International Pharmaceutical Supplier GMP’s – An Update
February 7th 2006
ISO 15378 : 2005 with PS 9000ISO 15378 : 2005 with PS 9000
The Next StepThe Next Step
ISO 15378
Pharmaceutical Packaging Materials Pharmaceutical Packaging Materials HistoryHistory
PS 9000 - UK Industry 2000
ISO 15378 - International 2006
PS 9004 - UK Industry 2004
Code(s) of Practice - UK Industry 1995
Code(s) of Practice - UK Industry 1990
AQL’s - Company (BS 6001)
Audits - Company
Quality Visits - Company
Standards - Company
Specifications - Company and National
Standards ComparisonStandards Comparison
ISO 15378 : 2006
Versus
PS 9000 : 2000
(And PS 9004 : 2004)
ISO 15378 & PS 9000 ComparisonISO 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 ComparisonISO 15378 & PS 9000 Comparison
ISO 15378 PS 9000
GMP Focus
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) 2. PS 9000
Codes of Practice (1990 / 1995)
ISO 15378 & PS 9000 Comparison ISO 15378 & PS 9000 Comparison
Print RequirementsPrint Requirements
ISO 15378 PS 9000
Annex A (4 pages) Note
i. Excludes Secondary Materials
ii. Precludes Gang Printing
Parts 10 – 13 (11 pages)
Note
i. Precludes Gang Printing
ISO 15378 & PS 9000 ComparisonISO 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 ComparisonISO 15378 & PS 9000 ComparisonRequirementsRequirements
Requirements ISO 15378 PS 9000
New GMP’s i. 32 + Sub Clauses ii. 1 Normative Annex
iii. 2 Informative
Annexes
i. 24 + Sub Clauses ii. Print section 9-11
iii. 1 Normative Annex
iv. 4 Informative Annexes
SOP’s 17 13
Records 39 9
ISO 15378 & PS 9000 Comparison ISO 15378 & PS 9000 Comparison FocusFocus
ISO 15378 PS 9000
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)
i. Product Security ii. Preventing Cross
contamination
ISO 15378 & PS 9000 Comparison ISO 15378 & PS 9000 Comparison Definitions Definitions
ISO 9001 : 2000 ISO 15378 PS 9000
Only One Definition (but applies to ISO 9000 Details)
i. *Uses ISO 9001 : 2000 ii. 66 New Definitions
* Modified to Revise Supplier Subcontractor
i. Uses ISO 9001 : 2000 ii. 37 New Definitions
ISO 15378 & PS 9000 Comparison ISO 15378 & PS 9000 Comparison ReferencesReferences
ISO 9001 : 2000 ISO 15378 PS 9000
18
i. As ISO 9001 ii. 27 New References
e.g.
Code of Federal Regulations
ISO 13485 : 2003
(Medical Devices QMS)
i. As ISO 9001 ii. 27 New References
e.g.
BS 6001 : 1996 (Sampling Procedures...)
Medicines Act 1968 / 1971 MCA (MHRA) Website
ISO 15378 & PS 9000 ComparisonISO 15378 & PS 9000 ComparisonMarket FocusMarket 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 ISO 15378 & PS 9000 Comparison Why / How Guidance Why / How Guidance
ISO 15378 PS 9000 PS 9004
No Guidance / Background
Some Guidance / Background
e.g. see 7.3.2
Full PS 9000 Why / How Guidance to:
i. Aid Suppliers ii. Aid Staff Training iii. Aid Pharma / Supplier
Standards Harmonisation
ISO 15378 & PS 9000 Comparison ISO 15378 & PS 9000 Comparison Ease of Use Ease of Use
ISO 15378 PS 9000 PS 9004
i. More Prescriptive /
Formal (Written as ISO Quality Standard by Committee)
ii. 3 Pages of Contents iii. 3 Pages of Key Word
Index iv. 3 Annexes (20 pages)
i. More Descriptive (Written for Suppliers)
ii. 3 Pages of Contents iii. 10 Pages of Clause
Reference Comparison, i.e. ISO 9001 / ISO 9004 / PS 9000
iv. 5 Annexes v. Supplier Certification
Scheme
i. Descriptive Supplement
to PS 9000 ii. 2 Pages of Contents
iii. 18 Pages of Process Schematics
iv. 10 pages of Training
Support
v. 40 Pages of Process Clarifications
vi. 19 Pages of Key
Concept Explanations
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
ISO 15378 & PS 9000 ComparisonISO 15378 & PS 9000 ComparisonConclusionConclusion