31/01/2006© 20061 european and international certification for pharmaceutical packaging materials...
TRANSCRIPT
![Page 1: 31/01/2006© 20061 European and International Certification for Pharmaceutical Packaging Materials The development of an International Standard for Pharmaceutical](https://reader036.vdocuments.site/reader036/viewer/2022062401/56649d0c5503460f949dfd2c/html5/thumbnails/1.jpg)
31/01/2006 © 2006 1
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
![Page 2: 31/01/2006© 20061 European and International Certification for Pharmaceutical Packaging Materials The development of an International Standard for Pharmaceutical](https://reader036.vdocuments.site/reader036/viewer/2022062401/56649d0c5503460f949dfd2c/html5/thumbnails/2.jpg)
31/01/2006 © 2006 2
European and International Standards
UKFranceGermanySweden
ISO
![Page 3: 31/01/2006© 20061 European and International Certification for Pharmaceutical Packaging Materials The development of an International Standard for Pharmaceutical](https://reader036.vdocuments.site/reader036/viewer/2022062401/56649d0c5503460f949dfd2c/html5/thumbnails/3.jpg)
31/01/2006 © 2006 3
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?
![Page 4: 31/01/2006© 20061 European and International Certification for Pharmaceutical Packaging Materials The development of an International Standard for Pharmaceutical](https://reader036.vdocuments.site/reader036/viewer/2022062401/56649d0c5503460f949dfd2c/html5/thumbnails/4.jpg)
31/01/2006 © 2006 4
European Certification
StandardsAuditorsTrainingCertificationCo-operationRecognitionHarmonisation.
![Page 5: 31/01/2006© 20061 European and International Certification for Pharmaceutical Packaging Materials The development of an International Standard for Pharmaceutical](https://reader036.vdocuments.site/reader036/viewer/2022062401/56649d0c5503460f949dfd2c/html5/thumbnails/5.jpg)
31/01/2006 © 2006 5
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!!
![Page 6: 31/01/2006© 20061 European and International Certification for Pharmaceutical Packaging Materials The development of an International Standard for Pharmaceutical](https://reader036.vdocuments.site/reader036/viewer/2022062401/56649d0c5503460f949dfd2c/html5/thumbnails/6.jpg)
31/01/2006 © 2006 6
Auditor Certification
Standards in Europe are similarStandard of auditing variesNeed to harmoniseUse PQG Auditor Scheme as a basis?
Extend to Europe??Extend Worldwide???
![Page 7: 31/01/2006© 20061 European and International Certification for Pharmaceutical Packaging Materials The development of an International Standard for Pharmaceutical](https://reader036.vdocuments.site/reader036/viewer/2022062401/56649d0c5503460f949dfd2c/html5/thumbnails/7.jpg)
31/01/2006 © 2006 7
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.
![Page 8: 31/01/2006© 20061 European and International Certification for Pharmaceutical Packaging Materials The development of an International Standard for Pharmaceutical](https://reader036.vdocuments.site/reader036/viewer/2022062401/56649d0c5503460f949dfd2c/html5/thumbnails/8.jpg)
31/01/2006 © 2006 8
French Standards
CertipharmGMP requirements for suppliersReading GuideFrench translation of PS 9000!
![Page 9: 31/01/2006© 20061 European and International Certification for Pharmaceutical Packaging Materials The development of an International Standard for Pharmaceutical](https://reader036.vdocuments.site/reader036/viewer/2022062401/56649d0c5503460f949dfd2c/html5/thumbnails/9.jpg)
31/01/2006 © 2006 9
German Standards
Quality Association Pharmaceutical Packaging – QAPP
Membership of QAPP mandatory for CertificationSecondary Packaging Material Suppliers onlyQAPP GMP StandardGood level of validation.
![Page 10: 31/01/2006© 20061 European and International Certification for Pharmaceutical Packaging Materials The development of an International Standard for Pharmaceutical](https://reader036.vdocuments.site/reader036/viewer/2022062401/56649d0c5503460f949dfd2c/html5/thumbnails/10.jpg)
31/01/2006 © 2006 10
Sweden
PS 9000Translated into Swedish• Cerbo – Primary (Trollhattan) &
Secondary Packaging Materials (Gothenburg)
• Nord-Emballage & Zata – Secondary Packaging Materials only (2 sites in Ystad).
![Page 11: 31/01/2006© 20061 European and International Certification for Pharmaceutical Packaging Materials The development of an International Standard for Pharmaceutical](https://reader036.vdocuments.site/reader036/viewer/2022062401/56649d0c5503460f949dfd2c/html5/thumbnails/11.jpg)
31/01/2006 © 2006 11
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.
![Page 12: 31/01/2006© 20061 European and International Certification for Pharmaceutical Packaging Materials The development of an International Standard for Pharmaceutical](https://reader036.vdocuments.site/reader036/viewer/2022062401/56649d0c5503460f949dfd2c/html5/thumbnails/12.jpg)
31/01/2006 © 2006 12
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.
![Page 13: 31/01/2006© 20061 European and International Certification for Pharmaceutical Packaging Materials The development of an International Standard for Pharmaceutical](https://reader036.vdocuments.site/reader036/viewer/2022062401/56649d0c5503460f949dfd2c/html5/thumbnails/13.jpg)
31/01/2006 © 2006 13
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.
![Page 14: 31/01/2006© 20061 European and International Certification for Pharmaceutical Packaging Materials The development of an International Standard for Pharmaceutical](https://reader036.vdocuments.site/reader036/viewer/2022062401/56649d0c5503460f949dfd2c/html5/thumbnails/14.jpg)
31/01/2006 © 2006 14
UK InputUK Team
Tony HarperRoy EvansJill JenkinsSteve TaylorAshok ChandDavid AbrahamAntoinette DevineBill HewlettMike ShortenJohn Turner ….. and others - maybe some of you!
![Page 15: 31/01/2006© 20061 European and International Certification for Pharmaceutical Packaging Materials The development of an International Standard for Pharmaceutical](https://reader036.vdocuments.site/reader036/viewer/2022062401/56649d0c5503460f949dfd2c/html5/thumbnails/15.jpg)
31/01/2006 © 2006 15
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.
![Page 16: 31/01/2006© 20061 European and International Certification for Pharmaceutical Packaging Materials The development of an International Standard for Pharmaceutical](https://reader036.vdocuments.site/reader036/viewer/2022062401/56649d0c5503460f949dfd2c/html5/thumbnails/16.jpg)
31/01/2006 © 2006 16
The result!
![Page 17: 31/01/2006© 20061 European and International Certification for Pharmaceutical Packaging Materials The development of an International Standard for Pharmaceutical](https://reader036.vdocuments.site/reader036/viewer/2022062401/56649d0c5503460f949dfd2c/html5/thumbnails/17.jpg)
31/01/2006 © 2006 17
![Page 18: 31/01/2006© 20061 European and International Certification for Pharmaceutical Packaging Materials The development of an International Standard for Pharmaceutical](https://reader036.vdocuments.site/reader036/viewer/2022062401/56649d0c5503460f949dfd2c/html5/thumbnails/18.jpg)
31/01/2006 © 2006 18
![Page 19: 31/01/2006© 20061 European and International Certification for Pharmaceutical Packaging Materials The development of an International Standard for Pharmaceutical](https://reader036.vdocuments.site/reader036/viewer/2022062401/56649d0c5503460f949dfd2c/html5/thumbnails/19.jpg)
31/01/2006 © 2006 19
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.
![Page 20: 31/01/2006© 20061 European and International Certification for Pharmaceutical Packaging Materials The development of an International Standard for Pharmaceutical](https://reader036.vdocuments.site/reader036/viewer/2022062401/56649d0c5503460f949dfd2c/html5/thumbnails/20.jpg)
31/01/2006 © 2006 20
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.
![Page 21: 31/01/2006© 20061 European and International Certification for Pharmaceutical Packaging Materials The development of an International Standard for Pharmaceutical](https://reader036.vdocuments.site/reader036/viewer/2022062401/56649d0c5503460f949dfd2c/html5/thumbnails/21.jpg)
31/01/2006 © 2006 21
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?
![Page 22: 31/01/2006© 20061 European and International Certification for Pharmaceutical Packaging Materials The development of an International Standard for Pharmaceutical](https://reader036.vdocuments.site/reader036/viewer/2022062401/56649d0c5503460f949dfd2c/html5/thumbnails/22.jpg)
31/01/2006 © 2006 22
What next?
Extend the scope for Secondary Packaging MaterialsProduce a supporting Guidance document
And how do these fit in? >>>>>>>>>>>
![Page 23: 31/01/2006© 20061 European and International Certification for Pharmaceutical Packaging Materials The development of an International Standard for Pharmaceutical](https://reader036.vdocuments.site/reader036/viewer/2022062401/56649d0c5503460f949dfd2c/html5/thumbnails/23.jpg)
Scope
Detail & Auditor competence
ISO 9001
GMP (GxP)
Principles
GMP
Guidance
ISO 9001 + GMP =
ISO 15378
![Page 24: 31/01/2006© 20061 European and International Certification for Pharmaceutical Packaging Materials The development of an International Standard for Pharmaceutical](https://reader036.vdocuments.site/reader036/viewer/2022062401/56649d0c5503460f949dfd2c/html5/thumbnails/24.jpg)
Q7a
A
P
I
s
I
S
O
1
5
3
7
8
PS
9000
G
M
P
E
x
c
i
p
i
e
n
t
s
IP
AC
-R
SPrimary
Packaging materials
ISO 9000
Inhalation