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Out of Trend - OOT

Out of Trend (OOT)


What is Out of Trend (OOT)?

Out of trend is defined as a result of a sequence of the analytical results which conform to the specifications but not in the expected trend with respect to the initial or expected result. OOT reveals that there may be a problem with the analysis or the production process. The main purpose of OOT is to lay down a procedure for managing out-of-trend results in active raw material, finished product, stability study, environmental monitoring & water trend in pharmaceutical industries.

ComplianceQuest’s Lab Investigation Solution can provide you with a systematic, efficient, and compliant approach to laboratory investigations to check past activities and the history of lab investigations done. CQ’s lab investigation solution is simple for users to get to the assignable or root cause of every out-of-trend (OOT) test result and then act on it with agility with the help of comprehensive documentation and simplified collaboration. Thus, you can minimize rework and refer to past work quickly and efficiently.

Handling Out of Trend (OOT) is of utmost importance to Pharma and Biotech sectors. Pharma and Biotech companies should perform stability tests at regular intervals to find the status of the samples of raw materials, in-process materials, bulk products, and finished products. OOT results are time-dependent or stability results that fall outside a prediction interval or fail a statistical process control criterion during a stability study.

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The OOT results are to be detected by the systematic and experimental statistical method. To detect OOT results, it is crucial to ensure that the result obtained is correct. The guideline concerning the prior approval of stability studies is recommended by the ICH Q1A guideline, which specifies how to carry out the stability studies, and evaluation of stability data will be performed in accordance with ICH Q1E. You can set the retention time for arithmetic assistance. The post-approval stability study is conducted by using the same guidelines only once a year.

Several approaches are presented below to detect OOT instability results.

  • Regression control chart method: According to the Hewhart regression control chart the criterion
    of the true regression line and the residual difference is known to estimate a regression control chart from data within or between batches.
  • Regression control chart method for dissimilar ANCOVA models: In this approach data regression control chart criterion gets less unpredictable by using the earlier batches. The advantage of this approach is that slopes are equated so that they can be calculated although entire batches behave similarly.
  • Timepoint method: This method is supposed to decide whether a result is inside the assumption on the basis of knowledge from other batches analyze at a similar stable time point.
  • Multivariate distances: This method is susceptible to the estimation of OOT time where each time point of analysis will be included and removed to assess its impact on the model.


For the Pharmaceutical Industry, the microbiological, chemical, instrumental, and physical analysis of the raw materials and finished goods samples generates a large amount of informative data from the Quality Control Labs. Pharmaceutical companies generally use QC Sample OOT (Out of Trend) to ensure that the products meet the laid down specifications complying with FDA 21 CFR Part 11, EU Annex 11, cGMP, GMP, and other international and national manufacturing standards. A case of Out of Trend must be investigated when sample results differ or deviate from the sample’s historical results though they may be within specifications.

A simplified system can provide access to information, issue traceability, and accelerated investigation with a large number of samples. The FDA (Food and Drug Administration) underlines the importance of plant audits, warning letters, and investigations for pharmaceutical and biotech companies to use Sample OOT Automation and Trending Software to enhance the investigation process and facilitate better communication about the problems between different departments.


What are the OOT procedures?

Out of trend results are decided based totally on the data of previous batches or preceding analytical information observed at some stage in the analysis. At the same time while performing the analysis, if any out of trend facts are located then the analyst has to tell the executive quality controls to conduct the initial research together with the analyst. Executive quality control must keep the sample and trendy training used during the evaluation until the research is completed. Make sure that the necessary entries should be there in the OOT log by assigning the OOT number.
During the investigation, if the cause of the OOT result is identified as a laboratory error then executive QC should carry out the repeat analysis with a fresh sample and fresh standard preparation if required. And, if the purpose of the oot result isn’t diagnosed as a laboratory error, then the head of the QC will suggest reanalysis to confirm the oot outcomes. The analyst must hold the record of the re-evaluation effects in the worksheet.
If the cause of the re-analysis consequences isn’t recognized then the effects received in the course of the initial evaluation need to be suggested. In the case of raw material, the head quality controls ought to overview the OOT outcomes and forward them to QA and prevent the reoccurrence of such incidents. In the case of finished products, the head QC should review the OOT results and forward them to QA and the production team for investigation to take a final decision.
Within the case of stability studies, OOT investigations are completed and evaluation has to be executed if required the usage of the samples of the previous balance studies. Based on the investigation report, the head QC takes the final decision.

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What are the different types of OOT errors?

OOT errors arise specifically because of the spilling of sample solution or incomplete pattern transfer. So, an analyst should document what had happened along with,

Evaluation ought to no longer be finished for the only purpose of seeing what end result may be acquired when an apparent error is known.
After discovering the OOT error, the analyst concerned shall take necessary steps, and the corrected result sample shall be released once appropriate corrective and preventive action and investigation are closed.
If the OOT result is due to the analytical error, then a repeat analysis shall be performed after taking suitable corrective actions.

How to handle Out of Trend results?

Out-of-trend results are categorized into three aspects,

Analytical alert: When a single result is aberrant but within specification limits, like out-of-trend assay value.
Stage 2
Process control alert: A succession of stable information factors or successive batches of finished merchandise suggests a strange sample.
Stage 3
Compliance alert: Compliance alert refers to when a selected stability study or release result does not meet specification limits all through the expiration length or with the regulatory specification of the equal product.
Out of Trend results
The QU should involve all capabilities liable for the production, including engineering, manufacturing, method improvement, and maintenance, earlier than leading the investigations. After identifying potential problems, they should be investigated properly to proactively prevent the same known issues from occurring. All statistics and files related to the manufacturing system need an in-depth, properly-documented evaluation to decide the possible purpose of the OOT result. The evaluation document needs to encompass:
  • A clearly defined reason for the investigation
  • A brief on the numerous production factors that could be answerable for the trouble.
  • The findings of the documentation review to identify if this is a recurring problem and assign the actual or probable cause.
  • Recording of the corrective measures

Who will be benefited from OOT?

Pharma and Biotech Companies get benefited from OOT as the overall lab investigation process can
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Reduce the time needed for investigations with enhanced system efficiency
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Discover trends for root cause analysis with the aid of monitoring the consequences of all of your investigations
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Reduce cycle time and save cost
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Make sure that your investigations adhere to regulatory requirements
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Document all steps, assessments, results, checklists, and findings

Simple and Easy to use QMS software

We chose to implement CQ’s Non-Conformance Management, CAPA Management, Document Management and Related Training, Audit and Supplier Management. Works as shown. It is easy to configure, manage and use. We chose ComplianceQuest to address our ISO 9000 compliance, other regulatory requirements and Continuous Improvement needs. Our criteria was that the software should be cloud based, address the ISO 9000 requirements well, easy to implement, accessible from anywhere and also from any device. CQ has been by-far the easiest and Customer service is by far the best.
Venkatragavan Jayabalan,
Appasamy Associates


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Frequently Asked Questions

What are the challenges of OOT?
OOT and OOS investigations are an important aspect of clinical development and testing, and it requires visibility into the documentation, follow-up action, investigation processes, and regulatory submissions. It additionally ensures that the product is not driven into the marketplace before the investigations are finished and corrective action is taken.
Since collaboration is the key, you should keep everyone informed, assign tasks and follow up to ensure that the required action has been taken. Laboratory investigations also can be time-consuming and absence the consistency or completeness needed to meet regulatory necessities.
The process of finding Out of Specification (OOS) and Out of Trend (OOT) through manual procedures is difficult as it involves a lot of paperwork. Initially, a QA will conduct the test and manually note it down. Once the reviewer receives the test result, he goes through all the steps again to suggest the next step. An investigation might be raised to find the reason for OOS or OOT. After receiving the final sample for investigation purposes, the analyst must also repeat all the testing steps and note down everything manually. Thus, a lot of scope for transcriptional errors and compliance issues occur.
In many companies, the production group sends a batch of raw materials or completed items for production or sale even earlier than finishing the research for an OOS or OOT. This can lead to serious issues when an auditor requests all OOS or OOT investigation documents. The auditor can question the reason for taking the next step without complying with the FDA regulations.
What are the methods used to find OOT?
The subsequent 3 methods are used to locate OOT:
  • Estimating the average of past readings
  • Following 3 Sigma
  • Tracking the high and low range of the preceding outcomes
What are the features of the CQ Lab Investigation Solution?
The key features of the CQ Lab Investigation Solution involve,
  • Phased Investigation: Phased Investigation defines the escalation from phase 1 to phase 2 or closes the investigation for QA and Lab supervisors.
  • Unified: You can launch NCs and actions directly from the investigation record and link records together with the help of Lab Investigation Solution.
  • Automated Notifications and Alerts: Automated Notifications and Alerts can help to send action requests to people involved in the investigation by sending notifications to them.
  • Regulatable Queues: Regulatable Queues can help to approve matrix queues by configuring the workflow to fit your needs and processes.
  • Integrated Printouts: Integrated Printouts refers to assigning file structure and personalizing printouts of investigations whenever needed.
  • Dashboards and Reports: Any dashboard or report that can help to identify trends and keep track of lab investigations.
  • Pre-designed Checklists: Pre-designed and customizable checklists can help to guide the investigation ensuring consistency and thoroughness.
  • Customer alert Evaluation: This automatically notifies the quality team if a customer alert is needed at the end of the investigation.
  • Customer Notification: After phase 1 and 2 lab investigation, quality teams can notify customers if needed.
  • Attachments: This includes attaching images or tables in the lab investigation descriptions, test plans and conclusions.

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