EXCIPIENTS

Hedinger

Hedinger, founded in 1843, makes and distributes excipients in the Pharmaceutical Industry in accordance with the GMP/GDP from its two plants located in Germany (Stuttgart, where the central offices are located and Teutschenthal, near Leipzig).

Both plants are GMP certified by local German authorities and contain nine clean rooms (the ninth clean room is currently being built) where all of the pharmaceutical excipients are re-packaged.
From the two GMP laboratories, the operations can generally certify that its operations are in line with the European, American and Japanese Pharmacopoeias.

Thanks to the state of the art facilities, which are reinvested in annually per the Quality Policy, Hediner can offer its most critical manufacturing clients (biologists, biosimilars, injectables) excipients with microbiological tests and endotoxins subjected to specific analysis parameters adapted to the needs of the client. Proof of this can be seen by fact that the most renowned manufacturing laboratories have placed their trust in us for the management of their excipients.
The product catalogue includes both liquid and solid excipients, all stemming from globally renowned manufacturers, subjected to an extra quality control and/or purification process that differentiates us from the technical and cosmetic grades usually found in the market, making these the highest quality available in the pharmaceutical industry.
l

PROVIDERS QUALIFICATIONS

  • Standard: IPEC/PQG GMP for Pharmaceutical Excipients; ICH Q7a
  • Periodical auditings performed by managing technicians and scientists in the facilities
  • Audit reports by available providers to consult in situ by our clients

TRANSPORT OF DEDICATED BULK

  • Transport of excipient liquids in product specific tanks to avoid any and all possibility of contamination.
  • Qualification of tanks and associating teams and driver training program.

PRIMARY PACKAGING

  • Qualification and auditing of the primary container manufacturers (only newly used containers)
  • Entry and release of the primary containers and possibility of complete tracking.
  • Certified labeling system
V

REPACKAGED IN CLEAN ROOM

  • Nine 100,000 class clean rooms (class D)
  • Qualifications in accordance with the EU GMP
  • Routine particle control monitoring and microbiological surveillance
  • Elevated number of personnel specifically trained in Hedinger (scientists, pharmacists and engineers)
i

ANALYSIS AND RELEASE OF BATCHES

  • Complete analysis of all of the batches in accordance with the GMP and COA signed by the technical manager
  • 2 GMP laboratories certified by the competent German authorities
  • Implemented methods: Ph. Eur. / USP/ JP
  • Robust control process and research of OOS
  • Qualification of reference standards
  • Batch release by the qualified person (QP) according to the GMP

REDUCTION IN ENTRY CONTROL ANALYSIS’ FOR MEDICAL MANUFACTURERS

In agreement with client quality compliance, the Hedinger COA allows for a reduction in entry control for its excipients (EU-GMP Part 1 Chap. 5). This possibility translates to significant cost reductions for clients.
d

SAMPLES

  • Samples are available of all of our products made by our committed team and skilled personnel.
  • Documentation in accordance with the GMP (SOPs, records, etc…)
    Retained sample of each batch.

STABILITY STUDIES

  • Stability studies (for almost all the products) in accordance with ICH Q1a and in different types of primary packaging
  • Specific and personalized stability studies
  • Reports in accordance with the ICH Q1e
  • Environmental conditions in accordance with the ICH (when necessary)
  • In-house analysis of relevant parameters.

TRUST IN GLOBALK QUÍMICA

High Quality Providers