Inventory processes, audit

An inventory of systems and knowledge, of which one is GMP-critical, must be maintained and available for inspections. An MHRA preinspection checklist has this as one of its opening topics. The availability or otherwise of this information is a clear indicator of whether management is in control of its computer systems validation. The use of an inventory need not be limited to inspection readiness it could also be used for determining supplier audits and periodic reviews, etc. Many pharmaceutical and healthcare companies use a spreadsheet or database to maintain this data. Where a site s inventory is managed between a number of such applications (perhaps one per laboratory, one for process control systems, one for IT systems), care must be taken that duplicate entries are avoided and, equally, that some systems are missed and not listed anywhere. It should be borne in mind that where spreadsheets and databases are used to manage an inventory, it should be validated just like any other GxP computer application. 

Experience has shown that when OSHA conducts a compliance audit of a plant, facility, and/or other workplace, the auditors routinely seek out and document any container containing hazardous materials. When they find one (and more), they usually write down the brand name of the product and later ask to see an MSDS for each product found. Again, based on personal experience, it is at this point in the audit process that the property owner or manager gets into trouble with OSHA compliance (if not already there). We have found that it is not unusual for the in-house facility compliance manager to forget the Hazard Communication Standard requirement for the facility to produce and maintain a current inventory of all chemical products within the workplace. 

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