Know what's inside.
CD-Leiste

Pharmaceutical Analysis

Pharmaceutical Analysis

Our location for pharmaceutical analysis supports you in the development, approval process, and quality control of your products with an extensive range of services

The pharmaceutical division of the GBA Laboratory Group consists of two com­panies: LPU Labor für Pharma- und Umweltanalytik GmbH (located in Gräfelfing and Martinsried) and Phytos Labor für Arzneimittelanalytik GmbH & Co. KG (based in Neu-Ulm). These subsidiaries can draw upon decades of experience in pharma­ceutical analysis and assisting with the pharmaceutical approval process in human and veterinary medicine. Over this time, they have been able to build up a global customer by providing reliable and faithful cooperation.

Operating under cGMP with more than 150 employees and over 5,000 m2 of laboratory space, the GBA Laboratory Group’s pharmaceutical division is your “one-stop shop” for analytical services. We provide our domestic and international customers, whether from the private industry or research institutions, with scientific and technical solutions for the development, approval process, and quality control throughout every step of the product lifecycle.

With a comprehensive range of services in the analytical and regulatory fields, we offer fast, flexible, and customer-oriented solutions. Our laboratories are certified according to EU-CMP, US(FDA)-GMP, and DIN EN ISO/IEC 17025:2005 and we have a manufacturing license based on §13 (1) AMG (German pharmaceutical law) as well as an import license based on §72 par. 1 AMG and the EU Regulation (EC) No 726/2004. Take advantage of our competent all-around service in the following fields, all from one source! 

  • Method development, validation, and transfer
  • Quality control (customer-specific testing instructions, Ph.Eur., USP, BP, JP, PPRC)
  • Stability studies (e.g. ICH, VICH) and sample storage management
  • Qualification, establishment, and management of reference standards (e.g. primary standards and working standards)
  • EU gate analysis
  • Releasing human and veterinary pharmaceuticals for marketing authorization (par. §13.1, QP service)
  • Release of clinical investigational products (QP service)
  • Residue and trace analyses (e.g. elemental impurities [ICH Q3D], genotoxic impurities)
  • Microbiological Examinations (incl. drinking water analysis)
  • Registration services (e.g. eCTD, all authorization processes)
  • R&D under GMP and non-GMP Standard
  • Consulting on all aspects of analysis, regulatory affairs, and pharmaceutical strategy

PHYTOS LPU

News

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

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

Intensifying the Cooperation Between LAT and LPU: Merger Between Two Pharmaceutical Analysis Companies in the GBA Laboratory Group

Effective January 1, 2015, LAT GmbH Dr. Tittel, based in Graefelfing, merged with LPU Labor fuer Pharma- und Umweltanalytik GmbH, based in Martinsried. This step marks the start of an intense and close cooperation between the two companies of the GBA Laboratory Group, with the goal of increasing the quality and efficiency of the two labs located south of Munich in order to benefit you, our customer. more