Managing Formula Revisions Using Overage and Degradation Factors

Overage and degradation factors are typically setup in the pharmaceutical industry to specify additional raw materials that must be put into a batch to compensate for degradation during manufacture or a product's shelf life. For example, consider a label for a multivitamin that indicates the vitamin contains 100% of the recommended daily allowance (% Daily Value) of B12. The multivitamins contain a shelf life of 18 months. Over time the multivitamin may breakdown so that 12 months after the date of manufacture the % of B12 is more like 95% of the % Daily Value. To offset this, the manufacturer would add a 10% overage factor on the BOM line to indicate that they add 10% more than the quantity specified on the BOM line for B12 to ensure the % of B12 is maintained throughout the multivitamin's shelf life.

The FDA recommends that any overage or degradation factor be justified considering the safety and efficacy of the product. They suggest providing the following on the batch ticket when used:

  1. Amount of overage applied to the formulation
  2. Reason for the overage (e.g. to compensate for expected and documented manufacturing losses)
  3. Justification for the amount of overage

In most cases, pharmaceutical companies will use overage factors to account for the breakdown or degradation of ingredients. DEACOM provides the ability to input the overage quantity and select the calculation method used on each line of the bill of materials.

Configuration

Using these factors requires the same configuration as defined on the Adding and Modifying BOM Revisions page.

Process

Setting the default factor calculation methods

  1. Navigate to Inventory > Options > Inventory tab.
  2. Make a selection in the "BOM Line Calc" field:
    1. "Degradation" means the number entered degrades by percentage amount given and the original amount is left. For example, 40 mg with 10% of overage should yield 44.444 mg (44.444 * 90%) = 40. i.e. put in more so that when what we put in degrades by 10% we end up with our original amount
    2. "Overage" is used if a percentage more than the original amount is wanted. For example, 40 mg with 10% overage should yield 44.000 mg. i.e. only want 10% more than the original amount

Setting factors for specific Parts

  1. Navigate to Inventory > Bills Of Material > select a Part > click "Modify".
  2. Select the desired Part from the Bill of Materials and click "Modify".
  3. On the General tab, make a selection in the "Calculation Type" field and enter a value as a percent in the "Calculation Factor" field, based on the selection chosen in the previous field. Refer to the example in Steps 2.1 and 2.2 above if needed.
  4. Click "Save" and "Exit" to commit the changes and close the form.