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procedures in place, product producers run the risk of equipment failures causing key pieces of machinery to be withdrawn from use.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 is in an environment where; 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 wears-out or breaks, if a replacement isn’t nearby, the company may be stuck with a 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 is 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 pre-empt the envisaged breakdowns.
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 Change Control System must maintain 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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This combination protocol has been produced in response to several
hundred reader suggestions we received in our ‘Suggestions Section’. It
has been carefully designed to make it the preferred choice for Process
and Laboratory stand alone equipment. It is interactive, easy to use and
suitable for all mixes of equipment with and without software.
The IQ section establishes documented verification that key aspects of the equipment adhere to approved design intentions and that the recommendations of the manufacturer have been suitably considered. The OQ section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documentary evidence to demonstrate this. The PQ section gives documented verification that the equipment performance in its normal operating environment is consistently exactly as specified in the URS.