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