R-Pharm Germany GmbH
Heinrich-Mack-Str. 35
89257 Illertissen

Telefon: +49 7303 12-0

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Titelbild Analytik

Agility. Know-How.

Quality is more than a standard in Illertissen, whether in in-house production or as a contract manufacturer. Our aim is to ensure quality systematically already within the process and to embed supreme standards as a contribution for process excellence. Naturally, all documentation / data reporting is done in accordance with current GMP guidelines.

Analytical Services

QA Services

Quality Control

Analytical Services Quality Control the good feeling to be on the SAFE side

Our Quality Control Division with 40 qualified laboratory staff members supports you in the development, optimization and quality control of your products with an extensive portfolio.

Detailed Services:

  • Analysis and release of pharmaceutical active ingredients, excipients and medicinal products in accordance with the pharmacopoeial monograph, customer specifications or registration documents
  • R-Pharm Germany GmbH holds a manufacturing authorization for the release of medicinal products according to § 14 AMG (German Drug Law). This allows us to have the approved tests conducted in the R-Pharm GmbH Germany Laboratory certified by a qualified person upon request according to § 15 AMG. The QP in charge at our customers’ side may refer to this laboratory certificate as per Annex 16 of the EU-GMP Guideline – and thus reduce the workload for the batch release of the medicinal product
  • State-of-the-art method optimization for HPLC / UPLC methods for assay- or purity determination as well as dissolution methods
  • Method development and validation of all dosage forms according to ICH guidelines or customer specifications
  • Lab-to-Lab-transfer [method transfer] / ISPE guidelines, including planning and reporting
  • Analysis of highly active substances in our safety lab

Stability Studies

Stability Studies

Analytical Services Stability Studies Trust is good,
Control is better

We are happy to advise and support the planning of necessary stability studies including custom-made test plans. Furthermore, we can store your samples and take over the entire sample management.


  • Advice and support in the planning and creation of stability studies according to ICH guidelines
  • In-use stability, photo-stability, stress tests
  • Complete data- and sample management including scheduling and sample shipping

Your stability samples will be stored under the various climatic conditions in modern climate chambers with continuous monitoring:

  • Climatic zone I / II: 25°C/60% r.h.
  • Climatic zone III / IVa: 30°C/65% r.h.
  • Climatic zone IVb: 30°C/75% r.h.
  • Accelerated: 40°C/75% r.h.
  • References: 5°C


Quality makes the difference

QA Services Release good to have
unlimited market opportunities

For companies beyond the European economic area we offer to perform analysis (EU-Gate Testing) to support the EU-batch release.

Quality Oversight

QA Services Quality Oversight Quality Oversight

We are happy to take over the quality supervision of your GMP / GDP processes and act as a contact for complaints, change controls, evaluations and documentation. Benefit from our established systems and key figures based on regulatory requirements.

Quality system related

  • Quality Agreement
  • Proof of Concept (QA Systems, SMF, Quality Manual, SOPs)
  • GMP Training of Quality Systems
  • Support for Document creation (Site Master File, Quality Manual, Validation protocol / report)

Regulatory related

  • Artwork Services
  • Establishment Registration & Drug Listing

EU QP Services

  • Batch Certification

Auditing related

  • Mock Audit (EU GMP compliance, solids)
  • Supplier Qualification (Initial Audit, Re-Audit, Monitoring)

Quelle: https://germany.r-pharm.com/services/Quality

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