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Auditing
Date: 2003-08-21 00:00:00.0
Contact: admin@globalregulatory.com
 
1 - Audit all contract laboratories that perform testing for your company. You are responsible for all of the work that your contract laboratories perform for you. It is very important to audit labs that are listed in product submissions to the FDA as the FDA may inspect those labs in the process of approving your product. If you are not confident in your auditing skills, ContractLaboratory.com provides 3rd party laboratory audit services. Contact us at admin@ContractLaboratory.com for more information.

2 - When auditing a lab, request all copies of state, local, federal agency inspection reports. Find out what types of observations that have been made about the lab, and follow up on their corrective actions.

3 - Obtain copies of the procedures that will be used by the contract lab to test your samples, and make sure that they are adequate. You may provide your procedures to the contract lab for their use to make sure they are testing the same way your company tests your samples.

4 - Review the out of specification handling procedures that are in place at the contract laboratory and make sure that they notify you immediately when there is an OOS incident with one of your samples.

5 - Review the contract lab's sample receiving, labeling and tracking procedures to ensure that they have control over where your samples will be at all times while in their facility. Discuss sample disposal or sample return before sending samples to the lab.

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For further information please contact admin@globalregulatory.com or visit


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