Repair program in the pharmaceutical industry ( Maintanance Program in pharmaceutical industries) :The purpose of the maintenance and repair program is to provide a scientific and practical plan for maintaining the operation of the device./ System and Utility Even Facility to be developed in the design areas for production and from Prevent any disturbance or non-compliance with the established regulations that affect the quality of the product.
Repair programs in the pharmaceutical industry are divided into two general categories in the production plan :
1- Preventive repairs or PM- Preventive Maintanance .
2- My section reconstruction oh my necessity, BM- Breakdown Maintanance .
It is mandatory for both devices, equipment and systems to perform repairs on the drug plant.
In preventive repairs, the purpose of planning for regular repairs and forecasting repairs of devices and parts
And prevent damage and consequently improve it before the device or system is worn out. .
This will reduce the downtime of devices and systems with codified programming.
Each piece of the device predicts its repairs before the problem occurs according to the manufacturers advice,
Historical background ( Available device ) Work is done .
System of keeping records and notes in repairs and maintenance and replacing parts and ordering them
One of the most important requirements in cGMP.
Whenever for any reason, an accident or problem occurs in the device, equipment, system that is in repair,
Prophylaxis is unpredictable or unpredictable, occur cross-sectional or BM repairs. .
In accordance with cGMP regulations for the evaluation of devices and systems and Validation They have a plan Comprehensive and comprehensive in the field of repairs and maintenance, especially preventive repairs, is very vital. .Because all operations of evaluation and validation, even their calibration, are highly dependent on The program is written for maintenance and can be predicted .
Repair programs are basically supportive and essential (Supporting program) It is validation .
As soon as Facility starts, startups are prepared in parallel with that repair program To survive the validity of the Facility / Device, system (system) And process and for sure From following and complying with the principles of cGMP Appliance inspection and cleaning program and policies/ System and Facility must be provided .
Required documents :
Documents required in this section include: :
1- Log Use of Maintence and Calibration یا LUMAC
2- Work order (Work-order) For PM and calibration
3- PM planning and scheduling
4- Device file / System and Facility
5- Qualitative identity card and quality number of the device
6- Prepare a regular schedule of spare parts ( Spare parts) And its replacement program
7- Training of repair personnel in production
8- Reconfirmation program in accordance with the repairs performed ( According to the re-validation program )
Andishegaran Comprehensive Iranian Industry Company
With specialized and experienced personnel and experienced staff in the field of installation,Launching and repairing service devices and equipment Provides the following :
Planning, preventive, cross-sectional and complete repairs in accordance with cGMP and quality systems .
Product maintenance and repairs (Productive Maintenance)
Inclusive productive maintenance and repair system (Total Productive Maintenance) .
Preventive maintenance and repairs (Preventive Maintenance)
Prophylactic maintenance and repairs (Predictive Maintenance)