Cleaning Validation AND Post-Course: Impact of Annex 1 Revision on Cleaning Validation - Live Online Training
5-7 May 2025
Course No. 21791
Speakers
Robert G. Schwarz
GXP-TrainCon
Have a brief look at the training here (link to Vimeo). All times mentioned are CEST. Book the Main Course in combination with the Post-Course Impact of Annex 1 Revision on Cleaning Validation and save € 200!
Objectives
Post-Course: With the revised version of Annex 1 that became effective in August 2023, this course aims at giving you an overview of important changes that impact cleaning and Cleaning Validation which may not be seen at the first glance. As integral topic of the new Contamination Control Strategy (CCS), it will also be in the main focus of authorities during inspections of sterile medicinal products. Some of the strategies in Annex 1 may even become “state of the art” for non-steriles in the upcoming years. This is already explicitly mentioned in the scope of the new Annex 1. It will be elaborated how to align your Cleaning Validation strategy with this, highlighting points to consider when implementing those changes in requirements into your daily Cleaning Validation Business.
Main Training Course:
Many questions relative to cleaning validation are still open and have to be answered within the companies:
What should the cleaning validation concept 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 residue value is scientifically acceptable?
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 verification the solution for infrequently manufactured products?
Which microbiological maximum residue values are valid in the areas of non-sterile dosage forms and APIs? and
What are special aspects of cleaning validation in biotech API plants?
These questions will also be discussed with the help of practical examples.
Background
Post-Course:
The Annex 1 Revision of the EU GMP Guide was finalised in 2022. Previously there were two drafts (2017 & 2020), the final Version became effective on 25th August 2023. The new Contamination Control Strategy (CCS) hugely affects Cleaning Validation.
Main Training Course:
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 its Contamination Control Strategy (CCS) also has an impact, especially on Cleaning Validation for sterile dosage forms.
Target Group
The Post-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.
Date & Technical Requirements
Date Main Course: Cleaning Validation Monday, 05 May 2025, 09:00 – 17.00h (CEST) Tuesday, 06 May 2025, 08.30 – 16.30 h (CEST)
Post-Course: Impact of Annex 1 Revision on Cleaning Validation Wednesday 07. May 2025, 09.00 – 12.30 (CEST)
Technical Requirements We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
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
Q & A sessions Five Q &A sessions ( two on day 1 and on day 2 of the main Course and one during the post-course) ensure interaction and that your questions are answered.
Post-Course
With the Post-Course 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!?
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Testimonials
Seminar Programme as PDF