OOS Investigations in a GMP Environment

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This course is designed to provide essential training for conducting Out of Specification (OOS) investigations in a GMP environment. A background discussion of the associated GMP documentation required to support the OOS investigation is included but the majority of time is spent detailing the who, what, when, how and why of the investigation, determining the extent of the investigation during Phase I and Phase II, documenting findings determining root causes and assigning corrective and preventative actions. An introduction to OOT (Out of Trend) results and an overview of the different types and how they are typically handled is also discussed using industry examples in the first session of this course.

This course is presented in a dynamic environment created by a power point presentation, interactive exercises, case studies and group discussion. Participants are welcome to bring their own examples for group discussion sessions.

The workshop emphasizes practical issues such as:

  • What is an OOT"
  • The importance of good quality support systems
  • FDA audit observations and how they could have been avoided
  • Case studies for OOS results
  • A detailed guide to conducting Phase 1 and Phase II of the OOS investigation
  • Reporting and evaluating passing and failing results

The course provides ample opportunities for group discussions, case studies and exercises. It enables participants to gain the skills and knowledge necessary to meet current regulatory expectations. The course material is based on the FDA guideline 'Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production', October 2006 and MHRA guidance published in 2012.

Questions and answers will be taken throughout the duration of the course.

Day 1

8.30 Registration and Coffee

Morning Session 1 – 9.00 to 10.30am

  • Introduction and definition of OOT/OOS
  • Out of Trend Results
  • Defining the main categories of OOS results
  • Review of FDA’s guidelines (Oct 2006)
  • Examples and case studies of regulatory observations

10.30 Morning refreshments

Morning Session 2 –
10.45 am to 12.30pm

  • Quality documentation required to support OOS investigations Responsibilities
  • Defining the main categories of OOS results
  • Investigating OOS results – Phase 1
  • Flow chart
  • Checklist

12.30 Lunch

Afternoon Session 1 – 13.30 to 15.15pm

  • Investigating an OOS result Phase 1 (continued)
  • Determining the root cause
  • Common Laboratory errors
  • Regulations and industry response to invalidating OOS results

15.15 Afternoon refreshments

Afternoon Session 2 – 15.30 to 17.30pm

  • Phase 1 Case studies
  • These are interactive group exercises where the participants utilise their experience and new learning to figure out more appropriate action than that which was taken as described in the examples. Their answers are then compared to the actual FDA response. Group discussions follow.

17.30pm End of day

Day 2

Morning Session 1 – 9.00 to 10.30am

  • Investigating OOS results Phase 2
  • Flow chart
  • Checklist
  • Examples of root causes found during Phase 2 investigation

10.30 Morning refreshments

Morning Session 2 – 10.45 am to 12.30pm

  • Case studies Phase 2

12.30 Lunch

Afternoon Session 1 – 13.30 to 15.15pm

  • Additional Laboratory Testing (Retesting and Resampling)
  • Reporting Test Results
  • Concluding the Investigation and Evaluating the results

15.15 Afternoon refreshments

Afternoon Session 2 – 15.30 to 17.00pm

  • Corrective and Preventative Actions
  • The Audit Trail
  • Minimising future OOS results

17.00pm End of day



This Two-day course is valuable for Directors, Managers, Supervisors, Laboratory Analysts and Associates working in a GMP environment in the Pharmaceutical and related industries with daily responsibilities in the following areas:

  • Quality Assurance
  • Documentation and Technical Writing
  • Quality Control Laboratory
  • Regulatory Affairs
  • Contract Laboratory
  • Analytical Laboratory
  • Project Management
  • Training


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