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