With the Pre-Course Workshop we cover:
- Regulatory requirements of Annex 1 regarding Cleaning Validation & Cleaning (incl. potential topics stated "between the lines")
- Annex 1, Annex 15 and EMA "Shared facilities Guideline" – harmonized, extended requirements or even contradictions!?
- Annex 1 & Cleaning Validation – practical approaches
- EU GMP Guideline Part I, II and III
- EU GMP Guideline Annex 15
- EMA "Shared Facilities Guideline" (incl. PDE concept)
- PIC/S PI 006
- APIC Cleaning Validation Guideance for APIs
- PDA TR 29 – "Points to Consider for Cleaning Validation"
- FDA 21 CFR 211.67
- FDA Guide to Inspection – Validation of Cleaning Processes
Practical Pre-Requisites I – Hygenic Equipment Design
- What is hygenic design?
- Material aspects
- WIP/CIP aspects
- Riboflavin test
Practical Pre-Requisites II – Cleaning Process Development
- Developing a cleaning process – which steps are necessary?
- Which residues are common
- Type and selection of cleaners
- CIP vs WIP vs manual cleaning
- Cleaning Documentation
Q & A
Sampling during Cleaning Validation
- Sampling during Cleaning Validation
- How to define sampling points?
- Sampling techniques
- Analytical requirements
Live Workshop – Setting Sampling Points
- Setting sampling points on a risk-based approach – what to consider
- Sampling point selection based on sampling technique and analytical method
- Different sampling points for different purposes
Q & A
Cleaning Validation – incl. Practical Approaches
- Cleaning Validation Concepts
- Hold time studies (DHT, CHT)
- Cleaning Validation Risk Management
- Cleaning Validation Plan
- Cleaning Validation Report
- Cleaning Validation life cycle (Revalidation, Ongoing Cleaning Verification)
- Cleaning Evaluation
Handling Deviations and OOS during Cleaning Validation and Ongoing Cleaning Verification
- What is an OOS, what a deviation regarding Cleaning Validation?
- GMP-compliant documentation of OOS and deviations
Q & A
Live Workshop – Case studies of Non-Conformities during Cleaning Validation and Ongoing Cleaning Verification
- Is always the cleaning process to blame?
- Which actions are adequate based in the investigation and root cause?
- Actions dfepending on the time-point of detecting the Non-Conformity
- Does a Non-Conformity mean revalidation?
- Does a Non-Conformity always lead to batch rejection?
Special Topics of Cleaning Validation
- Segregation & shared facility guideline
- Cleaning Validation in Biologics & Biotech production
- Differences between chemical and biotech APIs
- Acceptance criteria for biotech APIs
- Analytical methods to detect biotech APIs in Cleaning
Q & A