Supplier Audits project quality plan

Pharmaceutical and healthcare companies may consider conducting predelivery checks on their suppliers to verify that Supplier Project/Quality Plans have been implemented. Computer systems should not be accepted at their user sites if outstanding and agreed issues from the Supplier Audit have not been resolved to the satisfaction of the pharmaceutical or healthcare company. 

For those chapters proposing typical procedures with model forms concerning responsibilities on site, supplier site visits, quality plans and records, engineering queries, incoming inspection and maintenance, nonconformities, audits, management reviews and construction completion and turnover, the forms concerned can be downloaded from the Wiley-Blackwell website www.blackwellpublishing.com/noble. They can serve as a basis for the reader to create his/her own forms adapted to the needs of a specific project. 

Supplier prequalification response Supplier audit report Project and quality plans Software quality assurance plan Commercial and purchasing specs. 

Because of such uncertainties, each supplier should be audited at the start of the project to establish whether a Quality Management System (QMS) exists that will support the validation of the equipment or process. Where none exists, an agreement must be reached with each supplier as to what quality measures will be used. This should be outlined by each company in their Quality Plan. In our case, we decided that all companies concerned should comply with the GAMP Guide, as this outlines validation documentation that is suitable for the U.S. Food and Drug Administration s (FDA) requirements and may also be used to support the European Union s CE mark accreditation (see Table 40.1). The device was to be released in both the American and European markets. 

At the completion of implementation, a Validation Report is required to summarize all of the validation activities. It should summarize the outcome of each step identified in the Validation Plan and review the progress of any outstanding actions from the IQ, OQ and PQ task reports. There may also be issues from the Supplier Audit or the review of compliance of the systems integrators against their own QMS that may need to be assessed. The report should then assign a validation status. It should also set a time for when a quality review of the system should be conducted. This is usually one year if the project is being implemented in phases, the report may defer assigning a review date until all of the subsequent phases have been completed. 

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