Facility Utility Maintenance of the Validated State.
Without facility utility maintenance procedures in place, product producers run the risk of equipment failures causing key pieces of machinery to be withdrawn from use. This one piece of equipment, can in certain cases result in the closure of a complete production line. What’s worse, once a part or component burns out or breaks, if a replacement isn’t nearby, the company may be stuck with this closed production line until a new part can be delivered from the equipment manufacturer.
If companies don’t put the proper servicing techniques in place, their equipment is going to fail, or become inconsistent in it's operation. In this state, facility utility maintenance and repair costs will be high, since it will mainly consist of recovering from catastrophic break downs. A good service management system helps a company’s engineering department plan and schedule their work. It also helps them manage spare parts, track who worked on a piece of equipment, and who signed off on it.”
Clearly, being able to track cleaning activities is important. There is now a lot more attention being paid to the whole level of servicing in and around a pharmaceutical manufacturing facility. Minor things like tracking filter changes and inspections on compressors to make sure they are not leaking oil. To the use of predictive analysis tools, used to anticipate possible equipment breakdowns, thus allowing engineering departments to put in place proactive action, that will inhibit the envisaged breakdown causes.
A change control system (CCS) requires a controlled approach towards maintenance, management and operation in a regulatory control manufacturing facility. The system must manage the entire change control process including initiating, reviewing, approving, distributing and storing change history. In addition, the system should also help capture relevant information about the objective, nature and scope of change. The defined scope of the CCS program must also cover a broad set of possibilities including changes to facilities, utilities, equipment and computer systems, manufacturing instructions, SOPs, test methods and specifications.
A CCS maintains a history of the lifecycle of all change requests - requester name; reviewer(s) name, date reviewed, approval date and name, implementation date etc. Such information is used by FDA during audits to ensure change control procedures are working well. Hence the major benefit of a change control implementation is that it facilitates a regulatory environment while supporting change for continuous improvement. As a result, change control ensures that the company continues to comply with cGXP.
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