fischer Titration – Determination of Water, Eugen Scholz, Springer Verlag Berlin, Heidelberg, New York


DAkkS Drinking Water Audit with LabWare LIMS at GBA Laboratory Site of Phytos in Neu-Ulm

by Dr. Angela Paul and Dr. Berthold Lausecker, GBA Laboratory Group

On May 11th 2016 at the GBA Laboratory Group’s location in Neu-Ulm, Phytos, the quality management system, DIN EN/ISO 17025:2005, was once again inspected by DAkkS (Deutsche Akkreditierungsstelle GmbH). The inspection was intended as a complete system audit of the company’s existing procedures for the implementation of DIN/ISO requirements for microbiological testing of drinking water, including sampling.

In addition to intensively scrutinizing the processes of our microbiological department, the main focus of the inspection was on data collection and processing using the newly launched LIMS (Laboratory Information and Management System) created by the company LabWare. With the introduction of this LIMS, the processes in the department can be significantly accelerated and made more robust. From creating offers to placing orders, sample entry and processing, all the way to quality control of the results and generating reports and invoices, every process step is managed using a single system.

The audit was completed successfully and the auditors recommended that the accreditation be maintained without any restrictions. Implementing LabWare LIMS for the microbiological testing of drinking water represents yet another milestone in the GBA Laboratory Group Pharmaceutical Division.

Operating according to DIN EN ISO/IEC 17025:2005, the GBA Laboratory Group offers a complete package for drinking water testing at our location in Neu-Ulm, Phytos Labor für Analytik von Arzneimitteln GmbH & Co. KG, as well at as our location in Pinneberg, GBA Gesellschaft für Bioanalytik mbH. We combine the advantages of proximity for microbiological tests (e.g. legionella, total plate count 22°C/36°C, E. coli/coliform microbes, enterococci, pseudo­monas, clostridia, etc.) at Phytos with the expertise and long-term experience of the GBA Laboratory Group’s division for environmental analysis.

Operating according to cGMP, Phytos and LPU Labor für Pharma- und Umwelt­analytik GmbH, also part of the GBA Laboratory Group, offer a very wide range of scientific and technical solutions for the development, approval, and quality control of medicinal active agents at all stages of the product lifecycle, serving customers from both the private industry and research institutions.

Take advantage of our competent and comprehensive service, all from one source, whose excellent and outstanding quality has once again been con­firmed!

If you have questions about this or any further topics concerning our comprehensive portfolio of services, then please contact your individual customer service representative at the GBA Laboratory Group, or:

Phytos Labor für Analytik von Arzneimitteln GmbH & Co. KG
Mr. Stefan Woidich
Tel: +49 (0) 731 974 39-0


SAVE THE DATE! From Challenges to Solutions - Pharmaceutical event

GBA Laboratory Group cordially invites you to our free event “From Challenges to Solutions” hosted by our Pharmaceutical Division:

Date:           September 16th 2016
Location:    Hotel Bauer, Münchner Str. 6 in 85622 München-Feldkirchen

Take part and experience a day of presentations on the latest issues, ranging from doping to pharmaceutical process technology, and even the new legal regulations concerning GMP. These topics as well as others will be presented by well-known guest speakers.

An exciting supplementary program with sponsors from the fields of pharmaceuticals, mobility, and communication will complement the event. Besides the pharmaceutical field, we will also get you acquainted with the topic of “electromobility.” Over the course of the day you may be lucky and be able to test an electric vehicle from a well known manufacturer.

Take advantage of the know-how provided by experts – ask your own individual questions in the context of a personal conversation. Use the opportunity to share your experience or just to network with colleagues.

If you are curious about this event you will find further information about the program as well as a registration form here.

We are looking forward to greeting you personally at our pharmaceutical event! 


Phytos GmbH & Co. KG: Management Change at the GBA Laboratory Group Location for Pharmaceutical Analysis in Neu-Ulm

On May 23rd 2016, Mr. Andreas Cramer and Dr. Berthold Lausecker became the managing directors authorized to solely represent Phytos Labor für Analytik von Arzneimitteln GmbH & Co. KG. Andreas Cramer (52 years of age, degree in sales), who is responsible for human resources throughout the entire GBA Laboratory Group, will take on responsibility for the Sales Department of Phytos. Dr. Berthold Lausecker (59 years of age, degree in chemistry), as the site director of the GBA Pharmaceutical Division in Neu-Ulm, will be responsible for the operative business and available for you as a point of contact.

Marco Zeller, the previous managing director of Phytos, will assume the task of scientific and regulatory external communication for the Pharmaceutical Division of the GBA Laboratory Group. In this role, he will represent the company externally, working in direct cooperation with the Marketing & Sales Department. We owe him our gratitude for all the work that he has done for us as managing director of this site.

With this new structure, we are available to provide you with even more competent support for your analytical matters. We are looking forward to continuing our good cooperation.

Phytos Labor für Analytik von Arzneimitteln GmbH & Co.KG
Dr. Berthold Lausecker
Tel: +49 (0)731 97439-0

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