Foundational Blocks

10 things you can do to Prevent Adulteration

Part 1

1. Properly hire, onboard, and train all personnel who will be working in your company and provide them with the tools they need for their area of responsibility.
2. Establish your organization’s Current Good Manufacturing Practices that pertain to your product(s). This should include everything from receiving raw materials to the shipment of finished products.
3. Document your organization’s requirements in a concise but detailed written plan.
4. Prepare detailed Standard Operating Procedures (SOP’s)
5. Outline the company’s process to include;
   1. Product Specifications
   2. In Process Checks and Control and Critical Control Points (CP’s and CCP’s)
   3. Documentation and Recordkeeping Requirements (include Frequency of Checks)
6. Establish escalation and communication procedures for any component that is out of range or there is an issue identified.
7. Clearly articulate the quarantine and hold procedures for sub-standard products.
8. Determine the Corrective Action process the organization will follow after determining a failure has occurred.
9. Outline procedures and processes for the company’s rules if an employee is ill or becomes ill while at work.
10. Inform all employees of the process of who to contact if they notice an issue or have a concern.