The change control program is the mainstay of maintaining a compliant state of the process or operation. It is used in every aspect of the process, from equipment changes through process parameter changes. Since the compliance program is ongoing, all modifications, regardless of how small, must be done under a formal change control program. The purpose of a change control program is to have a written record of any, and all, changes that occur to the equipment, process, or supporting documentation, including computer software and/or Programmable Logic Controller (PLC) code. An important outcome of a working change control program is that all documents related to the changed item(s) are updated and reapproved if necessary. These documents include the User Requirements (URS), Functional Requirements (FRS), Design Specifications (DS), Traceability Matrix (TM), Standard Operation Procedures (SOP), and other life cycle validation documents. As stated, change control is a key element of the production process. The FDA expects that all processes undergo “continuous improvement.” In order to do this, changes have to be made to the process. These changes can, and often do, include changes in equipment, operating conditions, or even the location of the equipment to improve product flow. The first question often asked is “When does change control start?” Change control starts when GMPs begin. The program should be put into place before the qualification starts. It becomes active upon completion of the commissioning of the equipment, since any change in the unit from that time will impact its GMP readiness. That is, at the very first entry into an equipment qualification protocol. Thus, change control does not apply to basic research operations. The researcher is free to use any chemicals, equipment, or procedural steps while they are searching for the most effective pharmaceutical agent. Once the Installation Qualification (IQ) protocol execution is started for a piece of equipment you need to make changes via the change control program. In order to make any change in a process after the equipment has been qualified and the process validated a change control form needs to be completed. The reason for this is simple; the equipment was designed in a specific manner to perform a specific function so any change or deviation from the “expected” needs to be documented. The above is not meant to exclude recording changes made during commissioning. While these changes or fixes are not usually under the change control program, any changes made during commissioning also need to be recorded. These changes will then be reflected in the qualification protocols (eg, IQ or Operational Qualification, OQ). By definition then, changes made during commissioning (getting the equipment ready for use) are not generally considered as part of the change control process. In fact, one usually keeps these changes separate so that time is not lost getting the equipment ready for use. Whether to keep commissioning under the change control program is a decision of the Quality Unit of the company. In addition to any changes made during commissioning or qualification, change control also applies during production. Anyone can make a request for a change to the equipment or process. For example, this could include equipment improvements, process improvements, or flow improvements. Prior to making any changes, either during qualification or during production, a change request form needs to be completed. In this form the change to be made is identified and the reason clearly defined. An example of a simple Change Control form can be seen in Appendix C. This then is forwarded to several departments for review and approvals as indicated:
The Role of Change Control
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