ceutical Packaging Materials

Save € 300,- and book both courses simultaneously!
Quality Control
Compliance Week
4 - 7 May 2009, Vienna, Austria
Quality Control of
Raw Materials
4-5 May 2009, Vienna, Austria
� Regulatory Requirements for APIs and
Excipients
� Current GMP Requirements for APIs,
Excipients and Drug Products
� Laboratory Organisation
� Pharmacopoeias
� Sampling of Incoming APIs and Excipients
� Reduced Testing of Supplied APIs
and Excipients
� Analytical Methods
� NIR (Near InfraRed Spectroscopy) for an
Efficient Control of Raw Materials
QC and QA of Pharma-
ceutical Packaging Materials
6-7 May 2009, Vienna, Austria
� Regulatory Requirements on Pharmaceutical
Packaging Materials: EU and US
� Instrument Calibration and Qualification
in the QC Packaging Laboratory
� Defect Evaluation Lists
� Control of Dimensions / Control of Printed
Packaging Materials
� IR for Packaging Materials: Benefits and Limits
� cGMP-Compliant Documentation of
Packaging Control Activities
� Sampling and Testing of Packaging
Materials - Practical Examples
� Testing of Extractables/Leachables

Quality Control of Raw Materials
4 – 5 May 2009, Vienna, Austria
Objectives
Testing active pharmaceutical ingredients and excipients
is one of the main tasks of the quality control units in the
pharmaceutical industry. It must be ensured that the necessary
tests are conducted on the incoming goods and
that the starting materials are released only after their
quality was judged as satisfactory. This GMP Education
Course about the incoming goods control of APIs and
excipients will give you a comprehensive overview of the
specific tasks and questions of the „raw materials lab“
and show you real-life solutions and answers.
This course will deal among others with the following
questions:
� Who is responsible for the release or rejection of starting
materials?
� How can the incoming goods lab be organised efficiently?
� Which SOPs are necessary?
� In which cases can test results be taken over from the
supplier‘s certificate of analysis?
� Do all test items of a pharmacopoeial monograph
have to be analysed?
� Are the pharmacopoeial monographs similar, or must
different tests be conducted for PhEur, USP and JP?
� Can a pharmacopoeial test method be replaced by an
alternative test method? Does this require a variation
application?
It is the aim of this GMP Education Course to give answers
to these and many other important questions relating
to the testing of APIs and excipients and to serve as a
forum for an intensive experience exchange.
Target Group
This Education Course is directed at all those employees
from quality control units in the pharmaceutical industry
(including heads of quality control and laboratory managers)
who are competent or responsible for sampling,
testing and release of the starting materials used (= APIs
and excipients).
This course is also of interest to personnel from quality
assurance and to those employees from API and excipient
manufacturers who want to inform themselves about
the requirements of the pharmaceutical industry on the
testing of these starting materials.
Programme
Regulatory Requirements for APIs and Excipients
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Definition of APIs and excipients
EU Requirements
FDA Requirements, e.g. FDA Draft Guidance “Drug
Product”
Common Technical Document (CTD)
Certification Procedures:
- EDQM Certificate of Suitability
- Active Substance Master File
- US - Drug Master File
Quality Standard: How to discern a good starting
material from a bad one?
DR RETO THEISS, Merck KGaA
Current GMP Requirements for APIs, Excipients and
Drug Products
� Relevant ICH guidelines
� EU regulations for Drug Products and API
� GMP for excipients – current expectations
� IPEC (International Pharmaceutical Excipients Council)
Guideline for excipients
� Upcoming EU GMP regulation for excipients
� GMP aspects of supplier/manufacturer qualification
DR THOMAS STORM, Novartis Pharma AG
Laboratory Organisation
� Role of the raw materials laboratory within the pharmaceutical
supply chain
� Optimization of the analytical laboratory with respect
to costs, time and resources (economic order size,
costs of analysis vs stock keeping costs, involvement of
RM suppliers in the SC)
EMERICH GRASSINGER, Boehringer Ingelheim
Pharmacopoeias
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Regulatory background
Pharmacopoeial institutions – Ph.Eur., USP/NF, JP
CEPs
Implementation of pharmacopoeial monographs in
your laboratory
Multi-compendial testing
Validation of pharmacopoeial testing methods
New USP General Chapter Verification of
Compendial Methods
DR THOMAS STORM, Novartis Pharma AG
Sampling of Incoming APIs and Excipients
� Regulatory requirements
� Are the requirements the same for active and excipients?
� Sampling plans
� Training
� GMP-compliant documentation of sampling operations
� Practical examples
EMERICH GRASSINGER, Boehringer Ingelheim

WORKSHOP I
Sampling
� Examples for generating sample procedures
� How to deal with the unexpected?
� How to deal with deviations on the delivery like incorrect
temperature control, stacked up pallets, etc.?
Moderator:
EMERICH GRASSINGER, Boehringer Ingelheim
Reduced Testing of Supplied APIs and Excipients
� What guidance is available on reduced QC testing?
� EU- and FDA expectations?
� Supplier qualification as a prerequisite
� Other information required before you start reducing
� Can APIs and excipients be covered within the same
approach?
� Who is in the driver seat, who must be involved?
� Practical execution
DR RETO THEISS, Merck KGaA
WORKSHOP II
Reduced Testing
Apart from any guidance, it is still much up to the manufacturer
to decide which APIs and which excipients
might be subject of a reduced testing procedure. Since
the quality of the substance has to be assured without
compromise, multiple factors must be considered before
the full testing of every single batch can be reduced.
It is the aim of this workshop to exchange information
about different approaches and to discuss their
advantages and disadvantages respectively considering
the actual guidance as well as their practicability.
Moderator: DR RETO THEISS, Merck
Analytical Methods
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Use and validation of non-compendial methods
How to proof comparability?
Advantages of instrumental methods versus visual
methods
Handling of deviations (Out-of-Specification results
and complaints)
CAPA process
Measurement system analysis
Documentation
Retests
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EMERICH GRASSINGER, Boehringer Ingelheim
NIR (Near InfraRed Spectroscopy) for an Efficient
Control of Raw Materials
� A short introduction to NIR Spectroscopy
� NIR as a pharmacopoeial monograph
� NIR for single container identification
� Costs vs. benefit
ARMIN GROH, Nycomed GmbH
Speakers
Emerich Grassinger
Boehringer Ingelheim Pharma GmbH & Co.KG,
Ingelheim, Germany
Emerich Grassinger started at Boehringer Ingelheim
as the head of an analytical laboratory in the
API production. Since 2006 he is responsible for
the Raw Material laboratory in which the testing and release of
the API`s and excipients is carried out. In this function he is
further more responsible for the sampling of the Raw Materials.
Armin Groh
Nycomed GmbH, Singen, Germany
Armin Groh works as head of laboratory in the
QC unit of Nycomed in Singen, Germany. He is
responsible for various analytical methods like
HPLC, GC, FT-IR and FT-NIR, titrations, and other
pharmacopoeial methods.
Dr Reto Theiß
Merck KGaA, Darmstadt, Germany
Dr. Reto Theiß started in 1997 at Temmler Pharma
in Marburg. In 1999 he became deputy Head of
Temmler’s Quality Control department. In 2002
he changed to Merck in Darmstadt serving as QP
responsible for releasing products of the generic branch for the
market. Since January 2005 his duties include the QA supervision
of solid dosage forms during the whole production chain.
Dr Thomas Storm
Novartis Pharma AG, Basel, Switzerland
Thomas Storm studied Chemistry and Physics,
PhD in Environmental Technology, TU Berlin.
Worked since 2001 as Head of Laboratory in
Analytical Development at Schering AG / Bayer
Schering Pharma AG, Berlin. Joined Novartis in 2008 as Head
of Laboratory in Inhalation Development and Technology.
Work areas included quality control of excipients, introduction
of novel excipients, supplier qualification, quality control for
development candidates, electronic raw data archival, HPLC,
HPLC/MS, CDS, and, recently, inhalation specific analytics.
Social Event
At the end of the first course 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.

Quality Control and Quality Assurance of Pharmaceutical Packaging Materials
6 – 7 May 2009, Vienna, Austria
Learning Goals
The focus of this GMP Education Course is on the presentation
of concrete tests for packaging materials, as
carried out in every incoming-goods laboratory of the
pharmaceutical quality control. Among these are sampling
and determining the necessary random sampling
sizes, the use of infrared spectroscopy, the control of dimensions
and the control of printed packaging materials,
including the GMP-compliant documentation of these
packaging control activities. The impact of the new requirements
of EU Annex 19 on packaging material reference
samples will also be discussed.
Background
There is a great number of regulatory requirements on
pharmaceutical packaging materials, in the pharmacopoeias,
the GMP regulations, in the FDA guidances, etc.
The pharmaceutical manufacturer has to guarantee that
only such packaging materials are used that are correctly
printed, in conformity with the specifications and in
compliance with the regulatory requirements.
The quality control unit is responsible for the control of
pharmaceutical packaging materials including the receipt,
identification, sampling, testing, and approval or
rejection of drug product containers and closures.
In order to determine the scope of the tests for the quality
control of pharmaceutical packaging materials, in
some countries the „Defect Evaluation Lists“ have proved
efficient. The responsibility for the tests lies now more
and more with the manufacturers of packaging materials.
However, as a precondition for this, additional QA
measures, like vendor qualification, supplier audit and
technical agreements, have to be taken.
It is the objective of this seminar to describe the GMP
requirements on packaging materials, the sampling of
packaging materials and the control of incoming packaging
materials comprehensively and to illustrate them with
the help of examples.
Target Group
This GMP Education Course on the testing of pharmaceutical
packaging materials is directed at employees in
pharmaceutical quality control departments who are responsible
for sampling, testing, approval and control of
primary and secondary packaging materials.
The Course is also intended for quality assurance personnel
as well as for staff of manufacturers and suppliers of
packaging materials.
Moderator
Dr Jörg Zürcher, Bayer Schering Pharma AG, Germany
Programme
Regulatory Requirements on Pharmaceutical Packaging
Materials
� Regulatory framework
� US Federal Register, Code of Federal Regulations (CFR)
� US Guidance for Industry: Container Closure Systems
� EC Guidance: Plastic Immediate Packaging Materials
� US Drug Master Files
� EC legislation, Eudralex, foodstuff regulations
Dr Mayk Kresse, Bayer Schering Pharma AG
Equipment Calibration and Qualification in Pharmaceutical
Packaging Control
� Principles of instrument qualification, calibration and
analytical method validation in the QC laboratory
� DQ, IQ, OQ, PQ
� Examples of instrument qualification in the QC packaging
laboratory
Dr Helmut Gaus, Rentschler Biotechnologie GmbH
Defect Evaluation Lists
� General principles and specific Defect Evaluation Lists
(DEL)
� Random Sampling Tables for qualitative and for
time-consuming, destructive and quantitative tests
� Acceptable Quality Level
� “Applied DEL” – LIMS-supported routine release testing
� Sample defects and their classification
Dr Mayk Kresse, Bayer Schering Pharma AG
WORKSHOP I
Examples of Defect Packaging Materials
The aim of this workshop is to discuss in small discussion
groups the evaluation of some defect packaging materials
that are presented. Are the defects of these packaging
materials critical or non-critical? Has the lot to be rejected
or can it still be used?
Participants will learn how to apply the general recommendations
of accepted and published Defect Evaluation
Lists for specific and individual packaging materials.
Moderator: Dr Mayk Kresse
Control of Dimensions
� Control of dimension for packaging materials
- Overview over systems/equipment
- Measuring screws, digital measuring slides, dial gauges
- Measuring microscope
- Contour projector
- Perthometer
� Requirements on measuring devices in daily use at
the incoming control for packaging materials:

- Monitoring and calibration of testing equipment
� Special applications
Dr Gerald Kindermann, F. Hoffmann-La Roche AG
Documentation of Packaging Control
� Regulatory background
� Set-up of specifi cations
� Testing procedures
� Documentation
Dr Jörg Zürcher, Bayer Schering Pharma AG
Infrared Spectroscopy for Packaging Materials
� Principle of the method
� Pharmacopoeial background
� Identity testing by IR
� Quantitative analysis by IR
� Method evaluation (benefi ts and limits)
Dr Jörg Zürcher, Bayer Schering Pharma AG
Testing of Extractables/Leachables
� Regulatory background
� Principles of Extractable and Leachable testing
� Potential Extractables of different Container Materials
� Routine Testing of Extractables
Dr. Jörg Zürcher, Bayer Schering Pharma AG
WORKSHOP II
Strategies for Reduced Testing
The aim of this workshop is to evaluate in small discussion
groups how the opportunities and requirements
of EU Annex 8 and 21 CFR Part 211.84 should be implemented
in the everyday practice of pharmaceutical
quality control departments for packaging materials.
Moderator: Dr Gerald Kindermann
Control of Printed Packaging Materials
� Control of incoming imprinted packaging materials
- Yes? How? What?
� Overview of imprinted packaging materials for pharmaceutical
operations
� Requirements on the performance of imprinted packaging
materials testing:
- Sampling plan, performance of sampling and control
of incoming packaging materials
- Certifi ed suppliers - a high-producing cooperation
- Experiences with the control of imprinted packaging
materials
Dr Gerald Kindermann, F. Hoffmann La Roche AG
Quality Testing of Packaging Materials:
Practical Examples
� Sampling tables, test procedures and acceptance criteria
for the incoming inspection of various packaging
materials, e.g.
- Bottles and caps, plastic fi lms and foils, glass, syringes
and carpules, rubber stoppers, tubes
Dr Helmut Gaus, Rentschler Biotechnologie GmbH
Reference Samples of Packaging Materials
� Requirements of EU-GMP Guide Annex 19
� Consequences for Packaging Materials
Dr Gerald Kindermann, F. Hoffmann La Roche AG
Social Event
On the evening of the fi rst course 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.
Speakers
Dr Helmut Gaus, Rentschler Biotechnologie
GmbH, Laupheim, Germany
Dr Gaus started at Merckle/ratiopharm, in
2001 he took over at Novartis-Generics, the
position of Qualifi ed Person and Head of
Quality Control. From 2003 to 2006 he was
Head of Quality Control at Vetter Pharma. Since 2006 he
is Qualifi ed Person and Vice President Quality Control at
Rentschler Biotechnologie. Within his various positions in
the pharmaceutical industry the incoming inspection of
packaging components was always part of his responsibility.
Dr Gerald Kindermann, F. Hoffmann-La Roche
AG, Basle, Switzerland
Dr. Kindermann joined Roche in 1996. From
2001 to 2003 he led the group for control of
incoming packaging materials at Roche
Kaiseraugst (galenical production). His area
of responsibility covered release analysis of packaging
materials, the technical control of all packaging materials,
and change control of specifi cations and analytical
methods. He then became Quality Manager for the
Supply Centre Kaiseraugst, and has been responsible for
the quality aspects of a SAP project at Roche within
Europe. 2008 he joined the Global Quality group at
Roche working on quality systems.
Dr Mayk Kresse, Bayer Schering Pharma AG,
Berlin, Germany
Dr Kresse joined the packaging department
of Schering in 1998. Main fi elds of work were
Quality Control, Quality Assurance Packaging
and Packaging Development. Since 2003 he
has been heading the packaging development team for
solid dosage forms within Pharmaceutical Development.
Main task is the development of state-of-the-art packaging
solutions in compliance with pharmaceutical, legal/
regulatory, technical and economical requirements.
Dr Jörg Zürcher, Bayer Schering Pharma AG,
Berlin, Germany
Dr Jörg Zürcher is responsible for the development
of containers and packaging materials
at Schering since 1990. He started as a
scientist with focus on immediate container
development for all dosage forms. Since 2002 he is
leading the group responsible for development of all
packaging components for liquid and parenteral dosage
forms.

Easy Registration
Reservation Form:
� CONCEPT HEIDELBERG
P.O. Box 10 17 64
69007 Heidelberg,
Germany
Quality Control of Raw Materials
Date
Monday, 4 May 2009, 9.00 h – 18.00 h
(Registration and coffee 8.30 h – 9.00 h)
Tuesday, 5 May 2009, 9.00 h – 16.30 h
Fees
EU GMP Inspectorates € 845.- per delegate plus VAT
ECA Members € 1,521.- per delegate plus VAT
APIC members € 1,605,- per delegate plus VAT (does
not include ECA membership)
Non-ECA Members € 1,690.- per delegate plus VAT
The conference fee is payable in advance after
receipt of invoice and includes conference documentation,
dinner on the first day, lunch on both
days and all refreshments. VAT is reclaimable.
Quality Control and Quality Assurance of
Pharmaceutical Packaging Materials
�
Date
Wednesday, 6 May 2009, 09.00 h - 18.30 h
(Registration and Coffee 8.30 h - 9.00 h)
Thursday, 7 May 2009, 08.30 h - 16.30 h
Fees
EU GMP Inspectorates € 845.- per delegate plus VAT
ECA Members € 1,521.- per delegate plus VAT
APIC members € 1,605,- per delegate plus VAT (does
not include ECA membership)
Non-ECA Members € 1,690.- per delegate plus VAT
The course fee is payable in advance after receipt
of invoice and includes conference documentation,
dinner on the first day, lunch on both
days and all refreshments. VAT is reclaimable.
If the bill-to-address deviates from the specification
to the right, please fill out here:
CONCEPT HEIDELBERG
P.O. Box 10 17 64
Fax +49 (0) 6221/84 44 34
69007 Heidelberg
Germany
Reservation Form:
+ 49 6221 84 44 34
Venue of both events
Renaissance Wien Hotel
Linke Wienzeile/Ullmannstr. 71
1150 Vienna, Austria
Phone + 43 / 1 89 102
Fax + 43 / 1 89 102 300
Do you want to save money?
Accommodation
CONCEPT has reserved a limited number of
rooms in the conference hotel. You will receive
a room reservation form when you have registered
for the event. Please use this form for your
room reservation or be sure to mention “VA
5944/5951 ECA Course” to receive the specially
negotiated rate for the duration of your stay.
Reservation should be made directly with the
hotel not later than 4 April 2009. Early reservation
is recommended.
Registration
e-mail: @ info@concept-heidelberg.de � Internet:
www.gmp-compliance.org
Via the attached reservation form, by e-mail or
by fax message. Or you register online at www.
gmp-compliance.org.
Conference language
The official conference language will be English.
Organisation and Contact
CONCEPT HEIDELBERG
P.O. Box 10 17 64
D-69007 Heidelberg, Germany
Phone +49 (0) 62 21/84 44-0
Fax +49 (0) 62 21/84 44 34
info@concept-heidelberg.de
www.concept-heidelberg.de
For questions regarding content:
Dr Günter Brendelberger (Operations
Director) at phone +49-62 21 / 84 44 40,
or per e-mail at
brendelberger@concept-heidelberg.de.
For questions regarding reservation, hotel,
organisation etc. (Quality Control of Raw
Materials):
Ms Marion Grimm (Organisation Manager) at
+49-62 21 / 84 44 18, or per e-mail at
grimm@concept-heidelberg.de.
For questions regarding reservation, hotel,
organisation etc. (Quality Control and Quality
Assurance of Pharmaceutical Packaging
Materials):
Ms Marion Weidemaier (Organisation Manager)
at phone +49-62 21 / 84 44 46, or per e-mail at
weidemaier@concept-heidelberg.de.
Reservation Form (Please complete in full)
Quality Control Compliance Week, 4-7 May 2009, Vienna Austria
� Quality Control of Raw Materials, 4-5 May 2009
� Quality Control and Quality Assurance of Pharmaceutical Packaging Materials, 6-7 May 2009
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General terms and conditions
If you cannot attend the conference you have two options:
1. We are happy to welcome a substitute colleague at any time.
2. If you have to cancel entirely we must charge the following processing fees: Cancellation
� until 2 weeks prior to the conference 10 %,
� until 1 weeks prior to the conference 50 %
� within 1 week prior to the conference 100 %.
CONCEPT HEIDELBERG reserves the right to change the materials, instructors, or speakers without
notice or to cancel an event. If the event must be cancelled, registrants will be notified as soon as
If you book the complete Quality Control
Compliance Week from 4 to 7 May 2009
you will save € 300,-
possible and will receive a full refund of fees paid. CONCEPT HEIDELBERG will not be responsible for
discount airfare penalties or other costs incurred due to a cancellation.
Terms of payment: Payable without deductions within 10 days after receipt of invoice.
Important: This is a binding registration and above fees are due in case of cancellation or non-appearance.
If you cannot take part, you have to inform us in writing. The cancellation fee will then
be calculated according to the point of time at which we receive your message. In case you do not
appear at the event without having informed us, you will have to pay the full registration fee, even if
you have not made the payment yet. Only after we have received your payment, you are entitled to
participate in the conference (receipt of payment will not be confirmed)!