The GMP Continuum approach to quality delivers the quality you need in less time and for less money
Cedarburg Pharmaceuticals’ “GMP Continuum” approach to quality has historically proven to produce superior compliance results throughout the entire API development process – from pre-clinical development through commercial API production while offering you the opportunity to save time and money by having a quality system that meets your needs instead of someone else’s.
Many contract pharmaceutical development and manufacturing companies require every project they have to meet the same quality standards regardless of what stage of the development process their customer’s project is in. It’s very important to comply with the quality standards required with each phase of your development.
However, it isn’t always necessary to meet the much higher standards associated with more advanced development phases. By requiring you to meet a single quality standard, the time and money that you spend on quality processes after what’s required are simply wasted.
Our “GMP Continuum” quality approach manages every active pharmaceutical ingredient project under a series of strict, comprehensive, GMP compliant systems that are more in depth and broader in scope than most contract API manufacturers in the pharmaceutical industry.
Cedarburg Pharmaceuticals’ quality control program ensures:
- Raw material qualifications are met and samples are retained for comparative purposes
- Final products qualifications are met and samples are retained for comparative purposes
- Method validation procedures are developed and verified
- IQ/OQ instrument calibration is completed and their performance standards are verified
- All failures for raw materials and final products are thoroughly investigated to find the cause
Cedarburg Pharmaceuticals’ “GMP Continuum” quality approach also uses a controlled document system and the controls and procedures to track and monitor the following:
- Personnel training
- Production controls
- Process controls
- Lab controls
- Holding and distribution
- Method validation
- Process validation
- Change control for pre-clinical, clinical and commercial manufacturing