Case Study

Pre-Audit Services Protect Top Drug Manufacturer

Source: Mettler-Toledo Product Inspection

In an environment of increasing safety regulations and compliance audits, a large midwest pharmaceutical product manufacturer turned to Mettler-Toledo Safeline for a systematized annual pre-audit program for their 70-plus metal detectors and x-ray inspection systems. Their annual pre-audit contract, which was recently renewed for a third straight year, ensures that all their Safeline product inspection equipment will pass strenuous yearly audits. The value to them is clear – if a metal detector x-ray inspection system does pass the audit, it must be pulled from the line and the line must be shut down until it is either recalibrated or replaced.

Under their customized pre-audit contract, two Mettler-Toledo Safeline service technicians visit their large manufacturing plant four times per year, spending two full days during each visit verifying and documenting that 15-20 machines are in compliance with regulatory requirements. The four times per year schedule insures that 70-plus machines have been pre-audited at least once in the previous 12 months no matter when their actual compliance audit occurs. Each machine is rigorously tested to the required detection sensitivity and a thorough analysis of the machine's performance and condition occurs. If there is anything that is not functioning to peak performance, it is remedied before the technician leaves the facility.

The Company is very strict with their record keeping, and has created their own document to mirror the Performance Verification Certificate that is completed by the Mettler-Toledo Safeline technicians. With the documented assurance that all their product inspection equipment is operating at peak performance, the manufacturer can be confident that the equipment will pass an audit every time. Furthermore, their large retailer customers can also be confident that they are receiving products free from physical contaminants.

SOURCE: Mettler-Toledo Product Inspection

Mettler-Toledo Product Inspection