Food and Pharmaceutical Services
Custom Processing Services has recently opened a new facility dedicated to food grade and active pharmaceutical processing. This new capacity will supplement CPS’s existing pharmaceutical excipient processing abilities. The 42,000 square foot structure contains several clean rooms designed specifically to accommodate the rigorous demands of cGMP production and to enable the company to work with high-potency compounds.
CPS is following the guidelines set forth by The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), specifically ICH Q7A. CPS’s Food Grade processing conforms to part 210/211 of CFR 21 from the FDA.
Some of the manufacturing area’s features include:
- FDA-approved surfaces for efficient clean-down
- Containment tank for proper disposal of wastewater
- Positive pressure air controls with HEPA filtered air
- Dedicated laboratory for product quality testing
- Secure facility with limited access
- Shatterproof glass and lighting fixtures
- Stainless steel processing equipment
Additionally, CPS has implemented a highly-developed system of policies and procedures for the food and pharma manufacturing. In addition to expanding on some of the pre-existing procedures where required, new programs have been developed to support the further demands of cGMP processing. Some of the programs include:
- Validation—process and cleaning validations
- Allergen Control Program
- Chemical Control Program
- Food Defense Protocols
- Foreign Matter Prevention Program
- HACCP Program
- Materials Management Program
- Records Documentation
Prospective clients are invited to contact Custom Processing Services’ technical staff to explore the many ways that a “customized” solution to product development needs may be created.