Planned Preventative Plant Maintenance of the Validated State.
Without Planned Preventative Plant 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procedures in place, product producers run the risk of equipment failures causing key pieces of machinery to be withdrawn from use.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,Planned Preventative Plant 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.
PLANNED PREVENTATIVE PLANT MAINTENANCE
Risk Mitigation in Validation template (Issue 11) $125.00 The Risk and Part 11 Validation Risk Assessment(VRA) protocol is becoming the most important document in the validation online train. The VRA reassures the regulators that you have looked at specific equipment functionality and considered the appropriate level of validation that is required. You have also considered various aspects of its use and the implications of any malfunctions. From the results of this exercise the scope of all validation activity can and must be justified. This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your Risk Mitigation in Validation template.
This VRA now includes the assessment table for categorizing and documenting the new 21 CFR Part 11 guidance ruling on what predicate data must be stored in a Part compliant system, along with the new broadsheet to establish your new database of part 11 records. (now mandatory).
This Pharmaceutical Validation 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 and associated standard operating procedure TEMPLATE. The associated medical device validation Master Plan template is interactive, easy to use and suitable for all mixes of equipment with and without software. Where temperature mapping is required it will included in this section. This of course may well be a Risk Mitigation in Validation risk Assessment template. As per 21 CFR Part 11.
The Installation Qualification Template or IQ section establishes documented verification that all medical device validation template online executables are catered for and that key aspects of the equipment Qualification adhere to approved design Qualification template and the recommendations of the manufacturer have been suitably considered. The Operational Qualification Template section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documented process validation A executables to demonstrate this. The PQ section develops documented evidence that all the requirements specified in your corporate validation 4U manual have been verified as operating consistently and exactly as specified in the medical device validation template; The User Requirements Specification template
The Standard Operating Procedure template (SOP) used to generate this installation Qualification template (IQ), takes you through the process line by line, chapter by chapter. It really is unique to find a SOP document so easy to use, all the work is done for you. All the documents are detailed, all the drawings listed and all the checks and tests detailed. The final product is a professional and comprehensive Installation Qualification template. One that you can produce in less than 60 minutes. Yes, think about it, we all know how long producing IQ documents has taken in the past, whether for current Good Manufacturing Practice use medical device use or a simple installation qualification template.
You will find this validation online intuitive Operational Qualification template (OQ) delightfully simple and straightforward to use, as it takes you through the process of customization of your Operational Qualification Protocol template. Following the attached SOP will quickly and smoothly convert your template into an equipment specific 21 CFR Part 11 compliant Installation Qualification Template. The OQ template comes complete with all the standard test scripts, more specialist test scripts can be found listed below. These can easily be pasted into the standard OQ, allowing you to quickly build your own fully detailed and referenced company bespoke Operational Qualification Protocol, along with the installation qualification template.
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.