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.
- What are the techniques used to spot Out of Trend?
- How is the Pharmaceutical industry benefitting from OOT?
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?
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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,
How to handle Out of Trend results?
Out-of-trend results are categorized into three aspects,
- 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?
Simple and Easy to use QMS software
Quality-centric companies rely on CQ QMS
Frequently Asked Questions
What are the challenges of OOT?
What are the methods used to find 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?
- 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.