Friday, April 3, 2009

cgmp requirement of maintenance department

The Maintenance Department should have the layout plan of every system for example,
1. Water Supply System (Chillers, Deionizers, Hot Water System)
2. Water Waste System (All Factory)
3. Air Supply / Handling System
4. Electrical supply System (Machinery)
5. Lighting System
Maintenance of Machinery:
1. The maintenance department have schedule for maintenance of machinery, implementation.
2. List of no of lights.
3. List of no of fans.
4. List of no of AC’s, Split units, Window Units (AC’s).
5. List of tools.
6. Training of use of tools.
7. List of spare parts with names, with part no, manufacture name, or if it is imported the name and address of the manufacturer, telephone no’s, in case of emergency.
8. The maintenance department should have the SOP’s for opening a machinery with the use of suitable tools and re assembling with summitry.
9. Safety precautions for handling heavy machinery and tools.
10. Safety precautions and safety tools while working on electrical lines
11. The maintenance department should have separate workshop for repair and maintenance work near the building.
Self Inspection:
Self inspections should be conducted in order to monitor the implementation and compliance with GMP and to propose necessary corrective measures.
1. Personnel matters, premises, equipment, documentation, production, quality control, distributional of medicinal products, arrangements for dealing with complaints and recalls, and self inspection, should be examined at intervals following a pre arranged program in order to verify their conformity with the principles of Quality Assurance.
2. Self inspection should be conducted in an independent and detailed way by designated competent person(s) from the company. Independent audits by external experts may also be useful.
3. All self inspections should be recorded. Reports should contain all the observations made during the inspections and, where applicable, proposals for corrective measures. Statements on the actions subsequently taken should also be recorded.

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