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International Pharmaceutical Supplier
GMP’s – An Update
February 7th 2006
ISO 15378 : 2005 with PS 9000
The Next Step
ISO 15378
Pharmaceutical Packaging Materials
History
ISO 15378
- International 2006
PS 9004
- UK Industry 2004
PS 9000
- UK Industry 2000
Code(s) of Practice - UK Industry 1995
Code(s) of Practice - UK Industry 1990
Audits
AQL’s
Standards
Quality Visits
Specifications
- Company
- Company (BS 6001)
- Company
- Company
- Company and National
Standards Comparison
ISO 15378 : 2006
Versus
PS 9000 : 2000
(And PS 9004 : 2004)
ISO 15378 & PS 9000 Comparison
ISO 15378
GMP Based on ISO 9001 : 2000 QMS
PS 9000
GMP Based on ISO 9001 : 2000 QMS
(Linked to ISO 9004 : 2000)
PS 9004
Guide to the GMP Requirements of
PS 9000
ISO 15378 & PS 9000 Comparison
ISO 15378
GMP Focus
PS 9000
Primary Packaging
Materials
Primary and
Secondary Packaging
Materials
QMS 1
ISO 9001 : 2000
ISO 9001 : 2000
QMS 2
Incorporates
ISO 9004 : 2000
Principles
Clauses Compared
with
ISO 9004 : 2004
Requirements
1. ISO 15478 : 2003
(Medical Devices)
Codes of Practice
(1990 / 1995)
2. PS 9000
ISO 15378 & PS 9000 Comparison
Print Requirements
ISO 15378
PS 9000
Annex A (4 pages)
Parts 10 – 13 (11 pages)
Note
Note
i.
Excludes Secondary
Materials
ii.
Precludes Gang Printing
i.
Precludes Gang Printing
ISO 15378 & PS 9000 Comparison
ISO 15378
PS 9000
Application
Standard for
Design, Manufacture
and Supply of Primary
Packaging Materials
For Medicinal Products
Supply of Packaging
Materials to the
Pharmaceutical Industry
Applicable to
Supplier Certification
Supplier Certification
Infrastructure
ISO Quality
Management System
ISO QMS &
Pharmaceutical Quality
Group for:
i. Auditor Training
ii. Supplier
Certification /
Registration
ISO 15378 & PS 9000 Comparison
Requirements
Requirements
New GMP’s
ISO 15378
PS 9000
i.
32 + Sub Clauses
i. 24 + Sub Clauses
ii.
1 Normative Annex
ii. Print section 9-11
iii. 2 Informative
Annexes
iii. 1 Normative Annex
iv. 4 Informative
Annexes
SOP’s
17
13
Records
39
9
ISO 15378 & PS 9000 Comparison
Focus
ISO 15378
Extra GMP
Focus on
i.
Corrective Actions
ii. Preventive Actions
iii. Continual Improvement
iv. TSE Risks
v. Risk Management
(Annex C – 7 pages)
vi. Validation
(Annex B – 8 pages)
PS 9000
i.
Product Security
ii. Preventing Cross
contamination
ISO 15378 & PS 9000 Comparison
Definitions
ISO 9001 : 2000
Only One
Definition
(but applies to
ISO 9000 Details)
ISO 15378
PS 9000
i.
*Uses ISO 9001 : 2000
i.
ii.
66 New Definitions
ii. 37 New Definitions
* Modified to Revise
Supplier
Subcontractor
Uses ISO 9001 : 2000
ISO 15378 & PS 9000 Comparison
References
ISO 9001 : 2000
18
ISO 15378
i.
As ISO 9001
PS 9000
i.
As ISO 9001
ii. 27 New References
e.g.
ii. 27 New References
e.g.
 Code of Federal
Regulations
 BS 6001 : 1996
(Sampling Procedures...)
 ISO 13485 : 2003
(Medical Devices QMS)
 Medicines Act 1968 / 1971
 MCA (MHRA) Website
ISO 15378 & PS 9000 Comparison
Market Focus
ISO 15378
PS 9000
Produced
by
International Team
UK Team
Produced
For
International Market
European Market
(Suppliers and Pharma
Industry)
ISO 15378 & PS 9000 Comparison
Why / How Guidance
ISO 15378
PS 9000
PS 9004
No Guidance /
Background
Some Guidance /
Background
Full PS 9000 Why / How
Guidance to:
e.g. see 7.3.2
i. Aid Suppliers
ii. Aid Staff Training
iii. Aid Pharma / Supplier
Standards Harmonisation
ISO 15378 & PS 9000 Comparison
Ease of Use
ISO 15378
i.
More Prescriptive /
Formal
(Written as ISO
Quality Standard by
Committee)
ii. 3 Pages of Contents
iii. 3 Pages of Key Word
Index
PS 9000
i.
More Descriptive
(Written for Suppliers)
PS 9004
i.
Descriptive Supplement
to PS 9000
ii. 3 Pages of Contents
ii. 2 Pages of Contents
iii. 10 Pages of Clause
Reference Comparison,
i.e. ISO 9001 / ISO 9004
/ PS 9000
iii. 18 Pages of Process
Schematics
iv. 5 Annexes
iv. 10 pages of Training
Support
v.
v.
iv. 3 Annexes (20 pages)
Supplier Certification
Scheme
40 Pages of Process
Clarifications
vi. 19 Pages of Key
Concept Explanations
ISO 15378 & PS 9000 Comparison
Conclusion
ISO 15378 : 2006
The next Quality Step for Pharma Materials
An International Standard
For Primary Materials ONLY
Uses ISO 9001 : 2000 QMS
More Formal / Demanding the PS 9000
More GMP Requirements
Creates Harmony between Suppliers and
Customers
But PS 9000 continues for Secondary Materials