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Batch release testing and EU re-tests

Conducting batch release analysis on behalf of a client is synonymous with partnership, communication, trust and control – but also with the many opportunities that become available for the design of the project.

QP-certified batch release analysis

The analytical laboratory for medicinal products DSI-pharm has a manufacturing authorisation according to § 13 AMG for testing and release of medicinal products in accordance with EMA Directive 2001/83/EC. If requested, our own qualified persons (QPs) can certify the batch release testing.

DSI-pharm’s services

  • API release testing services
  • Batch release testing services
  • GMP-certified laboratory with manufacturing authorisation for product release in accordance with Directive 2001/83/EC
  • Licence acc. to section 3 of the German Narcotic Drugs Act
  • EU re-test / import testing / import authorisation for EU product release
  • QP certification, in reference to Annex 16 of EU GMP guidelines
  • Short turnaround times thanks to standardised procedures plus clear responsibilities and defined interfaces

As a service laboratory, DSI-pharm operates as a partner, providing an extension to our clients’ workbench: we create the space and time to allow them to concentrate on their core business. For pharmaceutical companies and contract manufacturers.

Medicinal Cannabis Services

Since March 2017, general practitioners and specialists in Germany have been allowed to prescribe medical cannabis in various forms, such as flowers or extracts, for serious illnesses. Due to THC contents above 0.2 %, these products are subject to the German Narcotics Law (BtMG). The handling of these products therefore requires a BtM permit from the Federal Institute for Drugs and Medical Devices (BfArM). QSI is in possession of this permit and is therefore able to carry out analyses of cannabis/preparations.

In addition to the many analyses of the DAB and Ph.Eur. this includes in particular the determination of cannabinoid content as well as the testing for impurities (pesticide residues, mycotoxins, heavy metals, microbiology, etc.).

QSI holds a manufacturing permit according to § 13 AMG. The Qualified Person of QSI monitors the processes and can take over the batch release within the scope of the manufacturing permit.

Analytical Services

Analyses according to DAB monograph “Cannabis flos”:

  • Identity
    • A: macroscopic
    • B: microscopic
    • C: Thin-layer chromatography(2.2.27)
  • Purity
    • Foreign matter (2.8.2)
    • Loss on drying (2.2.32)
    • Cannabinol (HPLC)
  • Content by HPLC
    Δ9-Tetrahydrocannabinol, Δ9Tetrahydrocannabinolic acid, Cannabidiol and Cannabidiolic acid)

Analysis according to EP monograph “Herbal drugs”

  • Pesticides (2.8.13)
  • Heavy metals Cd, Pb, Hg, if necessary As (2.4.27)
  • Aflatoxins B1, B2, G1and G2(2.8.18)
  • Ochratoxin A (2.8.22)
  • Microbiological quality (5.1.8 B)
  • TAMC, TYMC, Bile-tolerant gram-negative bacteria, coli, Salmonella


Pyrrolizidine alkaloids

Consulting Services

Import license according to § 72 AMG

  • Support of procedure / application
  • Take on the duties and responsibilities of a qualified person

according to § 14 (1) AMG

  • Draft contract according to § 9 AMWHV for quality control
  • Support of the inspection by the authorities
  • Implementation of CAPAs

Narcotics license

  • Support of procedure / application
  • Take on the duties and responsibilities of a person responsible for narcotics according to § 3 BtMG

Tentamus laboratories in your vicinity