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Out of specification investigation is a process that pharma companies use when a product does not meet the specifications set by the manufacturer. This could be because the drug was manufactured incorrectly or there was an error in the labeling. Out-of-specification investigations can be costly to the company and result in lost sales and litigation.
Out-of-specification investigations typically begin with a customer or patient complaint. If the company can’t find a reason to go off the drug’s specification, they can open an investigation to find out what happened. During an investigation, technicians will test the medication to see if it meets specifications and also look for any clues as to what may be causing the problem. Sometimes, it is possible to determine why the drug is off specification and fix the problem. Other times production of drugs has to be stopped and new batches made.
Out-of-specification investigations can be costly for companies, especially if they have to restart production of large quantities of drugs. They can lead to lost sales and lawsuits.
