QbD and Lifecycle Management for Analytical Methods

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Description

The pharmaceutical industry is starting to apply a Quality by Design (QbD) approach to the development of pharmaceutical products. It follows therefore, that the analytical procedures which are used to test these products throughout their lifecycle could also benefit from such an approach. This approach encompasses understanding variables and optimising a control strategy using tools such as risk assessment and Design of Experiments (DOE) in order to provide scientific rationale for the choices made during the process. Using the QbD and lifecycle management approach during analytical method development and qualification will result in more robust methods which produce consistent, reliable, quality data throughout the lifecycle. This, in turn, will lead to less method transfer failures, OOS results and method "incidents" when used in the routine environment.

This two day training course presents a brief overview of method validation according to ICHQ2 (R1) and discusses the limitations of this approach in terms of its contribution to failure of methods with regards to method transfer and generation of OOS results later in the method lifecycle. It then illustrates that the lifecycle approach is a holistic process which embraces the philosophies of the traditional approach but results in more robust analytical procedures. Finally a comparison of the current approach (ICHQ2) and the QbD approach is presented.

The course focuses on HPLC methods; therefore experience in developing, validating and transferring analytical HPLC methods would be an advantage to participants.

The material is presented by means of slides, handouts and participation of the attendees through discussion, case studies and hands on group exercises.

Overview

This course is designed to provide training in how to apply Quality by Design and lifecycle management to the development and qualification of analytical methods.

It aims to highlight the limitations of the current approach to method validation (ICHQ2) and the benefits to using the QbD approach. Although the QbD and Lifecycle management approach is not yet officially recognised for analytical methods, the course is based on the approach used for manufacturing processes and products as described in ICH Q8, Q9 and Q10.

The course emphasises practical issues such as:

  • Comparison of the traditional approach and QbD/lifecycle approach to analytical methods
  • Applying the QbD and lifecycle approach to development and qualification of analytical methods
  • Exploring and controlling variables of analytical methods

This course will deliver the tools to enable you to:

  • Consider a QbD and lifecycle management approach to analytical methods
  • Define an Analytical Target Profile
  • Recognise the importance of understanding method variables of individual methods
  • Develop more robust analytical methods

Who Should Attend?

This 2 day course is valuable for Managers, Supervisors, Laboratory Analysts and Associates involved in the development, validation, transfer or review of analytical methods in the Pharmaceutical and related industries with daily responsibilities in the following areas:

  • Quality Assurance
  • Quality Control Laboratory
  • Regulatory Affairs
  • Contract Laboratory
  • Analytical Development Laboratory
  • Training

Course Programme

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

Day 1

8.45 am Registration and Coffee

9.15am

  • Introduction
  • Traditional approach to validation (ICHQ2)
  • Exercise
  • The limitations of this approach

10.45am Morning refreshments

11.00 am to 12.30pm

  • Discussion of current approach (Groups share experiences of method problems)
  • Definition of QbD
  • Overview of ICH Q8, Q9 and Q10
  • Applying QbD to analytical methods (The three stages)

12.30 pm Lunch

1.30 pm to 3.00 pm

Stage 1

  • Gather Knowledge
  • The Analytical Target Profile
  • Exercise

3.00 pm Afternoon refreshments

3.15 pm to 4.30pm

Method design and Method Understanding

  • Risk assessment (exercise)
  • Understanding and controlling variables (Robustness and Ruggedness)

Day 2

9.00 am to 10.15 am

Practical Experiment

10.15 am Morning refreshments

10.30 am to 12.00 pm

  • Robustness study
  • Design of experiments

12.00pm Lunch

1.00pm - 2.30 pm

  • Ruggedness study
  • Conclusion of Stage 1

2.30 pm Afternoon refreshments

2.45 pm to 4.30 pm

Stage 2 - Procedure Performance Qualification

Stage 3 - The lifecycle approach

  • Continued method verification
  • Quality systems - Change control and trending
  • How can the QbD approach to translate to less method transfer failures"
  • Overview Comparison of Traditional and QbD approach
  • Advantages of QbD

4.30 pm End of course

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