Change Control Program

The focus then shifts to a discussion of transdermal process validation. This particular discussion will share a method for completing this critical step. Although the method for completing validation for transdermals is important, there are two other items that must not be forgotten validation documentation and the establishment of a solid change control program. Later sections of this chapter will discuss each area in adequate detail. As the chapter draws to a... 

While CGMPs do not specify a change control program per se, there are several requirements currently included in the regulations that would lead one to develop a written control system. 

A comprehensive change control program must be in place to chronicle changes made to methods and protocols. 

There are several sections of the CFR that address the control of documents. Obviously, documentation supporting each phase of the life cycle of the master production record should be maintained under change control. A change control program at these early stages will verify that appropriate departments are part of the review process and that changes are not made without sufficient data support. 

Change Control will be written to ensure that systems and processes remain in a state of validation. The procedure outlines steps to follow when a change is proposed. The change control program ensures that proposed changes are reviewed and approved by appropriate departmental representatives prior to initiating changes. The review also defines the required tests and documentation to be performed to verify that the system, equipment, and process remain in a validated state. 

The change-control program should include procedures to ... 

The change-control program should provide for a classification scheme to evaluate changes in raw materials, manufacturing sites,... 

Change" as used here refers to a new or fundamentally different system or procedure. Replacement in kind is excluded. All true modifications must be well documented. No modifications should be permitted without prior authorization and follow-up documentation. Extensive or higher levels of change should require higher levels of authorization. A carefully planned and executed Change Control Program must be instituted to prevent the hazards that often arise from quick responses. 

---