Many questions relative to cleaning validation are still open and have to be answered within the companies:
What does the cleaning validation concept have to look like to be GMP-compliant and cost-effective?
Which risk analyses are applicable to cleaning validation?
How helpful can a riboflavin test be?
Which maximum value is scientifically acceptable, especially in the field of APIs?
Which sampling procedure is appropriate for which process and facility?
How can you cut costs by means of bracketing?
How are critical areas defined?
Is cleaning evaluation the solution for seldom manufactured products?
Which microbiological maximum values are valid in the areas of non-sterile dosage forms and APIs?
and
Special aspects of cleaning validation in biotech API plants
These questions will also be discussed with the help of practical examples.
Background
In the manufacture of medicinal products and APIs, the cleaning of facilities and equipment is an important measure to avoid contamination and cross contamination. In compliance with the GMP regulations, cleaning is performed and documented according to the described procedures. In the past, cleaning effectiveness was often monitored only visually. However, residuals of APIs and excipients as well as of detergents are increasingly an issue in inspections and audits. The success of cleaning procedures has to be validated. In addition to the FDA “Guide to Inspection – Validation of Cleaning Validation Processes”, the PIC/S document PI 006 and Annex 15 address cleaning validation in a separate chapter. Moreover, the ICH Guideline Q7 “GMP for APIs” also requires cleaning validation – as well as two Guidelines by APIC, the association of European API manufacturers.
A Guideline from EMA on Dedicated Facilities and Exposure Limits for Cleaning Validation and the revised Annex 15 deal now with a PDE (Permitted Daily Exposure) approach.
The Annex 1 revision and it’s Contamination Control Strategy (CCS) also has an impact, especially on Cleaning Validation for sterile dosage forms.
Target Group
The Pre-Course and the Main Course both are directed at staff of R&D, production and quality assurance involved in cleaning validation. They also address engineering companies and manufacturers of cleaning devices/equipment interested in learning more about the pharmaceutical industry’s viewpoint and in exchanging experiences.
Technical Details
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration: When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate: The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Programme
Regulatory Requirements
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 Guidance for APIs
PDA TR 29 – “Points to Consider for Cleaning Validation
ISPE Cleaning Validation Life Cycel – Applications, Methods, and Controls
FDA 21 CFR 211.67
FDA Guide to Inspection – Validation of Cleaning Processes
Practical Pre-Requisites I – Hygienic Equipment Design
What is hygienic design?
Material aspects
WIP/CIP aspects
Riboflavin test
Practical Pre-Requisites II – Cleaning Process Development
Developing a cleaning process – which steps are necessary?
TACT
Which residues are common
Type and selection of cleaners
CIP vs WIP vs manual cleaning
Cleaning Documentation
Sampling during Cleaning Validation
How to define sampling points?
Sampling techniques
Swab
Rinse
Coupons
Analytical requirements
Cleaning Validation – incl. Practical Approaches
Cleaning Validation Concepts
Bracketing
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
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
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
CAPA
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 on the Investigation and root cause?
Actions depending 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 Validation
Recording from 5/6 May 2025 Duration of the Recording: approx. 09 h 15 min
This course is part of the GMP Certification Programme "ECA Certified Validation Manager" Learn more
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