Difference Between Out of Specification and Out of Trend : Pharmaguideline

Online GMP Courses with Certificate

ENROLL

Difference Between Out of Specification and Out of Trend

Out of specification and out of trend are different concepts used in pharmaceuticals. Difference between OOT and OOS is explained here.
1. OOS (out of specification) is the comparison of one result versus predetermined specification criteria while OOT (Out of Trend) is the comparison of many historical data values versus time.

2. OOS investigations focus on determining the truth about that one value while OOT investigations focus on understanding non-random changes.
Example:
The specification limit for assay is: 95.0-105.0 % w/w of label claim

Case-1: For a particular batch, the result obtained 94.2 % w/w -This result is out of the specification limit. This is called OOS.

Case-2: The result obtained 95.8 % w/w. Although the results are well within the specifications, we should compare the result with the previous batches trend. If we found the average value of the trend as 99.0 % w/w then this batch result (95.8 % w/w) is called out of trend.

Also see:





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of pharmaguideline.com, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question


8 comments: Post Yours! Read Comment Policy ▼

  1. Nimesh Trivedi25 August

    how to prepare OOT SOP

    ReplyDelete
  2. how i can make a report of OOT

    ReplyDelete
  3. how far is it from trend average to be concluded as OOT? 5%? 10%? thanks.

    ReplyDelete
  4. SUPERB BLOG APPRECIATE THE EFFORTS

    ReplyDelete
  5. Hi oos is rised when only based on one time test result of an analyst of a sample

    ReplyDelete

Please don't spam. Comments having links would not be published.


Popular Categories

QA SOPs QC SOPs Micro SOPs HVAC Production SOPs Stores SOPs Checklists Maintenance SOPs HPLC Sterile GLP Validation Protocols Water System GDP Regulatory Maintenance Calibration Warning Letters Education B.Pharmacy
Online Courses


Follow Pharmaguideline


DOCUMENTS

PHARMACEUTICAL DOCUMENTS




Editable Pharmaceutical Documents in MS-Word Format. Ready to use SOPs, Protocols, Master Plans, Manuals and more...

View


adsbypg


Recent Posts