International Regulations impose different requirements for GMP compliance of starting materials. To comply with the differing requirements Hedinger carries out all manufacturing processes according to IPEC PQG GMP Guidelines, IPEC GDP Guidelines and EU GMP Part II:
- Manufacturing of Highly Purified Water Ph. Eur. / Water for Injection USP
- Manufacturing of Purified Water Ph. Eur. / USP
- Preparation of aqueous starting materials solutions
- Packaging of starting materials
- Labeling of containers
Customer specific requirements may be agreed and implemented for any of the points 3. - 5. above.