GMPKongress2013 Session1 GDP Kauer

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HC Compliance
September 26
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, 2013
GDP Good Distribution Practice
September 26th, 2013
GDP Good Distribution
Practice
The new EU guidelines and their implementation
Klaus Kauer
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Agenda
Current GDP regulations and guidelines
What needs to be done by the pharmaceutical industry to be GDP compliant?
What do the new guidelines mean for logistics companies?
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FROM GMP to GDP
The major transformational trend for the Pharma / Healthcare Supply Chain is
that GDP has been separated from but is still aligned with GMP (Good
Manufacturing Practice). That means GDP becomes more important especially
from the perspective of an auditor and or inspector.
It is of key importance that the quality and the integrity of the medicinal
products is maintained during the entire supply chain from the manufacturer to
the patient.
Todays distribution network for medicinal products is increasingly complex
and involves many players. The revised guidelines, published today, lay down
appropriate tools to assist wholesale distributors in conducting their activities
and to prevent falsified medicines from entering the legal supply chain.

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GDP
Good Distribution Practice (GDP) regulates the distribution of healthcare
products from the premises of the manufacturer to the end user and is
therefore part of the entire quality assurance process. It ensures that products
are consistently stored, transported and handled under suitable conditions as
required by the marketing authorization or product specifications during all
aspects of the distribution process.
Worldwide, there are more than 35 GDPs (e.g WHO and FDA/EU). These are
more or less aligned, but some have specifics like e.g. Argentina, Brazil, Saudi
Arabia, etc.
Regulatory bodies have become stricter regarding the fulfillment of the GDP
regulations like e.g. Saudi Arabia (Statement of the SFDA): No shipment of
pharmaceutical products imported to the Kingdom will be cleared if it was
proved that they were transported in non-cooled containers or stored in such a
way contrary to the conditions recommended.
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GDP Regulations I
Country Regulations WWW Link
EU Guidelines on Good Distribution Practice of Medicinal Products for
Human Use (2013/C 68/01) (as of 7 March 2013)
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:
2013:068:0001:0014:EN:PDF

WHO WHO Technical Report Series, No. 957, 2010 good distribution
practices for pharmaceutical products
http://www.who.int/medicines/areas/quality_safety/quality_assurance/
GoodDistributionPracticesTRS957Annex5.pdf
Model requirements for the storage and transport of time and
temperature sensitive pharmaceutical products TRS No. 961,
Annex 9 (2011)
http://whqlibdoc.who.int/trs/WHO_TRS_961_eng.pdf
USA 21 Code of Federal Regulations - Parts 210 and 211
(21CFR211.150)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?
fr=211.150
21 Code of Federal Regulations 820 Medical Devices
http://www.fda.gov/medicaldevices/deviceregulationandguidance/
postmarketrequirements/qualitysystemsregulations/
USP (1083) Good Distribution PracticesSupply Chain Integrity
http://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/revisions/c1083.pdf
USP(1079) Good Storage and Shipping Practices for Drug
Products
https://mc.usp.org/sites/default/files/documents/GeneralChapterPDFs/
c1079%20USP36.pdf
Canada

Guidelines for Temperature Control of Drug Products during
Storage and Transportation
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/compli-conform/gmp-bpf/docs/
GUI-0069-eng.pdf
Argentina Regulacin de la cadena de fro de los medicamentos.
http://www.anmat.gov.ar/webanmat/Legislacion/Medicamentos/
Ley_26492_cadena_frio.pdf
Brazil GMP and GDP Requirements - National Health Surveillance
Agency (Anvisa)

http://portal.anvisa.gov.br/wps/content/anvisa+portal/anvisa/sala+de+imprensa/
menu+-+noticias+anos/2013+noticias/consulta+publica+reune+normas+sobre
+boas+praticas+de+fabricacao
Denmark Good manufacturing practice (GMP) and good distribution practice
(GDP)
http://www.dkma.dk/en/topics/authorisation-and-supervision/company-
authorisations-and-registrations/manufacture-and-import-of-medicines-and---
ermediates/gdp-and-gmp
UK Guidance in the Transportation of Medicinal Products, ambient and
refrigerated
http://www.mhra.gov.uk/home/groups/is-insp/documents/websiteresources/
con137881.pdf
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GDP Regulations II
Country Regulations WWW Link
Ireland Medicinal Products (Prescription and Control of Supply) (Amendment)
Regulations 2007
http://www.dohc.ie/legislation/statutory_instruments/pdf/si20070201.pdf?direct=1%20
IMB Guide to Control and Monitoring of Storage and Transportation
Temperature Conditions for Medical Products and Active Substance
http://www.coolpack.com/admin/documents/Regulatory/Ireland/IND-003.01x.pdf
China Good Supply Practice for Pharmaceutical Products
http://eng.sfda.gov.cn/WS03/CL0757/78507.html

Australia Australian code of good wholesaling practice for therapeutic goods for
human use
http://www.tga.gov.au/pdf/manuf-cgwp-tg.pdf

Singapore GUIDANCE NOTES ON GOOD DISTRIBUTION PRACTICE
http://www.hsa.gov.sg/publish/etc/medialib/hsa_library/health_products_regulation/gmp/
files_1.Par.84852.File.dat/GUIDE-MQA-013-009.pdf%20
India GUIDELINES ON GOOD DISTRIBUTION PRACTICES FOR BIOLOGICAL
PRODUCTS
http://cdsco.nic.in/GUIDELINES.pdf
GUIDELINES ON GOOD DISTRIBUTION PRACTICES FOR
PHARMACEUTICAL PRODUCTS
http://www.cdsco.nic.in/GDP%20final%20draft%20for%20pharmaceutical
%20products_09012013%20-%20for%20website.pdf
Saudi Arabia Food & Drug Authority Temperature Monitors
Taiwan Precaution of on-site sampling for vaccine testing and sealing operation
(Draft)
Romanian Directive Legislation Change - Control of temperature/humidity during transportation
Singapore Health Sciences Authority Guidance notes on GDP (Draft)
Czech GDP Guidelines: DIS-15 version 1 Monitoring and temperature control
during storage and transport of medicinal products
GDP Guidelines: DIS-11 Guidelines for correct distribution practice of human
medicinal products
Egypt Minister Decree for Wholesalers Circular No. 4/2009
Indonesia GMP Requirements on warehousing or distribution
Pakistan Drug Act of 1976
PDA: PDA Technical Report TR 52 (Aug 2011) Guidance for Good Distribution
Practices
(GDPs) for the Pharmaceutical Supply Chain

IATA: Perishable Cargo Regulations (PCR); Chapter 17 Air Transport Logistics for
Time and Temperature Sensitive Healthcare Products
http://www.iata.org/whatwedo/cargo/pharma/Documents/time-and-temperature-label-faq.pdf

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Quality
Management
(Chapter 1)
Premises and
Equipment
(Chapter 3)
Documentation
(Chapter 4)
Subcontractor
Management
(Chapter 7)
Transportation
(Chapter 9)
New EU GDP Guide in general: Structure

Main
Topics
1. Quality Management
2. Personnel //Training
3. Premises and Equipment
4. Documentation
5. Operations
6. Complaints, Returns, etc.
7. Outsourced Activities //Subcontractor Management
8. Self-Inspections
9. Transportation
10. Specific Provisions for Broker*
(* Not valid for a Transportation Company)
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GDP Requirements of the Pharmaceutical Industry
Chapter 3 Premises and Equipment
Quality Technical Agreement between contract giver and contract acceptor (Contract / SLA /
QTA) for all qualified facilities

Chapter 7 - Subcontractor Management (outsourced activities)
Agreement between contract giver and contract acceptor (Contract / SLA)
Any activity covered by GDP must be correctly defined, agreed and controlled.
Supplier audits should be performed prior to use (wherever possible)
Frequency of audits depends on the entire risk of service
Subcontractor is not allowed to pass service to a third party without contract giver approval
The performance of the subcontractor (including number of complaints, deviations, etc.) must be
regularly monitored and reviewed, results must be documented (management by KPIs)
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GDP compliant Subcontractor Management
Subcontractor
Management
Auditing
SLAs
Management
by KPIs
Selection
process
Main Topic
Sub-Topics
A documented management of outsourced activities / Subcontractor Management
including selection process, contracts and written agreements (Service Level
Agreements according to GDP requirements) must be in place
The selection of subcontractors is based on predefined roles and they shall be
audited prior to use.
GDP related KPIs must be defined, integrated within the SLA, monitored and
reviewed.
As part of the signed contract, Service Level Agreements according to GDP
requirements must be signed by all service providers.
Subcontractors must be audited according to an audit schedule on a predefined
basis in line with the entire risk of service.
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What needs to be done by the Pharmaceutical Industry to be
GDP compliant?
Temperature-controlled shipments
Investigation of temperature excursions
Equipment suitable for use
Written procedures and risk assessment of delivery routes
Use of harmonized temperature ranges and dedicated labels (Air Freight)
Use of qualified equipment only:
Road: ATP certified and qualified trucks http://www.tuev-sued.de/uploads/images/1139221651472619300056/ATP-Info.pdf [Accord relatif
aux transports internationaux de denres prissables et aux engins spciaux utiliser pour ces transports]
Air: Use of qualified (according to their use) packaging units only (active as well as passive)
Ocean: Reefer Guides
Hamburg Sd: http://www.hamburgsud-line.com/hsdg/media/sharedmedia/dokumente/brochures/Reefer_guide.pdf
Hapag Lloyd: http://www.hapag-lloyd.de/de/products_and_services/reefer_cargo_handling.html
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What do the new guidelines mean for logistics companies (LC)?
Chapter 1 - Quality Management
A responsible person must be designated . He or she must be appropriately competent and
experience d as well as knowledgeable about and trained in GDP (job description must clearly
define responsibility and authority to fulfill duties).
The quality management system as well as the quality objectives are within the responsibilities
of senior management (management, review and monitoring) and must be reviewed at least
once a year (quality report)
All activities must be clearly defined, fully documented, trained and systematically reviewed. A
training system must be available, all personnel involved should be trained.
A CAPA process aligned risk management process (referring to ICHQ9) has to be established.
Risk management must ensure that the evaluation of risk to quality is based on scientific
knowledge and experiences. Also, a change management must incorporat quality risk
management principles. Significant changes must be validated.
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What do the new guidelines mean for LC II?
Chapter 2 - Personnel
Key person regarding quality and compliance must be addressed (duties and responsibilities).
Furthermore, the key person must train personnel in all relevant aspects.
Job description for key positions including deputyship must be specified.
Personnel must maintain competence in GDP including periodic training. The effectiveness of
training must be periodically assessed (at least once a year).
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What do the new guidelines mean for LC III?
Chapter 3 Premises and Equipment
Focus on ALL temperature ranges (not 2C to 8C only)
Qualified facilities:
Initial mapping of the facility to specify the position of monitoring devices.
Equipment used to control or monitor the environment must be calibrated.
Appropriate alarm systems must be in place and regularly tested.
Planned maintenance should be in place for key equipment.
Processes for cleaning, preventive pest control must be available
The presence of food drink, smoking material or medicinal products for personal use is
prohibited
In case a computerized system is brought into use, the system must be validated prior to use.
Refrigerated vehicles:
Equipment must be maintained and calibrated regularly (at least once a year).
Mapping of vehicles should be done taking into account seasonal variations.
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What do the new guidelines mean for LC IV?
Chapter 4 Documentation
Good documentation constitutes an essential part of the quality system
Documentation must be approved, signed and dated by appropriately authorized persons as
required (written in a language understood by personnel, i.e. clear, unambiguous and
comprehensive to all personnel) .Training records must be available.
Suitable documentation which prevents errors from spoken communication must be available
Documents should be regularly reviewed and kept up to date. Version control should be applied
to procedures.
A SOP System must be in place. In case a computerized document management system is
used, validation is required.
Each employee should have access to all necessary documentation (SOP) for the task executed
Documents should be retained for the period of at least 5 years
If its not documented, its not done.
If its not signed, approved and trained, its worthless.
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What do the new guidelines mean for LC V?
Chapter 5 Operation (Warehousing)
The new guideline is more specific regarding the qualification of subcontractors.
Regarding warehousing the following topics are addressed: separation, destruction of products.
NEW "FIFO" ("first in first out") has been replaced by "FEFO" ("first expired first out")

Chapter 6 - Complaints, Returns of goods, fakes, etc. (Warehousing)
Everybody involved in the handling and distribution process must / shall be able to identify such
products to reduce the patient risk. (Topic behind: training of staff)
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What does the new guidelines mean for LC VI
Chapter 7 - Subcontractor Management
Any activity covered by GDP must be correctly defined, agreed and controlled.
An approved and signed agreement//contract by both parties must be available, including clearly
defined duties of each parties.
Supplier audits should be performed prior to use (where ever possible)
Frequency of audits should be done based on the entire risk of service
Subcontractor is not allowed to pass service to a third party without PA approval
The performance of the subcontractor (including number of complaints, deviations, etc.) must be
regularly monitored and reviewed, results must be documented (management by KPIs)
Chapter 8 - Self inspection
Internal audit needs to be done and an audit schedule must be available.
NEW, internal audits can be done by third parties as well.
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Specific GDP Requirements of the PI III
Chapter 9 Transportation
Mandatory use of qualified equipment and vehicles
Temperature conditions must be maintained within acceptable limits during the whole transport
Temperature monitoring equipment must be calibrated at regular intervals
A risk-based approach should be utilized when transportation is planned
A procedure must be in place for managing temperature deviations
Maintenance of used vehicles must be clearly defined within a procedure, records must be
available for all used vehicles, including cleaning and safety precautions.
For the intermediate storage, requirements are the same as for storage. (Chapter 3) Medicinal
product should be transported in accordance with the storage conditions indicated on the
packaging information.
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Summary
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GDP compliant Quality Management
Quality
Management
Document
Management /
SOPs
Training & Job
Description
Risk &
Change
Management
Deviation
Management
QM
Handbook-
Report
Main Topic
Sub-Topics
A global GDP-compliant quality management system must be established, including a QM
handbook. Quality and compliance-related goals according to key processes must be
defined and reviewed at least once a year, resulting in a QM annual report.
A quality management handbook must be established describing all key processes. Quality
objectives are within the responsibilities of senior management (management, review and
monitoring) and must be reviewed at least once a year (quality report).
A document management system / process must be in place. All quality / compliance-
related documents like SOPs, WIs, etc. must be approved, signed and dated by authorized
persons. Documents must be archived for a minimum timeframe of five years.
The organization must establish a documented deviation management (incident handling)
process including a CAPA (corrective and preventive action) process, aligned with the risk
management process (referring to ICHQ9).
Key person regarding quality and compliance must be addressed (duties and
responsibilities) as well as personal training. Maintain competence in GDP including
periodic training. The effectiveness of training must be periodically (min. once a year)
assessed.
A documented change and risk management process must be in place. For quality-relevant
changes risk assessment must be done, therefore significant changes must be validated
and approved by the related quality organization.
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GDP compliant
Qualification & Validation processes
Qualification
& Validation
V. of
Processes
V. of IT
Systems
Q. of Facilities
Q. of Service-
providers
Main Topic
Sub-Topics
All service providers must be qualified according to predefined roles in line with the
GDP requirements.
Processes regarding qualification and validation must be defined and rolled out.
Storage facilities and used equipment for temperature-controlled products must be
qualified (authorization, certification and compliance-audit prior to use).
The potential risk of computerized systems must be evaluated and systems must
be validated depending on the result of the RA (according to predefined roles inline
with e.g.: EU GMP Annex 11 and US 21CFR Part11)
Process validation (e.g.: transport validation) must be defined
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GDP Compliance Process Map
Quality
Management
Qualification &
Validation
Subcontractor
Management
Document
Management /
SOPs
Training & Job
Description
Risk & Change
Management
V. of Processes Auditing
SLAs V. of IT Systems
Management by
KPIs
Q. of Facilities
Selection-
process
Q. of Service-
providers
Deviation
Management
QM Handbook,-
Report
Main Topics
Sub-Topics
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In a nutshell
Outsourced activities must be correctly defined, service level agreement must be signed by all
parties involved
Regularly Business Review Meetings (KPI review) must be scheduled
Rules for communication must be defined and established (claims, deviations, changes, etc.)
All GDP-related processes must be documented, approved, signed , trained and documented
The maintenance of a quality system setting out responsibilities, processes and risk management
principles must be in place
All staff handling pharmaceutical shipments must be trained.
Adequate premises, installations and equipment must fulfill proper requirements for storage and
distribution of products
Appropriate management of complaints, returns must be in place
Rules for transport must be defined particularly to keep the product integrity and to ensure that
temperature conditions are maintained within acceptable limits during transport;
The revised guidelines are entered into force, September 08
th
, 2013.
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Real-Time Visibility & Intervention Capabilities with PanCool
GDP Trucking
Cool rooms /
GDP
Defined process for
de-consolidation or re-
icing
Full control on
OCN and with
selected cariers
PanCool
Set-up
Real-time
Visibility
Manufacturer
GMP
PanCoE /
GDP Hub
Approved reefer truck
Approved reefer truck
Airport /
Terminal /
Tarmac /
Loading
Airport /
Terminal /
Tarmac /
Loading
PanCoE / Distribution
Center / GDP Hub
Consignee

Qualified plane
Full control on OCN
and with selected
cariers
GDP Trucking
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HC Compliance
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Global HC Compliance Support
Process design
Appoval of Master SOP
Quality Agreement
Support of validation and qualification activities
Train and support the process related Quality Persons
Compliance topics in QBR / MBR
THANK YOU FOR YOUR ATTENTION!

QUESTIONS?

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Klaus Kauer

Industry Vertical Healthcare
VP, Corporate IV Healthcare Compliance Manager

Panalpina Management Ltd., Corporate Head Office,
The Squaire 13, Am Flughafen, 60549 Frankfurt am Main

Phone: +49 69 698 678 283
Mobile: +49 172 1850 728
E-Mail: klaus.kauer@panalpina.com

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