GMP Certification Programme

Certified Validation Manager

Speakers

Cleaning Validation
Dr Martina Breuer
Haupt Pharma Münster GmbH, 17/18 March 2020 | Berlin, Germany
Germany

Walid El Azab
STERIS Corperation, Belgium

Peter Mungenast
Merck, Germany

Robert Schwarz
FH Campus Vienna, Austria

With 4 Parallel Workshops

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

Free Download: ECA´s Modern

Qualification Good Practice Guide
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

ƒƒ 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 ƒƒ Determination of the critical parameter (SMART objective)
have to be answered within the companies: ƒƒ Sampling selection based on a risk-based
assessment
ƒƒ What does the cleaning validation concept have to look ƒƒ Cleaning documentation life cycle
like to be GMP-compliant and cost-effective?
ƒƒ Which risk analyses are applicable to cleaning validation?
ƒƒ How helpful can a riboflavin test be? Cleaning Validation Concepts
ƒƒ Which maximum value is scientifically acceptable,
especially in the field of APIs? ƒƒ Introduction of relevant Guidelines
ƒƒ Which sampling procedure is appropriate for which ƒƒ CV Concepts
process and facility? ƒƒ CV Risk Management
ƒƒ How can you cut costs by means of bracketing? ƒƒ CV Plan
ƒƒ How are critical areas defined? ƒƒ CV Report
ƒƒ Is cleaning evaluation the solution for seldom manufac- ƒƒ CV Revalidation, CV Verification
tured products? ƒƒ Typical inspection findings, warning letters
ƒƒ Which microbiological maximum values are valid in the
areas of non-sterile dosage forms and APIs?
and Cleaning Validation in Biotech API Plants
ƒƒ Special aspects of cleaning validation in biotech API plants
ƒƒ What is different between chemical and biotech APIs?
These questions will also be discussed with the help of practical ƒƒ Acceptance criteria for biotech APIs
examples. ƒƒ 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- ƒƒ Acceptance criteria
neering companies interested in learning more about the phar- ƒƒ Cleaning methods: CIP, WIP, manual cleaning
maceutical industry‘s viewpoint and in exchanging experiences. ƒƒ Random Controls
Note: The number of participants is limited. ƒƒ Hold time studies: DHT, CHT
ƒƒ Validation of analytical methods used for CV
Accessories: Please bring along a pocket calculator.

Cleaning Validation | 17/18 March 2020, Berlin, Germany

 Speakers

Cleaning Evaluation and Validation in Chemical Speakers

API Production

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

production of medicinal products Haupt Pharma Münster GmbH
ƒƒ 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
ƒƒ 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.

ƒƒ Design and material aspects

ƒƒ Requalification Walid El Azab
ƒƒ CIP aspects STERIS Corperation, 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-
ƒƒ Team and project validation creation (benchmarking best stream biopharmaceutical operation and validation. Walid has
practice) held various positions including Project Manager, Inspection
ƒƒ 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
ƒƒ Quality attribute to be tested for non- and sterile Pharmaceutical Sciences from the University of Liege, Belgium
manufacturing and is green belt certified.
ƒƒ Sampling and analysis methods overview
ƒƒ 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
1996 in the Quality Assurance department responsible for clean-
ing validation, training and different projects.

Robert Schwarz
Social Event FH Campus Vienna, Austria

In the evening of the first day, you are cordially invited to a social Robert Schwarz studied biotechnology and quality manage-
event. This is an excellent opportunity to share your experiences ment. After working in a medicinal lab as medical/technical ana-
with colleagues from other companies in a relaxed atmosphere. lyst Robert 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 | 17/18 March 2020, Berlin, Germany

 If the bill-to-address deviates from the Reservation Form (Please complete in full)
specifications on the right, please fill out here:
Cleaning Validation, 17/18 March 2020, Berlin, 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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