January 26, 2016

Device Master Record

 

 Good Manufacturing Practices require that you have a Device Master Record for each unique formulation and each unique batch size. This ensures that all proper ingredients are added, that each process step is completed according to an established procedure and that essential points in the process are controlled.

InstantGMP provides electronic device master records that contain all the information required by GMPs:

  • A complete list of components to be used
  • An accurate statement of the weight or measure of each component to be used
  • The identity and weight or measure of each device
  • A statement of theoretical yield at each step of the manufacturing process where control is needed to ensure the quality of the dietary supplement
  • The expected yield when manufacturing of the device has been completed
  • Written instructions, including specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the device
  • Procedures for sampling
  • Written instructions for manual operations, for example, one person to add and another person to verify the addition of the components
  • DMRs can be hidden, printed, edited, viewed, and searched
  • Approvers are assigned the responsibility of approving or rejecting an DMR. They must sign in order for it to be issued and for the ability to create Batch Records
  • After one approver has signed, the DMR is locked
  • An DMR can be unlocked to make edits. The first approver must sign the DMR again to approve
  • Each DMR can have multiple versions
  • Attachments are read-only once uploaded

Master Production Records With Version Control:

  • A new version of an DMR can be created
  • A copy can be generated, but one or more of the fields project title, product name, client, author, formulation ID and Theoretical Batch yield
  • DMRs have the ability to scale up or down a recipe and auto-populate the updated inventory
  • These records cannot be deleted but can be hidden