Design Control
Design and development of new products at HyClone come under the control of HyClone’s Design Control Assessment Team (DCAT). The DCAT is a cross-functional team made up of a chairman and representatives from HyClone’s Research and Product Development, Marketing, Sales, Engineering, Operations, and Quality Control and Assurance departments.

The DCAT evaluates the viability of a project and categorizes the project based on deliverables, resource requirements, risk, and return on investment. Once a project is approved, the team assigns a project leader and champion to manage the project.

Once a new project is approved by DCAT, a Design/Development team is appointed to design and develop the new product. While the bulk of this developmental work resides in Research and Product Development or Engineering, team members are cross functional, ensuring a smooth transition from research and development through scale up, production of pilot and qualification lots, product validation and documentation. The end result is a quality product that meets customer specifications.

Production Control
HyClone’s production control processes ensure lot-to-lot consistency and product quality while establishing full manufacturing traceability for each lot. Product control documents (PCDs) transmit information from manufacturing specifications into production drivers and lot history records.

Production orders are generated within the ERP computer system where information from controlled Bills of Material merge with ordered lot sizes to generate pick lists and batch recipe documents. The PCD becomes the stepwise manufacturing record that physically accompanies the lot through production.

In addition to listing every detailed production step, the PCD includes spaces for operator responses and sign-offs to track and document each procedure. Such response spaces include check-offs for additions of ingredients (with confirmed amounts and component lot numbers), measurements, adjustments, and process procedures.

Ingredient additions are also monitored by bar code weight verifications that do not allow the operator to proceed unless accuracy is confirmed. HyClone adheres to cGMP guidelines for proper initialing, dating, supervisor review, and sign-off for these documents.

Before any lots are produced, all raw ingredients are controlled and confirmed via HyClone’s bar code verification system.