Who should investigate OOS?
When an OOS occurs, it must be investigated in the laboratory. Requirements for conducting laboratory investigations have been set by the United Kingdon’s Medicines and Health Care Products Regulatory Agency (MHRA) and FDA. Most companies aim to complete the initial Phase I lab investigation within 10 days.
How many phases are there in OOS investigation?
2 phases
The OOS investigation involves 2 phases.
What is the purpose of an OOS investigation?
The objective of an OOS investigation is to determine whether the out of specification result is true or if there is an assignable cause.
What is hypothesis testing in OOS investigation?
The hypothesis test plan should pre-define the expected criteria/results to prove or disprove a hypothesis. If a confirmed laboratory root cause is identified which supports the invalidation of the OOS result, then testing to replace the original OOS result can be justified.
What is the major cause of OOS?
It is more typical that a system failure permitted an individual to initiate a course of action that generated OOS/OOT results. The causes of which may include: unclear or complex processes, poor training, time/resource pressures, etc.
What is Capa in pharma?
(Corrective and Preventive Actions) A structured approach to the investigation process should be used with the objective of determining the root cause.
What is pharma investigation?
Investigation: A documented logical and/or scientific review of data related to all quality events that lead to the identification of the root cause and corrective and preventive action.
What is the difference between OOS OOE oot?
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.
What is OOS and OOE?
These deals with handling of deviating analysis results. Out-of-Specification (OOS) Results. A result that falls outside established acceptance criteria which have been established in official compendia and/or by company documentation. Out-of-Expectation (OOE) Results.
When do you need to do Oos / oot investigation?
By comparison the MHRA guidance states that OOS/ OOT investigation must be conducted for: Batch release testing and testing of starting materials IPC testing if data is used for batch calculations/decisions and if in dossier or on the Certificate of Analysis Stability studies for marketed finished products and/or APIs
When is Phase II of an MHRA investigation conducted?
Phase II Investigations: This phase of investigation is conducted when the phase I investigations did not reveal an assignable laboratory error.
How does out of specification ( OOS ) guidance work?
The guidance offers a stepwise approach on what should be considered at each stage of the investigation. It contains flowcharts that simplify the recommended actions on discovering an OOS and covers the following key areas and highlights. “Investigations of Out of Specification (OOS)/Out of Trend (OOT)/Atypical results have to be done in cases of:
When to use hypothesis testing in an OOS investigation?
Hypothesis testing is a very useful tool in an OOS investigation to explore theories as to what may have gone wrong. Though its use is permitted as early as Phase 1 investigation and may carryover into Phase 2 investigation, there are some risks with