Aims and Objectives
This subject aims to extend the principles presented in HES6403 (Validation
Principles) to practical outcomes. The subject covers application of statistical data analysis in validation, how to conduct cleaning validation, practical workshops in preparing validation protocols, validation of solid dose forms and liquids/creams and special requirements for the validation of biotechnology products.
On completion of this subject students will be able to:
- Develop cleaning validation programs
- Develop User Requirement Specifications and Design Qualification Protocols.
- Develop protocols for equipment qualification
- Develop protocols for process validation.
- Outline a risk-based approach to the validation of liquids, solid-dose, biotechnology and sterile products.
- Apply basic statistical techniques to assist in developing scientific acceptance criteria
Content
This subject consists of 5 modules or topics:
#1 Cleaning Validation:
This module covers the cGMP requirements for cleaning validation programs and includes a review of FDA and European regulatory expectations. It discusses, with examples, current industry practices and compliance strategies.
- Interpret regulatory requirements and guidelines.
- Apply risk management principles to identify cleaning validation parameters.
- Establish residue limits and calculate sample acceptance criteria to define clean.
- Select sampling and analytical methods to measure cleaning.
- Prepare cleaning validation protocols
#2 Preparing Validation Protocols: (URS, DQ and Equipment Qualification Protocols)
This module gives hands-on experience in preparing validation protocols. It provides a risk-based approach to equipment qualification based on ISPE Baseline Guides and the recently published ASTM250 Guideline.
- Develop a URS and evaluate it against the Functional Specifications and Design Specifications
- Apply risk management principles to qualification
- Develop a DQ for production equipment
- Develop IQ and OQs for production and plant equipment
#3 Process Validation of Solid Dose Forms and Liquids/Creams
This module gives hands-on experience in preparing process validation protocols. A provides a risk-based approach to process validation based on current regulatory and international guidance.
- Apply risk management principles to process validation.
- Compare and contrast Performance Qualification and Process Validation.
- Identifying critical process steps.
- Develop a validation protocol for a liquid manufacturing process.
- Develop a validation protocol for a solid dose manufacturing process.
#4 Process Validation of Biotechnology Products
This module covers the requirements for process validation of biotechnology and sterile products.
- State the critical steps requiring process validation of fermentation
- State the critical steps requiring process validation of chromatography
- Develop a process validation plan for a typical biotech manufacturing pathway
- List typical industry acceptance criteria
#5 Retrospective Reviews and Statistical Data Analysis
This module introduces the participants to basic statistical techniques to assist them in developing scientific acceptance criteria and preparing reports.
- Analyse control charts and capability analysis in periodic reviews
- Differentiate between a retrospective review and retrospective validation
- Use statistical methods to evaluate validation data
- Prepare a retrospective review protocol
