Enterprise 21’s Process Manufacturing Software Functionality Enables Process Manufacturers to Establish Procedures and Controls Necessary to Meet GMP Compliance

First, there needs to be control in the ingredients being acquired for use in the manufacturing processes.  Suppliers need to be qualified and held to high standards.  Good ERP systems like Enterprise 21 enable companies’ purchasing organizations to establish criteria for the qualification of vendors and suppliers.  Once given vendors become approved, they can be enabled in Enterprise 21 as valid suppliers for the manufacturer to do business with while monitoring supplier performance over time.

As ingredients go through various processes, Enterprise 21 documents and time stamps each of these transactions and their associated operators for complete traceability of those parties involved at every step in the chain.  These processes include:

• Receiving,

• Movement to a quality control holding area,

• Quality control evaluation, approval, and release for use,

• Product putaway,

• Manufacturing picking and staging,

• Consumption in manufacturing, and

• Putaway of any excess inventory not consumed in manufacturing.

Before manufacturing occurs, authorized personnel can establish one or more manufacturing processes by which to produce a given product and the product’s associated formulation and recipe.  The identities of the personnel who establish the production routings and associated formulations are documented in the system, as are the identities of all personnel involved in the workflow process to review and approve these items prior to their release for production.

When a product is being produced, the manufacturing personnel involved in the processes associated with that production are recorded in Enterprise 21.  Also, electronic signatures can be used for supervisory personnel and management to sign off at key points during the manufacturing processes acknowledging the product has been made in accordance with documented procedures and associated safety standards.

As the product is produced, it too will undergo a series of quality assurance tests in order to gain approval for shipment to customers.  The individuals who perform the QA tests are documented in the system, as are the warehouse personnel who move and put away the finished goods inventory.  Finally, as sales orders are entered for given items, the personnel who pick, pack, and ship the finished goods to fulfill those customer orders are also documented in the system.

In addition to the documented controls of all individuals involved in the complete process from ingredients to customer shipments, all associated lots are recorded in Enterprise 21 to enable complete womb-to-tomb lot traceability.  Ingredient lots from suppliers flow into manufactured lots of produced products, which are ultimately shipped to customers.

Strong ERP systems like Enterprise 21 enable process manufacturers to meet cGMP guidelines through the complete product and process flow throughout the manufacturing enterprise.