Quality of Pharmaceutical Packaging Systems - European ...

ECA Certified Quality Control Manager Course*Participate in 2 Workshops:• Examples of Defect Packaging Materials• FMEA: Critical Parameters for a Suitable QualityControl System for Packaging MaterialsQuality of PharmaceuticalPackaging SystemsFrom Development to Routine Control13 – 14 March 2012, Berlin, GermanySPEAKERS:Dr Helmut GausRentschler BiotechnologieDr Mayk KresseBayer PharmaDr Jörg ZürcherBayer PharmaLEARNING GOALS:• Regulatory Requirements: EU and US• Packaging Related Topics of the CommonTechnical Document (CTD)• Specifications for Container ClosureSystems• Defect Evaluation Lists–– Random Sampling Tables–– Acceptable Quality Levels (AQL)• Quality Control–– Receipt, Identification, Sampling,Testing, Approval, and Rejection ofPackaging Materials• Strategies for Reduced Testing• Control of Printed Packaging Materials• Reference Samples of PackagingMaterials According to EU GMP GuideAnnex 19• Dimensional Checks: MeasurementEquipment and Application Ranges• Testing of Extractables / Leachables* This education course is recognised for the ECA GMP Certification Programme „Certified Quality Control Manager“. Please find details at www.gmp-certification.eu

Quality of Pharmaceutical Packaging Systems: From Development to Routine Control13 – 14 March 2012, Berlin, GermanyObjectivesThe focus of this GMP Education Course is on the developmentand routine control of pharmaceutical packagingsystems. Participants will learn how to develop pharmaceuticalpackaging materials systematically, and howto translate the requirements of the Common TechnicalDocument (CTD) to regulatory documents for packagingmaterials.The course will also focus on the testing of a variety ofdifferent packaging materials, as carried out in every incoming-goodslaboratory in quality control.This includes the setting of sound and scientific specificationsand Acceptable Quality Levels (AQLs), the controlof dimensions, and the control of printed packaging materials.The impact of EU Annex 19 on packaging material sampleswill also be discussed.BackgroundThere is a great number of regulatory requirements onpharmaceutical packaging materials, in the pharmacopoeias,the GMP regulations, in the FDA guidances, etc.Packaging materials also have to be described in the registrationprocess of a drug product according to the requirementsof the CTD.And the pharmaceutical manufacturer has to guaranteethat only such packaging materials are used that are correctlyprinted, in conformity with the specifications andin compliance with the regulatory requirements.The quality control unit is responsible for the control ofpharmaceutical packaging materials including the receipt,identification, sampling, testing, and approval orrejection of drug product containers and closures.In order to determine the scope of the tests for the qualitycontrol of pharmaceutical packaging materials, the„Defect Evaluation Lists“ have proved efficient. The responsibilityfor the tests lies now more and more with themanufacturers of packaging materials, while the pharmaceuticalindustry tries to reduce testing at the same time.However, as a precondition for this, additional QA measures,like supplier qualification, audits and supply agreements,have to be taken.Target AudienceThis GMP Education Course is directed at employeesworking in pharmaceutical research and development,regulatory affairs, quality control, incoming goods controlof packaging materials, and quality assurance departments.The Course is also intended for staff of manufacturersand suppliers of packaging materials.ProgrammeRegulatory Requirements applicable to PharmaceuticalPackaging Materials• Code of Federal Regulations (CFR)• US Guidance for Industry: Container Closure Systems• EC Guidance: Plastic Immediate Packaging Materials• European Foodstuff RegulationsDr Mayk KresseBayer Pharma AG, GermanyPackaging Related Topics of the Common TechnicalDocument (CTD)• CTD structure (packaging related)• Translation of CTD requirements to Technical RegulatoryDocuments (TRD)• Organisation of TRD• Templates• Best practice (blister and infusion bottle)Dr Jörg ZürcherBayer Pharma AG, GermanyDevelopment of Specifications for Container ClosureSystems• Transforming a wish-list into a target profile• Conversion of a target profile into a specification• Critical parameters / acceptance criteriaDr Jörg ZürcherBayer Pharma AG, GermanyDefect Evaluation Lists• Manufacturing of moulded and tubular glass containers• Concept of Defect Evaluation List• Special Defect Evaluation Lists: Containers made ofmoulded and tubular glassDr Mayk KresseBayer Pharma AG, GermanyWORKSHOP IExamples of Defect Packaging MaterialsThe aim of this workshop is to discuss in small discussiongroups the evaluation of some defectpackaging materials that arepresented. Are the defects of thesepackaging materials critical or noncritical?Has the lot to be rejectedor can it still be used? Participantswill learn how to apply the generalrecommendations of accepted and published DefectEvaluation Lists for specific and individual packagingmaterials.Moderator: Dr Mayk Kresse

Quality Control of Primary Packaging Material• What is a suitable QC system for Primary PackagingMaterials• Definition of critical parameters• Best practice in testing• AQL testing, scip lot• Must to have QA systems (i.e. OOS, complaints)• Sample management incl. reference samplesDr Helmut GausRentschler Biotechnologie GmbH, GermanySupplier Management• Supplier qualification and audits• Supply agreements and supplier qualification• Quality standards for suppliers• Cascade of Quality Control, reduced testing• Sampling PlansDr Helmut GausRentschler Biotechnologie GmbH, GermanyWORKSHOP IIRisk Management (Focus: FMEA)The aim of this workshop is to define in small discussiongroups the critical/major parameters to build up a suitablequality control system for your packaging materials.Focus will be on the practical application in a FMEA.The groups will evaluate• What, why, and where to test• Value of FMEA in the Quality Control concept forpackaging materials• Strategies for reduced testingModerator: Dr Helmut GausDimensional Checks in Packaging Development andQuality Control• Measurement equipment: overview• Application ranges• Practical examplesDr Mayk Kresse, Bayer Pharma AG, GermanyControl of Printed Packaging Materials• Legal requirements• Level of certification• Sample size & test procedures• Reference samples vs. retention samples (Annex 19)Dr Helmut GausRentschler Biotechnologie GmbH, GermanyTechnical Specifications• Scope & content• Concept (proposal)• Template and practical exampleDr Mayk KresseBayer Pharma AG, GermanyTesting of Extractables/Leachables• Regulatory Background• Principles of Extractable and Leachable testing• Potential Extractables of different Container MaterialsDr. Jörg ZürcherBayer Pharma AG, GermanyModeratorDr. Jörg ZürcherBayer Pharma AG, GermanySpeakersDr Helmut GausRentschler Biotechnologie GmbH, Laupheim,GermanyDr. Gaus started at Merckle/ratiopharm, in2001 he took over at Novartis-Generics, theposition of Qualified Person and Head of Quality Control.From 2003 to 2006 he was Head of Quality Controlat Vetter Pharma. Since 2006 he is Qualified Person andVice President Quality Control at Rentschler Biotechnologie.Within his various positions in the pharmaceuticalindustry the incoming inspection of packaging componentswas always part of his responsibility.Dr Mayk KresseBayer Pharma AG, Berlin, GermanyDr Kresse joined the packaging departmentof Bayer Pharma in 1998. Main fields of workwere Quality Control, Quality AssurancePackaging and Packaging Development. Since2003 he has been heading the packaging developmentteam for solid dosage forms within PharmaceuticalDevelopment. Main task is the development ofstate-of-the-art packaging solutions in compliance withpharmaceutical, legal/regulatory, technical and economicalrequirements.Dr Jörg ZürcherBayer Pharma AG, Berlin, GermanyDr Jörg Zürcher is responsible for the developmentof containers and packaging materialsat Bayer Pharma since 1990. He started asa scientist with focus on immediate containerdevelopment for all dosage forms. Since 2002he is leading the group responsible for development ofall packaging components for liquid and parenteral dosageforms.Social EventOn the evening of the first course day you are cordiallyinvited to a social event. This is an excellent opportunityto share your experiences with colleagues from othercompanies in a relaxed atmosphere.