January 25, 2016

cGMP Compliance Process Overview


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 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 come 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 FDA. InstantGMP™ covers these requirements in its inventory management feature.