Why was my test result out of specifications?

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You Can Trust the Result
We use an FDA compliant Outside of Specification (OOS) process to investigate all OOS test results before they are reported. Guidance for Industry: Investigating Out-Of-Specification (OOS) Test Results for Pharmaceutical Production-U.S Department of Health and Human Service Food and Drug Administration Center for Drug Evaluation and Research (CDER), October 2006 Pharmaceutical cGMPs and Pharmaceutical Quality Control Labs (7/93)-Guide to Inspections of Pharmaceutical Quality Control Laboratories are the resources used to guide our investigations and are cited throughout our OOS Department SOPs.  Please feel free to ask us for a copy!

Before we notify you of an OOS result, we perform an internal review of anything DYNALABS might have done to contribute to the OOS result. All OOS investigations include a Phase I and Phase II review before a customer is ever notified of an OOS result. The two-part review not only follows regulatory guidance but ensures an internal error has not been identified.

The initial review, performed by laboratory leads and SMEs, includes:

The secondary review, performed by OOS Investigation Analysts, includes:

Only after we have thoroughly reviewed the data, methods, equipment, storage conditions through initial and secondary review and have not identified an internal error, do we contact you with the OOS result.

You Can Find Out What Happened – Just Ask

We are glad to work with you to find out what caused the OOS result and determine how to prevent it in the future.

Our collaborative approach relies on your cooperation to review formulas, results history, batch records, equipment/training records and anything else that might have contributed to the failure.

We will use our expert knowledge of OOS investigations, sample preparation, and testing to help you:

In addition, DYNALABS offers consultant services that can aid in batch record review and revisions, process evaluations and audits that may aid manufacturing facilities in preventing OOS and compliance with guidance.

Still Have Questions? Come Visit Us
DYNALABS is pleased to host you for a Quality Systems audit. Please contact your Sales Representative, if you would like to visit our facility. We ask only that you give us at least 30 days of notice.

DYNALABS is dedicated to providing solutions, not just results, and we have the certifications and reputation to back it up: