GMP

In my last post, I described change control process in general and I mentioned that in the regulated industries, manufactures are required to use a change control procedure. I am going to describe this change control procedure in this post.   A change control procedure is usually one of standard operating procedures (SOP's). It usually includes a change control form. Some companies also use change request forms for suggested changes. This procedure usually includes the following components:   Identification   The identification of the changed device, assembly, component, labeling, packaging, software, process, procedure, manufacturing material, and any other related item or document. The change control form has blank spaces for recording this data. Read more

Change control within quality management systems (QMS) and information technology (IT) systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. It reduces the possibility that unnecessary changes will be introduced to a system without analysis, introducing faults into the system or undoing changes made by other users of software.   The goals of a change control procedure include minimal disruption to services, reduction in back-out activities, and cost-effective utilization of resources involved in implementing a change.   Change control is used in a wide variety of products and systems. For Information Technology (IT), it is a major aspect of the broader discipline of change management. Typical examples from the computer and network environments are patches to software products, installation of new operating systems, upgrades to network routing tables, or changes to the electrical power systems supporting such infrastructure. Read more

In my last post, I described the GMP requirements for document control. In this post, I am going to describe the GMP requirements for information technology used in a GMP company.   For a drug to be produced in a GxP compliant manner, some specific information technology practices must be followed. Computer systems involved in the development, manufacture, and sale of regulated product must meet certain requirements. Read more

In the regulated environment, the document control is the cornerstone of the quality system. It is so important that if an external audit identifies deficiencies in the document control system, the entire organization can be shut down.   In my last post, I talked about the connection between ISO 9001 and document control. ISO 9001 is one example of the regulated environment. It is usually used in engineering types of companies. In food, drugs, medical devices, and cosmetics industries, GxP/GMP regulations are used. Today, I am going to talk about the connection between GxP/GMP and document control. Read more