Special features PharmaLine™
- We build quality into the product, and not just testing quality
- Certificate of Origin available, Cognis is the original manufacturer
- Manufacturing according to IPEC-PQG GMP guidelines (cleaning procedures, documentation, traceability, GMP drumming facility) IPEC-PQG GMP conformity declaration
- High internal standards through integrated Quality Management to ISO 9001 and ISO 14001
- Defined raw materials, defined production lines; small production batches, prevention of cross contamination
- Analysed according to the latest Pharmacopeia`s EP and USP/NF (optionally JP/JPE), performed on each batch.
- Extensive Purity data: Residual Solvents, Microbiology, Aflatoxins, Heavy Metals, Polycyclic Aromatic, Hydrocarbons (PAH) performed on each batch
- Change control agreements
- US Drug Master Files (Type IV) available
- Right to audit, even for small quantities
- Long term contracts and commitment
- Direct delivery or selected distributors
PharmaLine™ - Available Certificates
- Certificate of Origin (Cognis is the original manufacturer)
- Genetically Modified Organisms (GMO)
- Gluten
- TSE / BSE Statement
- Residual Solvents
- OVI Statement / Dioxin Statement
- Stability Certification
- Microbiological Stability