Quality
Top priority: Absolute safety and high quality
For 1az Pharm, patient and drug safety is the top priority. Our customers can rely on the fact that we have consistently implemented the requirements of the Delegate Regulation (EU) 2016/161 for the protection of German pharmaceutical distribution against the entry of counterfeit medicines.
The 1az Pharm packs have a first opening protection (anti-tampering-device, ATD for short) as well as an individual recognition feature (unique identifier) and can be verified via the securpharm system.
At the same time, our internal system for creating serial numbers has been validated. In addition, all materials used, such as folding boxes, labels or the ATD are continuously qualified. In this way we ensure the quality of these materials over the entire life of the preparation.
The correct labelling of 1az Pharm preparations is continuously monitored and coordinated with the responsible supervisory authorities such as EMA, BfArM, PEI and the marketing authorisation holders (original manufacturers).
Batch release certificates from the PEI are available for all preparations in the portfolio such as monoclonal antibodies, immunoglobulins and vaccines.
Guide to drug safety for 1az Pharm products:
Our drugs are purchased from approved wholesalers in countries of the European Union. All countries of the EU can be considered as supplier countries. Further details are regulated by the corresponding marketing authorisation of the European Medicines Agency EMA or the parallel import authorisation of the BfArM. If these requirements are met, the relevant preparations are obtained from eligible wholesalers after qualification and approval by the supplier.
In order for such a wholesaler to be considered as a pharmaceutical supplier for us, there must be basic minimum requirements . If necessary, further evaluations are carried out.
All pharmaceutical suppliers are classified in risk classes after evaluation and are continuously listed in the "Approved Pharmaceutical Suppliers" list.
Our incoming goods inspections cover the following criteria:
- Supplier qualification
- Temperature control for chilled goods
- Testing for counterfeits
- PEI release
- Recall from original manufacturer
- Proper initial storage