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European and International Certification for

Pharmaceutical Packaging Materials

The development of an International Standard for Pharmaceutical

Packaging MaterialsTony Harper

Principal UK Expert to ISO/TC 76 WG 6

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European and International Standards

UKFranceGermanySweden

ISO

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European Certification

Certipharm – FranceQAPP (Quality Association for Pharmaceutical Packaging) – GermanyPQG (Pharmaceutical Quality Group) – UKSweden

International Certification BodiesAJA, BSI, BVQI, DNV, LRQA, NQA, NSAI, SGS-Y, TUV & more to come?

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European Certification

StandardsAuditorsTrainingCertificationCo-operationRecognitionHarmonisation.

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European CertificationFrance, Germany and UK

MeetingsComparison of standardsComparison of auditingWitnessed audits, two in each country plannedEvaluationProcess for recognition to be defined and then work towards harmonisation of standards, auditor training, auditing and certificationOther interested parties & countries welcome!Please volunteer – particularly to work on ISO 15378!!

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Auditor Certification

Standards in Europe are similarStandard of auditing variesNeed to harmoniseUse PQG Auditor Scheme as a basis?

Extend to Europe??Extend Worldwide???

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UK Standards

Codes of Practice – 1990 - 2001P00020 Raw MaterialsP00021 Printed ComponentsP00022 Contact Packaging

PS 9000:2001 - >>>>>Contact & Packaging in one Standard

PS 9004:2004Guide to the GMP requirements of PS 9000.

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French Standards

CertipharmGMP requirements for suppliersReading GuideFrench translation of PS 9000!

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German Standards

Quality Association Pharmaceutical Packaging – QAPP

Membership of QAPP mandatory for CertificationSecondary Packaging Material Suppliers onlyQAPP GMP StandardGood level of validation.

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Sweden

PS 9000Translated into Swedish• Cerbo – Primary (Trollhattan) &

Secondary Packaging Materials (Gothenburg)

• Nord-Emballage & Zata – Secondary Packaging Materials only (2 sites in Ystad).

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International Standards

ISO 15378:2006Includes all of ISO 9001:2000Additional requirements for packaging materials2006 version – primary packaging onlyMandatory Annex for Printed ComponentsGuidance Annexes for Risk management and Validation.

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Development process

Initial German ‘ad-hoc’ meeting, 2002Ad-hoc group within ISO/TC 76, 2003Initial drafts, limited circulation, 2003-4UK involvement, suggested significant changes, 2003-2005Ad-hoc group became ISO/TC 76 WG 6NWI – ISO New Work Item: ISO 15378.

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ISO/TC 76

“Infusion, transfusion and medical equipment”!

Not the ideal ‘home’Limited contacts (internationally)Drafts did not reach the people who could commentInput limited to the ‘few’Composition of WG 6 was unbalanced.

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UK InputUK Team

Tony HarperRoy EvansJill JenkinsSteve TaylorAshok ChandDavid AbrahamAntoinette DevineBill HewlettMike ShortenJohn Turner ….. and others - maybe some of you!

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What did UK do!Ensured a more consistent approachRemoved many errorsIdentified omissionsMade significant additions based on PS 9000Turned the draft into an auditable documentAssisted the Secretariat with editing.

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The result!

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ISO 15378 – Key Requirements4.2.4 Records

5.5.3 Internal communication6.2.2.1 GMP Training6.4 Work environment6.5 Maintenance7.2.3 Customer communication7.4.1 Purchasing7.5 Cleanliness & contamination control8.2.4.1 OOS (Out of Specification)8.3 Non-conforming product.

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The (2) key annexesAnnex B – ValidationAnnex C – Risk Management

These two annexes although ‘Normative’, i.e. guidance, are probably the most significant additions to PS 9000 and were developed by an International team.

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ISO 15378:2006

Publication expected 31/03/06Certification will followGlass companies expected to lead the way – Internationally‘Others’ will followWhat will PQG do to promote and encourage?

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What next?

Extend the scope for Secondary Packaging MaterialsProduce a supporting Guidance document

And how do these fit in? >>>>>>>>>>>

Scope

Detail & Auditor competence

ISO 9001

GMP (GxP)

Principles

GMP

Guidance

ISO 9001 + GMP =

ISO 15378

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Inhalation

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Any questions please?

TonyHarper@aol.com