Robert G. Schwarz
GXP-TrainCon
Referent:innen
Have a brief look at the training here (link to YouTube). All times mentioned are CET. Book the Main Course in combination with the Pre-Course Workshop Impact of Annex 1 Revision on Cleaning Validation and save € 200!
Zielsetzung
Pre-Course
With the revised version of Annex 1 coming into force in August, this workshop 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 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.
With the revised version of Annex 1 coming into force in August, this workshop 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 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 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.
Hintergrund
Pre-Course
The Annex 1 Revision of the EU GMP Guide was finalised in 2022. Previously there were two drafts (2017 & 2020), now the final version will come into force at 25th August 2023. The new Contamination Control Strategy (CCS) hugely affects Cleaning Validation.
Main 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 it’s Contamination Control Strategy (CCS) also has an impact, especially on Cleaning Validation for sterile dosage forms.
Zielgruppe
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 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.
Programm
Pre-Course
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
Main Course
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
Q & A sessions
Five Q &A sessions (one during the pre-course, two on day 1 and on day 2 of the main course) ensure interaction and that your questions are answered.
Five Q &A sessions (one during the pre-course, two on day 1 and on day 2 of the main course) ensure interaction and that your questions are answered.
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This course is part of the GMP Certification Programme "ECA Certified Validation Manager"
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