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.
- 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.
- 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
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)
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
- 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 (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.