Records contract review

The standard requires the supplier to investigate and confirm the manufacturing feasibility of proposed products in contract review and to record the results of the review. 

The standard requires records of contract reviews to be maintained. 

Having determined that the item is in stock and informed the customer of the price, the supplier presents the lamp together with an invoice to the customer for payment. (The invoice is the record of the contract review.)... 

Establish who will hold the records of contract reviews, where they will be filed, and who will have access to them. 

In what documents do you record the results of contract reviews ... 

Premium freight was addressed briefly in Part 2 Chapter 3 under Contract review, as it is at the contract negotiation stage that the criteria will be established as to what is premium freight. If you fail to make delivery by the planned means (the means agreed in the contract) you may have no alternative but to choose a faster way of getting the shipment to its intended destination. This may result in additional cost. It is this cost that the customer wishes you to monitor and record. 

Management review records (clause 4.1.3) Process verification records (clause 4.2.4.9.4) Contract review records (clause 4.3.4)... 

Quality Management system priorities to consider are management responsibility, quality system principles, auditing, contract review, design control, corrective action, document control, quality records, training, product safety and liability, and statistical techniques, because these are critical aspects of the Quality Management system where Xmple Inc. already has some systems in place. 

Contract Review Note samples/files reviewed, records of discussions with customers ... 

If the answer to any of these questions is no, then the actions and responsibilities to be taken to resolve the deficiencies should be recorded and verified as complete. The contract should not start nntil any deficiencies are nnderstood and corrected. If a checklist is nsed, it shonld be annotated with answers to the qnestions and signed as complete by the contract reviewer (who may well be the qnality manager) and contract manager (who may well be the project manager). In this simple... 

The PI must be knowledgeable about the multiple processes needed to manage a clinical study, including the medical records system, investigational drug pharmacy, clinical laboratory, other clinical departments necessary to support the project, the institutional review and approval processes, budget and financial management, and contract initiation. 

There should be a quality unit independent of production that has the responsibility and authority to approve or reject all components, in-process materials, packaging materials, and finished excipients. The quality unit should have the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The quality unit should be responsible for approving or rejecting excipients manufactured, processed, packaged, or held under contract by another company. The quality unit can delegate these responsibilities if proper controls such as periodic audits and documentation of training are in place. 

FDA can audit the records of the study sponsor, as well as contract research organizations (CROs), to review standard operating procedures and all of the documents related to a particular clinical study, including electronic databases. Since 1981, nearly 200 such inspections have occurred. Departures from regulations requiring voluntary corrective... 

The standard makes it clear that a contract company s safety record is to be reviewed before they are hired and that safety record should be evaluated as part of the overall contractor selection process. Generally, the contractor s OSHA 300 logs will be used for this evaluation. 

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