INDIVIDUAL AND AGILE
As a developer, manufacturer and supplier of critical raw materials, CG Pharma & Biotech understands the challenges of our partners and compliance with regulatory requirements. We accompany our partners on the path from the development stage through the clinical phases to commercial production. Our services and products are tailored to the needs of our clients and can be selected and combined on a modular basis.
OUR COMPETENCES | OUR STRENGHT
- GMP compliant liquid and solid raw materials as an ingredient, starting material or excipient
- EU-GMP certified production facility: manufacturing authorisation acc. to §13 German Drug Law
- Cleanroom environment class C/D (ISO 7/8)
- In-house production WfI and AP
- Pharmacopoeia compliant raw materials (e.g. EP,BP,USP, JP, ChP)
- In-house chemical/physical analytical laboratory
- Microbiological testing (e.g. sterility, endotoxins, RNase, TAMC/TYMC, bioburden)
- In-house GDP logistics and fleet
- „Made in Germany"
Analytics
- In-house chemical/physical analytical laboratory
- Cleanroom laboratory for in-process controls
- Testing of starting materials according to pharmacopoeia (e.g. EP, BP, USP, JP, ChP)
- Finished product testing (e.g. appearance, pH, conductivity, density, refractive index, osmolality, assay)
- Microbiological testing (e.g. sterility, endotoxins, RNase, TAMC/TYMC, bioburden)
- Stability study program (in-house/external)
Quality
- Risk management system according to ICH Q9
- Robust ISO 9001 quality management system
- EU-GMP-certified
- Manufacturing authorisation according to German | Drug Law AMG §13
- Accepted supplier qualification system
- Change control management
- Quality assurance agreements with customers
- Validated procedures and processes
- Batch record
- Batch release by qualified person (QP)
WFI | AP In-house production
- Highly purified water filled in bulk for further processing
- Water for injection (WFI) according to EP, USP
- 20,000 litre storage tank
- Production capacity: 500 l/h
- Purified water (AP) according to EP,USP
- 10,000 litre storage tank
- Production capacity: 4,000 l/h
- Continuous monitoring of water quality for compliance with the specification parameters: conductivity, pH, TOC, endotoxins, sterility, TAMC/TYMC
Packaging
- Filling in customised designed 2D- and 3D-single-use bags/manifolds from 1 - 1,000 litre (extractable and leachable data available for bag film material)
- Multiway transport/bioprocess containers for 3D-single-use bags from 100 - 1,000 litre (CG Tainer)
- Various FDA compliant packaging options for liquids: 10 - 25 litre canisters, 220 litre PE- or steel drums, 1,000 litre intermediate-bulk-container (IBC), isotainer up to 20,000 litre
- Special multiway packagings with validated cleaning concepts
Warehouse
- 3,200 pallet spaces for packaging materials, raw materials and finished products
- Temperature and humidity monitored and controlled 15°C - 25°C
- Pest control monitored
- Underground stainless steel storage tank with 30,000 litre volume for pharmaceutical solutions
- Laminar-flow sampling cabine for contamination-free sampling of raw materials
PHARMA LOGISTICS
At precisely the right time. Logistics specifically tailored to the requirements of the industry also ensure that each batch reaches its users safely and in a pure condition.
We operate with our own fleet of pharma vehicles and an assigned team. An integral part of the concept are exclusive ISO tanks, which allow for distribution without product changeovers. We also take a zero compromise approach to quality control: We generally rely on batch-related complete analyses, which we carry out before storage.
Our customers benefit from flows of goods that are in transit for them 365 days a year, 7 days a week and 24 hours a day. Always with a clearly defined goal: to have the products you want in the best quality in the right place at the desired time.
CLEANROOM PRODUCTION
- Cloakrooms
- IPK Laboratory
- Solida area
- Fluida area
- Filling
- Conveyer system
