System and Method for Validation of Pharmaceutical Composition Formulations

• US 20140350945A1
• Filed: 05/22/2013
• Published: 11/27/2014
• Est. Priority Date: 05/22/2013
• Status: Abandoned Application

• Current Assignee: Professional Compounding Centers of America Incorporated
• Original Assignee: Professional Compounding Centers of America Incorporated
• Inventors: Klomp, Paul P.
• Application Number:
  US13/900,332
• Publication Number:
  US 20140350945A1
• Time in Patent Office: Days
• US Class Current: 705/2
• CPC Class Codes: G06Q 10/087 Inventory or stock management, e.g. order filling, procurement or balancing against orders
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 70/40 relating to drugs, e.g. their side effects or intended usage

Abstract

The present disclosure relates to a method for validating formulations in pharmaceutical compositions. The method may include entering inventory into the system, formulating the batch, storing batch compounding data, manufacturing the batch, assigning and printing a barcode on the pharmaceutical compositions, scanning the barcode, checking if correct chemicals are used, and correcting the pharmaceutical compositions formulation if required. The present method may prevent a batch to be produced until the batch has been corrected in cases where incorrect chemicals are used in pharmaceutical compositions, and may additionally improve accuracy and efficiency of quality control because data, such as lot numbers, does not have to be hand-typed when barcodes are scanned.

Claims

1. A method for validating a formulation in a pharmaceutical composition, the method comprising:

providing, to a non-transitory computer readable storage medium having encoded thereon computer executable instructions for providing at least one inventory control system, at least one batch protocol comprising at least one compound formula;

associating a unique identifier for labeling manufactured product with the at least one batch protocol;

analyzing a composition of one of the manufactured product; and

comparing the composition to the at least one compound formula;

wherein the inventory control system provides an indication of the comparison between the composition of one of the manufactured product and the at least one compound formula.

2. The method of claim 1, wherein the at least one batch protocol is changed by the indication of the comparison between the composition of one of the manufactured product to the at least one compound formula.

3. The method of claim 2, wherein a change of the at least one batch protocol comprises one selected from the group consisting of change in compound formula, compound quantity, compound potency, and combinations thereof.

4. The method of claim 1, wherein the at least one inventory control system is changed by the indication of the comparison between the composition of one of the manufactured product to the at least one compound formula.

5. The method of claim 1, wherein the comparison between the composition of one of the manufactured product and the at least one compound formula is between at least one selected from the group consisting of chemical composition, purity, potency, waters of hydration, loss of drying, and combinations thereof.

6. The method of claim 1, wherein the unique identifier comprises at least one lot number.

7. The method of claim 1, wherein the at least one compound formula comprises at least one individual ingredient attribute selected from the group comprising molar weight, name, color, interaction profile, stability profile, and combinations thereof.

8. The method of claim 1, wherein the unique identifier is a barcode.

9. The method of claim 1, wherein the unique identifier is selected from the group consisting of EAN/UPC, GS1 Data Matrix, GS1 DataBar, GS1-128, ITF-14, GS1 QR Code, and combinations thereof.

10. The method of claim 1, wherein the unique identifier is read by one selected from the group consisting of a fixed location scanner, hand-held scanner, a wearable scanner, a pen-type scanner, a CCD reader, a laser scanner, a camera-based reader, and combinations thereof.