Custom Processing Services




 
 
  • cGMP
    • “Good manufacturing practices” or “GMP” are practices and systems required to be adopted in pharmaceutical manufacturing, quality control and quality systems covering the manufacturing and testing of pharmaceuticals or drugs, including active pharmaceutical ingredients, foods, pharmaceutical products, etc.

      (Adapted from Wikipedia) Click here for more information.

  • excipient
    • /ex•cip•i•ent/ (ek-sip´e-int): any more or less inert substance added to a drug to give suitable consistency or form to the drug; a vehicle.

      Source: http://medical-dictionary.thefreedictionary.com/excipient Dorland’s Medical Dictionary for Health Consumers. © 2007 by Saunders, an imprint of Elsevier, Inc. All rights reserved.

  • ICH Q7A
    • the officially accepted Active Pharmaceutical Ingredients (API) Good Manufacturing Practice (GMP) Guidance that was drafted by the International Conference on Harmonization (ICH) and officially adopted by the three regions of the world that are signatory to the ICH, namely the EU, Japan, and the United States of America.

Food and Pharmaceutical Services

CPS food and pharma plant

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.