2015 postnl gdp masterclass antwerp - presentation by nick pople (pauwels consulting)

GDP AUDITS

WHAT TO EXPECT

HOW TO PREPARE

OBLIGATIONS AND REGULATIONS

BEST PRACTICES AND INDUSTRY INSIGHTS

Nick POPLE

GDP Expert

Pauwels Consulting

www.pauwelsconsulting.com

OVERVIEW

Brief introduction:

My background in the GDP industry

Contents of this presentation:

GDP: why, how, how not

Goals of this presentation:

Share GDP insights from an auditor’s point of view

Share GDP insights from an operator’s point of view

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MY HISTORY WITH EU GDP

First GDP regulations drafted in the 1980’s

Initial focus

My involvement in its evolution

Current status

Pharmaceutical products

CD’s Controlled drugs

Clinical trials

Patient name only

Medical devices

Veterinary products

Cosmetics

Dentistry

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OVER THE YEARS I HAVE CARRIED OUT

Regulatory audits

Manufacturer audits

External audits

Internal audits

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IN THIS PRESENTATION I WILL COVER

What to expect from an audit

How to prepare for an audit

How to approach an audit

What regulations to follow

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AND I WILL SHARE

Industry insights

Best practices

Do’s (examples)

Don’ts (examples)

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“AND TO KICK OFF”

Regulatory audit

Manufacturer audit

External audit

Internal audit

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FOCUS ISO 9001: GDP

Business Processes & Management Yes No

Customer Requirements Yes No

Product & Process Assurance Partly Yes

Mandatory for Pharma/Veterinary No Yes

Recognition by Regulatory Authorities No Yes

Compliance to Product Standards Partly Yes

Continuous Improvement Yes No

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HOW TO PREPARE

Focus Major Critical Minor

Cleaning/Housekeeping

NC & CAPA Management

Pest Control

Temperature Monitoring & Mapping

TMS Process & Validation

Documentation

Order Management, Shipping & Cross-

docking

Damaged/Rejected Products

Training

Internal Audits

Compliant Handling

Vendor Management

Change Management

Personnel Management

Management Review

Fleet Maintenance

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Open and Honest

Understand the Type of Audit

Except Criticism Constructively

Do not Hide Behind Company Policies

Do not Offer Lunch Off Site

OBLIGATIONS

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Treat the Audit as an Opportunity to Maintain Compliance

Audits will be part of new business tender qualification

OBLIGATIONS

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OBLIGATIONS

Standards of Good Distribution Practice are applied to

ensure that the high level of product quality is achieved

and maintained throughout the distribution network

WHY GDP?

To facilitate free movement of medicinal products within

the European Community

To exercise control over the distribution chain of

medicinal products from manufacturing or import into

the EC to supply to the public

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BEST PRACTICES AND INDUSTRY INSIGHTS

Evolution of GMP/GDP - “Trust Me!” Cola 1906 contains cocaine

Sulphanilamide 938 100s died

Thalidomide 1962 1000s deformed

IUD Device 1974 13 deaths

Tylenol sabotage 1982 6 deaths

Breast Implants 1992 recalled

Glycol Injections 1999 60 children die

Current Issues 22% of all serious deficiencies are temperature related

Quality system documentation

Returns

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BEST PRACTICES AND INDUSTRY INSIGHTS

Serious GDP deficiencies in one market

DESCRIPTION Number %

General storage - temperature control & monitoring 33 19.6

Cold chain - temperature control & monitoring 26 15.5

Lack of or inadequate written procedures 21 12.5

Returns - handling and records 15 8.9

Stock rotation and control 13 7.7

Quality system & duties of the Responsible Person 12 7.1

Premises, equipment, calibration 10 6.0

Segregation of unsaleable goods 9 5.4

General transportation/delivery 7 4.2

Housekeeping and pest control 6 3.6

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IN THIS PRESENTATION WE DISCUSSED

A brief history of GDP

GDP: why, how, how not

I hope I have shared valuable

GDP insights from an auditor’s point of view

GDP insights from an operator’s point of view

I hope this will help you to

Prepare for and follow-up on regulatory, manufacturer, external

and internal audits

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nick.pople@pauwelsconsulting.com

www.pauwelsconsulting.com

FOR MORE INFORMATION

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