The Compliance Process Overview
This diagram shows a typical process flow in a GMP manufacturing operation. The process begins with a manufacturer identifying the product that will be manufactured and what materials, components, and other supplies are required to start production. A manufacturer must then select and qualify their vendors prior to receiving materials that will be used or made in the facility. InstantGMP™ has SOPs available that can guide the qualification of those vendors.
Once materials are ordered and delivered by a qualified vendor, they can be received into inventory. These materials, components, supplies, and other ingredients can be entered into the system. InstantGMP manages the receiving process and assigns unique numbers for each material, material receipts, and material lots; thus setting up traceability. The FDA has requirements that encompass the purchasing, receiving, and testing of incoming materials; therefore, InstantGMP features multiple functions to keep them under control and organized. Additionally, a quality unit must sign off that the materials that were ordered are the ones that they have received. With our system, we manage the material types and statuses for you.
Before these materials, components, and others can be used in production, they all must have specifications. Every material that will be used in a product, as well as each finished product, must have specifications. InstantGMP will manage these specifications and automatically track version numbers in an effort to streamline the quality process.
When it comes time to manufacture a product, a master batch record needs to be written to describe how the product will be produced. Then a copy of the master is used to make a uniquely numbered batch production record. InstantGMP does all this electronically. Storage and distribution of finished products are covered by the FDA. InstantGMP covers these requirements in its inventory management feature.