GMP Certification Programme

Certified Validation Manager

Speakers

Cleaning Validation
Dr Martina Breuer
Haupt Pharma Münster,
Germany
03/04 November 2022 | Heidelberg, Germany

Walid El Azab
STERIS Corporation, Belgium

Peter Mungenast
Merck, Germany

Robert G. Schwarz
FH Campus Vienna, Austria

With 4 Parallel Workshops

Highlights
ƒ APIs and Pharmaceuticals
ƒ Cleaning Validation Concepts
ƒ Cleaning validation protocol and report
ƒ Risk Management
ƒ Pitfalls and findings in inspections/Warning Letters
ƒ Is cleaning evaluation accepted by GMP
ƒ Special Aspects of Cleaning Validation
ƒ Validation of holding times
ƒ Acceptance Criteria: PDE vs others
ƒ Technical and Organisational Aspects on Equipment
ƒ Cleaning Validation in Biotech API Plants

Free Download: ECA‘s Good Practice Guide

„Integrated Qualification and Validation“
Programme

Objective
In the manufacture of medicinal products and APIs, the cleaning
of facilities and equipment is an important measure to avoid 4 Parallel Workshops
contamination and cross contamination. In compliance with the
GMP regulations, cleaning is performed and documented ac-
cording to the described procedures. In the past, cleaning effec- 4 Parallel workshops, concentrating on medicinal products,
tiveness was often monitored only visually. However, residuals chemical and biological manufactured APIs, and about the
of APIs and excipients as well as of detergents are increasingly organisation of cleaning validation guarantee the practical
an issue in inspections and audits. The success of cleaning proce- orientation.
dures has to be validated. In addition to the FDA “Guide to In-
spection of Cleaning Validation”, the PIC/S document PI 006 and Please choose your workshop when registering.
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 as-
sociation of European API manufacturers.

A new Guideline from EMA on Dedicated Facilities and Exposure Programme

Limits for Cleaning Validation and the revised Annex 15 now
deal with a PDE (Permitted Daily Exposure) approach. Cleaning validation landscape from start to end

ƒ Cleaning design and processes

Background - Type and selection of cleaners
- Soil residue evaluations (Worst Case selection)
Many questions relative to cleaning validation are still open and ƒ Determination of the critical parameter (SMART objective)
have to be answered within the companies: ƒ Sampling selection based on a risk-based
assessment
ƒ What does the cleaning validation concept have to look ƒ Cleaning documentation life cycle
like to be GMP-compliant and cost-effective?
ƒ Which risk analyses are applicable to cleaning validation?
ƒ How helpful can a riboflavin test be? Cleaning Validation Concepts
ƒ Which maximum value is scientifically acceptable,
especially in the field of APIs? ƒ Introduction of relevant Guidelines
ƒ Which sampling procedure is appropriate for which ƒ CV Concepts
process and facility? ƒ CV Risk Management
ƒ How can you cut costs by means of bracketing? ƒ CV Plan
ƒ How are critical areas defined? ƒ CV Report
ƒ Is cleaning evaluation the solution for seldom manufac- ƒ CV Revalidation, CV Verification
tured products? ƒ Typical inspection findings, warning letters
ƒ Which microbiological maximum values are valid in the
areas of non-sterile dosage forms and APIs?
and Cleaning Validation in Biotech API Plants
ƒ Special aspects of cleaning validation in biotech API plants
ƒ What is different between chemical and biotech APIs?
These questions will also be discussed with the help of practical ƒ Acceptance criteria for biotech APIs
examples. ƒ What is the adequate analytical method to detect biotech
APIs in cleaning validation

Target Audience
Special Aspects of Cleaning Validation
This course is directed at staff of R&D, production and quality as-
surance involved in cleaning validation. It also addresses engi- ƒ Acceptance criteria
neering companies interested in learning more about the phar- ƒ Cleaning methods: CIP, WIP, manual cleaning
maceutical industry‘s viewpoint and in exchanging experiences. ƒ Random Controls
Note: The number of participants is limited. ƒ Hold time studies: DHT, CHT
ƒ Validation of analytical methods used for CV
Accessories: Please bring along a pocket calculator.

Cleaning Validation | 03/04 November 2022, Heidelberg, Germany

 Speakers

Cleaning Evaluation and Validation in Chemical Speakers

API Production

ƒ Differences regarding cleaning in API production to the Dr Martina Breuer

production of medicinal products Haupt Pharma Münster GmbH
ƒ The challenges of API production
- Acceptance criteria Martina Breuer studied pharmacy at the University in Munster.
- Adequate sampling She has more than 20 years experience in pharmaceutical
ƒ Is cleaning evaluation accepted by GMP? industry and was employed in various positions in Quality con-
trol, Production and in Quality assurance. Since 2008 she is
Head of Quality assurance at the Aenova site in Munster respon-
Technical and Organisational Aspects on Equipment sible for the quality system to be compliant with EU-GMP and
Regarding Cleaning Procedures CFR requirements.

ƒ Design and material aspects

ƒ Requalification Walid El Azab
ƒ CIP aspects STERIS Corporation, Belgium
- Riboflavin test
- Maintenance Walid El Azab is a Technical Services Manager for the Life Sci-
ences Division of STERIS Corporation. He currently provides
technical support related to cleaning chemistries, disinfectants
How to write a Cleaning Validation Protocol and sterility assurance products and their application and vali-
dation. His areas of expertise include both upstream and down-
ƒ Team and project validation creation (benchmarking best stream biopharmaceutical operation and validation. Walid has
practice) held various positions including Project Manager, Inspection
ƒ GMP requirements and best practice for a protocol Readiness Manager, Quality and Regulatory Manager, and Qual-
redaction and content ified Person (QP). Walid earned a Master’s degree in Industrial
ƒ Quality attribute to be tested for non- and sterile Pharmaceutical Sciences from the University of Liege, Belgium
manufacturing and is green belt certified.
ƒ Sampling and analysis methods overview
ƒ Examples through a case study – validation and imple-
mentation in routine Peter Mungenast
Merck KGaA

He studied Biology and Chemistry at the University in Karlsruhe.

Then he worked in different functions for Merck KGaA. Since
Social Event 1996 in the Quality Assurance department responsible for clean-
ing validation, training and different projects.
In the evening of the first day, you are cordially invited to a social
event. This is an excellent opportunity to share your experiences
with colleagues from other companies in a relaxed atmosphere. Robert G. Schwarz
FH Campus Vienna, Austria

Robert G. Schwarz studied biotechnology and quality manage-

ment. After working in a medicinal lab as medical/technical ana-
lyst Robert G. Schwarz joined Shire (formerly Baxter), Vienna in
2001. Until 2005 he was coordinator of environmental monitor-
ing. From 2005 until 2018 he was validation specialist responsi-
ble for equipment qualification, sterilisation validation and
cleaning validation. Additionally since 2010 he is university lec-
turer in the field of biotech (core topics validation/qualification,
aseptic processing, cleanroom technologies and QC).

Cleaning Validation | 03/04 November 2022, Heidelberg, Germany

 If the bill-to-address deviates from the specifica- Reservation Form (Please complete in full)
tions on the right, please fill out here:
Cleaning Validation, 03/04 November 2022, Heidelberg, Germany
____________________________________ WORKSHOPS: Please indicate your choice (tick only one)
… Workshop 1: Cleaning Validation regarding Medicinal Products
____________________________________ … Workshop 2: Cleaning Validation regarding chemical API manufacturing
… Workshop 3: Cleaning Validation regarding biological API manufacturing
____________________________________ … Workshop 4: Develop a Cleaning Validation procedure from start to end

____________________________________
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