Hedinger, founded in 1843, manufactures and distributes excipients in the pharmaceutical industry, only under GMP/GDP conditions, from its plants located in Germany (Stuttgart, where the central offices are located, and Teutschenthal, near Leipzig).
Both plants are GMP certified by the local German authorities, and have 9 clean rooms (ninth clean room still under construction) where all pharmaceutical excipients are repackaged.
From its two GMP laboratories, all operations can be officially certified in accordance with European, American or Japanese pharmacopoeias.
Thanks to its state-of-the-art facilities, which are reinvested in on a yearly basis for continual improvement according to its quality policy, Hedinger can offer its manufacturing clients more critical specialties (biological, biosimilar, and injectable preparations), excipients with microbiological control, and endotoxins subjected to strict quality controls, in addition to a specific parameter analysis, adapting to the needs of the client. This is evidenced by the fact that the most renowned manufacturing laboratories have placed their trust in them for the management of their excipients.
Its catalogue of products covers both liquid and solid excipients, all coming from globally recognised manufacturers, subjected to extra quality-control processes and / or purification, which makes them stand out when compared with the cosmetic and technical standards normally found on the market, and for this reason they are of the highest quality available within the pharmaceutical industry.
- Standard: IPEC/PQG GMP for Pharmaceutical Excipients; ICH Q7a
- Periodic audits carried out by technicians and scientists at their facilities
- Audit Reportsfrom providers available for consultation in situ by our clients.
DEDICATED BULK TRANSPORT
- Transport of liquid excipients in dedicated tanks for each product to avoid any chance of contamination.
- Certification of the tanks and associated teams, and a training program for drivers.
- Certification and audits for primary packaging manufacturers (only new packaging used)
- Control checks on receipt and dispatch of primary packaging and possibility for complete tracking.
- Certified labelling system
REPACKAGING IN CLEAN ROOM
- 9 clean rooms, 100,000 class (class D)
- Certification in accordance with EU GMP
- Routine control of particles and microbiological monitoring
- Large number of staff specifically trained for Hedinger (scientists, pharmacists, engineers)
ANALYSIS AND BATCH RELEASE
- Complete analysis of all batches according to GMP and COA, signed off by qualified person
- 2 GMP laboratories, certified by the competent German authorities
- Implemented methods: Ph. Eur. / USP / JP
- Robust control process and OOS investigation
- Certification of reference standards
- Batch release by the qualified person (QP), in accordance with GMP regulations
REDUCED CONTROL ANALYSIS ON RECEIPT FOR MEDICATION MANUFACTURERS
- Through a quality agreement with its clients, the Hedinger COA allows a reduced control analysis on receipt for its excipients (EU-GMP Part 1 Chap. 5). This results in a significant reduction of costs for our.
- Sampling of all of our products is available, carried out by a dedicated team and by qualified staff.
- Documentation in accordance with GMP (SOPs, records etc.)
- Retained samples from each batch.
- Stability studies (for almost all products) according to ICH Q1a and in different types of primary packaging
- Specific and personalised stability studies
- Reports in accordance with ICH Q1e
- Environmental conditions according to ICH (where necessary)
- In-house Analysisof relevant parameters