MODULE 12

Cleaning and analytical method validations

Aims

The aims of this module are to:

• provide the candidate with an understanding of analytical method validation including the approach to be taken when undertaking the complete validation of an analytical method in compliance with regulatory and professional guidelines.
• explain cleaning validation requirements and how it is completed.
• detail the documentation requirements for cleaning validation.

Learning outcomes

On completion of this module the student should be able to:

• understand the terms and definitions used in the analytical method validation.
• understand the purpose of validating an analytical method.
• know where to find relevant regulatory and professional validation guidelines and how they may be interpreted.
• understand the importance of validation of analytical methods in the context of the different phases of a pharmaceutical product life cycle.
• critically review validation data to assess the completeness and suitability of the information to use.
• describe important aspects of plant design to facilitate ease of cleaning.
• describe aspects required for manual and automatic cleaning procedures and be able tow rite a cleaning procedure.
• write a cleaning validation protocol.
• have a knowledge of the factors to be considered when developing a plan for the amount of cleaning validation required for a pharmaceutical facility.
• understand aspects of cleaning validation in primary and secondary pharmaceutical plants and biological production plants.
• understand processing aspects that have an effect on potential for cross contamination, and the GMP requirements for various types of active ingredients.
• describe a sample plan and understand the advantages and disadvantages of sampling methods.
• discuss the various methods of calculating cleaning limits for active ingredients, cleaning materials and microbiological contamination.
• understand how cleaning validation is performed.
• critically assess results and be able to document results and conclusions in cleaning validate reports.
• review of on-going cleaning validation and understand how to determine the amount of further on-going validation to maintain equipment an processes validated.
• understand various methods that can be used in normal production to obtain rapid assessment of cleaning efficacy.

TUTOR INFORMATION

Dr Ray Munden (analytical method validation)

MIke Radley (cleaning validaiton)