Transcript European and International Standards

European and International
Certification for Pharmaceutical
Packaging Materials
The development of an International
Standard for Pharmaceutical Packaging
Materials
Tony Harper
Principal UK Expert to ISO/TC 76 WG 6
31/01/2006
© 2006
1
European and International
Standards
UK
France
Germany
Sweden
ISO
31/01/2006
© 2006
2
European Certification
Certipharm – France
QAPP (Quality Association for
Pharmaceutical Packaging) – Germany
PQG (Pharmaceutical Quality Group) – UK
Sweden
International Certification Bodies
AJA, BSI, BVQI, DNV, LRQA, NQA, NSAI, SGS-Y, TUV &
more to come?
31/01/2006
© 2006
3
European Certification
Standards
Auditors
Training
Certification
Co-operation
Recognition
Harmonisation.
31/01/2006
© 2006
4
European Certification
France, Germany and UK
Meetings
Comparison of standards
Comparison of auditing
Witnessed audits, two in each country planned
Evaluation
Process for recognition to be defined and then
work towards harmonisation of standards, auditor
training, auditing and certification
Other interested parties & countries welcome!
Please volunteer – particularly to work on ISO
15378!!
31/01/2006
© 2006
5
Auditor Certification
Standards in Europe are similar
Standard of auditing varies
Need to harmonise
Use PQG Auditor Scheme as a basis?
Extend to Europe??
Extend Worldwide???
31/01/2006
© 2006
6
UK Standards
Codes of Practice – 1990 - 2001
P00020 Raw Materials
P00021 Printed Components
P00022 Contact Packaging
PS 9000:2001 - >>>>>
Contact & Packaging in one Standard
PS 9004:2004
Guide to the GMP requirements of PS 9000.
31/01/2006
© 2006
7
French Standards
Certipharm
GMP requirements for suppliers
Reading Guide
French translation of PS 9000!
31/01/2006
© 2006
8
German Standards
Quality Association Pharmaceutical
Packaging – QAPP
Membership of QAPP mandatory for
Certification
Secondary Packaging Material Suppliers
only
QAPP GMP Standard
Good level of validation.
31/01/2006
© 2006
9
Sweden
PS 9000
Translated into Swedish
• Cerbo – Primary (Trollhattan) & Secondary
Packaging Materials (Gothenburg)
• Nord-Emballage & Zata – Secondary
Packaging Materials only (2 sites in Ystad).
31/01/2006
© 2006
10
International Standards
ISO 15378:2006
Includes all of ISO 9001:2000
Additional requirements for packaging
materials
2006 version – primary packaging only
Mandatory Annex for Printed Components
Guidance Annexes for Risk management
and Validation.
31/01/2006
© 2006
11
Development process
Initial German ‘ad-hoc’ meeting, 2002
Ad-hoc group within ISO/TC 76, 2003
Initial drafts, limited circulation, 2003-4
UK involvement, suggested significant
changes, 2003-2005
Ad-hoc group became ISO/TC 76 WG 6
NWI – ISO New Work Item: ISO 15378.
31/01/2006
© 2006
12
ISO/TC 76
“Infusion, transfusion and medical
equipment”!
Not the ideal ‘home’
Limited contacts (internationally)
Drafts did not reach the people who could
comment
Input limited to the ‘few’
Composition of WG 6 was unbalanced.
31/01/2006
© 2006
13
UK Input
UK Team
Tony Harper
Roy Evans
Jill Jenkins
Steve Taylor
Ashok Chand
David Abraham
Antoinette Devine
Bill Hewlett
Mike Shorten
John Turner ….. and others - maybe some of you!
31/01/2006
© 2006
14
What did UK do!
Ensured a more consistent approach
Removed many errors
Identified omissions
Made significant additions based on PS
9000
Turned the draft into an auditable
document
Assisted the Secretariat with editing.
31/01/2006
© 2006
15
The result!
31/01/2006
© 2006
16
31/01/2006
© 2006
17
31/01/2006
© 2006
18
ISO 15378 – Key Requirements
4.2.4
5.5.3
6.2.2.1
6.4
6.5
7.2.3
7.4.1
7.5
8.2.4.1
8.3
31/01/2006
Records
Internal communication
GMP Training
Work environment
Maintenance
Customer communication
Purchasing
Cleanliness & contamination control
OOS (Out of Specification)
Non-conforming product.
© 2006
19
The (2) key annexes
Annex B – Validation
Annex 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.
31/01/2006
© 2006
20
ISO 15378:2006
Publication expected 31/03/06
Certification will follow
Glass companies expected to lead the
way – Internationally
‘Others’ will follow
What will PQG do to promote and
encourage?
31/01/2006
© 2006
21
What next?
Extend the scope for Secondary
Packaging Materials
Produce a supporting Guidance
document
And how do these fit in? >>>>>>>>>>>
31/01/2006
© 2006
22
ISO 9001
Scope
GMP (GxP)
Principles
Detail &
Auditor
competence
GMP
Guidance
ISO 9001 + GMP
=
ISO 15378
ISO 9000
Primary
Packaging
materials
Inhalation
Any questions please?
[email protected]
31/01/2006
© 2006
25