wa/vers1/12012017This education course is recognised for the ECA GMP Certification Programme „Certified API Production Manager“. Please find details at www.gmp-certification.eu

Handling of Foreign Particles in APIs Preventive measures, analytical controls and incident management

SPEAKERS:

Nils Dickfeld Meliscout, Germany

Jörg GampferHovione, Portugal

Peter Mungenast Merck KGaA, Germany

Dirk OverrödderCilag, Switzerland

Luisa PauloHovione, Portugal

Jordi Ruiz-CombaliaSpain

HIGHLIGHTS:

� Key preventive measures to minimise foreign particles � Acceptance criteria for particles in APIs � Analytical control methods for particle detection � Good cleaning practices to minimise the presence of particles

� Particles in Packaging Materials � How to identify the source of insoluble matter � How to avoid the presence of foreign particles and insoluble matter – risk assessment and CAPAs

18-19 May 2017, Barcelona, Spain

Objectives

During this course all relevant aspects regarding the con-trol of particles in APIs will be discussed. You will learn

� How potential sources of insoluble matter can be identified

� Which acceptance criteria for particles can be applied � How good practices to minimise the presence of

particles in APIs can look like � What has to be considered regarding control of

particles during plant and equipment maintenance and cleaning

� How particles in Raw Materials and Packaging Materi-als can be minimised or avoided

Background

Visible particles, insoluble particles or matter or foreign particles in Active Pharmaceutical Ingredients (APIs) and related intermediates is a topic of great interest and im-portance to the pharmaceutical industry.

A number of inspectional observations from various Regulatory Authorities related to visible particles in Drug Products and APIs has risen considerable concern. Moreover inappropriate methods of investigation, con-trols and preventive and corrective actions were all sub-jects of citations by authorities and observations by API customers.

Particles have always been present in APIs but guidance from health authorities (EMA, FDA, others) or Pharma-copoeias (e.g. EP, USP) about particles in APIs is very limited. The APIC Guidance on Insoluble Matter and Foreign Particles in APIs is the only document so far providing guidance for a standard approach towards an appropriate control of foreign particles in APIs.

Target Audience

This course is designed for all persons involved in the manufacture of APIs. In particular, the seminar will be of interest to personnel from quality assurance, quality con-trol and production.

Social Event

In the evening 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 at-mosphere.

Programme

Particles and insoluble matter in API manufacturing: why is it a topic of great interest?

� Definition of particles � Types of particles � Possible reasons for the elevated presence of

visible particles � Hints in guidances on how to deal with visible

particles � Inspectional observations � Expectations of API manufacturers, API users, API

suppliers and supervisory authorities regarding visible particles in APIs

Analytical control methods for particle detection and identification

� General conditions: design of an appropriate sampling process

� Application of different inspection techniques: filter test, visual inspection etc.

� Metal detectors, metal separators � Weighing and/or visual inspection of pieces of

equipment � Periodic review of security sieves and/or filters

Incident management � Potential sources of insoluble matter � Root cause analysis – examples of investigation

techniques and aids � Risk assessment: topics to be considered during

the investigation/disposition decision

Handling of Foreign Particles in APIs

18-19 May 2017, Barcelona, Spain

Acceptance criteria for particles in APIs � Types of dosage forms and routes of administration � Typical limits for particle size seen via a filter test � Proposal for limits � Typical construction materials in API manufacturing

plants as source of particles � Effective cleaning procedures � Pretreatment of equipment/product contact utilities � Inspection of equipment before and after production � Cleaning after repairs � Essential written procedures covering maintenance

and cleaning procedures Environmental conditions during open handling in final stages of API manufac-turing

� Effective training of operators

How can routine cleaning procedures detect or mini-mise the presence of particles in API production

� Routine cleaning activities to reduce cross contamina-tion and particle contamination

� Pretreatment of the equipment train before use � Rinsing of the equipment to detect particles � Inspection of equipment before and after production � Cleaning after repairs � Cleaning of packaging materials (drums, IBCs)

Case Study: Automatic detection and removal of visible foreign particles in APIs

� Foreign particles removal in powders and granules � Types of foreign particles materials � Concept of automated foreign particles detection and

removal

Particles in Raw Materials and Packaging Materials � Potential particles in raw materials/packaging

materials � Standard checks by QC � Qualification of raw materials suppliers � Communication with suppliers

Speakers

Nils DickfeldMeliscoutNils Dickfeld studied Optical Technology and Image Processing. He has been working for PCE as development engineer and head-ed the department for Printing Verification.

In 2012 he founded Melibokus Startup Scout (Meliscout) focusing on image processing for the chemical and phar-maceutical industry.

Dr Jörg GampferHovione, Portugal

Peter Mungenast, Merck KGaA, DarmstadtPeter Mungenast studied Biology and Chemistry at the University in Karlsruhe. Then he worked in different functions for Merck KGaA. Since 1996 in the Quality As-

surance department responsible for cleaning validation, training and different projects.

Dirk OverrödderCilag, Schaffhausen. SwitzerlandDirk Overrödder joined Cilag AG in 1995 and was employed in various positions in R&D and Compliance. Since May 2014 he has been Head of QA Small Molecules (API

& Drug Product) at Janssen’s site in Schaff-hausen, Swit-zerland.

Luisa PauloHovione, PortugalLuisa is Compliance Director at Hovione and Chair of APIC’s Quality Metrics Task Force.

Dr Jordi Ruiz-CombaliaSpainDr Ruiz-Combalia has 30 years experience in the Active Pharmaceutical Ingredient In-dustry, where he has had different responsi-bilities. In his current position he has been

working as R&D Director. Since 1992, he is a member of the Organic Chemistry Expert Group of the Real Farma-copea Española. Since 1994, he is member of the Groups of Experts of the European Pharmacopoeia, currently chairman of Group 11S and collaborates with the APIC (Active Pharmaceutical Ingredients Committee) in the GMP Working Group.

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Reservation Form:+ 49 6221 84 44 34 @ e-mail:

info@concept-heidelberg.de Internet:www.gmp-compliance.org

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Date

Thursday, 18 May 2017, 10.00 – 18.00 h(Registration and coffee 9.30 – 10.00 h)Friday, 19 May 2017, 9.00 – 13.00 h

Venue

Barceló Sants HotelPlaça dels Països Catalans, s/n08014 Barcelona, SpainPhone +34 (93) 503 53 00Fax +34 (93) 490 60 45

Fees (per delegate plus VAT)

ECA Members € 1,590APIC Members € 1,690Non-ECA Members € 1,790EU GMP Inspectorates € 895The conference fee is payable in advance after receipt of invoice and includes conference docu-mentation, dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable.

Accommodation

CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.

Registration

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

ECA has entrusted Concept Heidelberg with the organisation of this event.

CONCEPT HEIDELBERGP.O. Box 10 17 64 69007 Heidelberg, GermanyPhone +49-62 21/84 44-0Fax +49-62 21/84 44 84info@concept-heidelberg.dewww.concept-heidelberg.de

For questions regarding content:Dr Gerhard Becker (Operations Director) at +49-62 21/84 44 65, or per e-mail at becker@concept-heidelberg.de.

For questions regarding reservation, hotel, organisation etc.:Ms Katja Kramer (Organisation Manager) at +49-62 21/84 44 16, or per e-mail at kramer@concept-heidelberg.de

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