A Global

Review
of Good
Distribution
Practices

Brought to you by
Cold Chain IQ
 Contents
v Introduction 3
v GDP Goes International 4
v Updates 5
v Worldwide Regulations 10
v More Regulations 12
v A One Page Guide to 11
Global GDP Guidelines
v Sources 13

02
introduction

Good Distribution Practice (GDP) is that part of quality

assurance which ensures products are consistently stored,
transported and handled under suitable conditions as
required by the marketing authorisation (MA) or product
specification. “Changing product portfolios, requirements
for good storage and distribution
With increasing regulatory scrutiny pharmaceutical supply practices, regulatory expectations, quality
chain stakeholders must focus their efforts on meeting the management, and risk assessment factors
requirements of storage, transport and handling of time and bring many challenges to the handling of
temperature-sensitive products. However there are many drug products,”
factors to consider the temperature controlled distribution - Dr. Ümit Kartoglu WHO

and storage of pharmaceutical products.

Regulatory GDP guidance has a large impact on the manufacture

and distribution of pharmaceutical products and with over 30
regulations worldwide, it is a very complex environment. In this
e-book we look at some of the GDP related regulations and
guidance shaping the regulatory landscape for temperature-
sensitive life science products.

03
GDP Goes International
By Dr. Nicola Spiggelkötter
Good Distribution Practice is a global matter. In March 2013 the EU GDP Guideline was published and this led to controversial
discussions. Applying a more global approach it becomes apparent that this guideline is one small contribution among others
(WHO, USP, Canada): For example, the revised USP 36 especially chapter 1079.
What are the joint efforts of all these guidelines that focus on the quality of the supply chain? We see two overall principles:
temperature and qualification.

Aspect 1 Temperature: Aspect 2 Qualification:

The transport of medicinal products should be executed respecting the labeled Equipment and premises have to be qualified, documented evidence has to be
conditions of the product. This implies in the majority of cases storage conditions provided that they perform as they pretend to do. The qualification process is clear
are the same as transport conditions. For cold chain products common and and more or less standardized; the technical reports of the PDA are treated as state
accepted procedure, no debate about that. For ambient products, products that of the scientific and technical knowledge. When we focus on the questions, is the
ask for +15°C to +25°C, general practice when we talk about storage, but a most equipment able to maintain the required temperature in all circumstances? The
recent development when the same temperature requirement are transferred to application of temperature profiles will answer these questions.
transportation.
In regard to passive cooling systems, such as insulation boxes, ISTA profiles are
When we proceed along the pharma supply chain, shipments from the similar are followed. Should these or equivalent profiles be transferred when
pharmaceutical manufacturer to the wholesaler consists of palletized consignment, qualifying trailers and vehicles. A common basis and mutual understanding about
mostly full truckloads. In this segment, conditioning of trailers to ambient conditions these profiles would of immense benefit as it helps to compare the individual
is easy to realize, including the implementation of monitoring devices that assist in performance of the vehicles. Everybody involved in test business knows that test
providing evidence that temperature requirements have been respected in transit. results heavily depend on the intensity of the temperature impact: 20°C or 30°C is
Proceeding further on the road of medicinal product to its final destination, the a decisive question as performance data will be completely different. Evaluating
patient, shipments from wholesalers in the local pharmacy, are the next step. The passive boxes it is understood that test runs are executed in qualified test chambers.
local distribution, the last mile, when we take this term literally, is done with small When we talk about larger units, trailers, test runs in climatic chambers are the
vehicles, very often not equipped with any equipment to condition the load. exception and not the rule, as it should be.
The key question, subject of great controversy in Europe: do the delivery parties
have to provide conditioning devices for all their delivery routes regardless
the transit time? The EU GDP Guideline provides an ambiguous answer: a risk
SOURCE
management approach of the delivery routes decides on which routes temperature
monitoring is obligatory. This leads to misunderstandings: the evaluation of
risk cannot serve as an excuse to accept anticipated deviations, it is not a “card
blanche”. In a more US-oriented scenario, the argumentation slightly differs from
the European: MKT is here the key word, but we will not further enlarge on this
topic, due to the limited space for our paper.

04
European Commission
On March 7, 2013, the European Commission finalised and published the long awaited new Good Distribution Practice (GDP) guideline .
This replaces the current GDP Guideline published in 1994 (94/C 63/03) and will apply to not only to the wholesalers and manufacturers of
pharmaceuticals, but it also incorporates the specific requirements for brokers dealing with pharmaceutical products. Its requirements
(Ref: 2013/C 68/01) will enter into force on 8 September 2013.

The revised guidelines introduce the following changes:

v the maintenance of a quality system setting out responsibilities, processes and risk management principles in relation to wholesale activities;
v suitable documentation which prevents errors from spoken communication;
v sufficient competent personnel to carry out all the tasks for which the wholesale distributor is responsible;
v adequate premises, installations and equipment so as to ensure proper storage and distribution of medicinal products;
v appropriate management of complaints, returns, suspected falsified medicinal products and recalls;
[Website: [Link]
v outsourced activities correctly defined to avoid misunderstandings;
v rules for transport in particular to protect medicinal products against breakage, adulteration and theft, and to
Download the revised guidelines
ensure that temperature conditions are maintained within acceptable limits during transport;
v Specific rules for brokers (person involved in activities in relation to the sale or purchase of medicinal products).

Want to know more? The Table of content is structured in a similar way as the EU GMP Volume
4 and sounds familiar to the pharmaceutical reader. It is divided in the
industry expert Claude following chapters:

Ammann discusses the

1. Quality management
2. Personnel
main changes 3. Premises and equipment
4. Documentation
New EU GDP Guideline – What Are The Main Changes?
5. Operations
The new EU GDP Guideline of 8 March 2013 on Good Distribution
Practice of Medicinal Products for Human Use (2013/C 6. Complaints, returns, falsified medicines and recalls
68/01) is not a slight revision of the previous guideline as it 7. Contract operations
contains completely new content. It is addressed to wholesale 8. Self-inspections
distributors, but applies also to other stakeholders involved in 9. Transportation
the distribution of medicinal products such as brokers. 10. Brokers

05
The following items are new: v Products pending a decision as to their disposition or products that have been
Chapter 1 removed from saleable stock should be segregated either physically or through an
Quality Management describes the Quality System including management review, equivalent electronic system.
continuous improvement, Corrective actions / preventive actions (CAPA) and Risk Chapter 3 also includes a Qualification / Validation subchapter which states that key
management. Deviations must be investigated and CAPA process implemented. equipment should be qualified and key processes (such as storage, pick and pack)
Some interesting precisions are given concerning Risk Management. should be validated, based on a documented risk assessment approach. Observed
v Control and review of any outsourced activities should include risk management qualification and validation deviations should be investigated.
principles. Chapter 5
v Temperature mapping of e.g. storage areas should be repeated according to the Operations specifies that Suppliers must be qualified meaning that they are in
results of a risk assessment possession of a wholesale distribution authorisation, or are in possession of a
manufacturing authorisation which covers the product in question. The wholesale
v A risk based approach should be utilized when planning transportation routes. distributor should carry out due diligence of new suppliers and periodically recheck
Management should have a formal reviewing process including performance that qualification and approval are confirmed.
indicators to monitor the effectiveness of the quality system. Chapter 7
Chapter 2 on Contract operations is adapted from the GMP Chapter 7 and gives Contract Giver
Personnel now requires the wholesale distributor to designate a Responsible responsibility to assess Contract Acceptor competences through audits. Contract
Person with a “desirable” degree in pharmacy. Their main responsibilities are Acceptor should have adequate facilities and experience to carry out contracted
defined as Quality Management / Training / Recall-/ Complaints / Returns / Falsified work safely and efficiently.
Medicines /Approval Suppliers / Outsourcing / Records / Self- Inspections and so on. Chapter 9
The Responsible Person should fulfill his/her Responsibilities personally and should Transportation states that “the required storage conditions for medicinal products
be continuously contactable. “The RP may delegate duties but not responsibilities“. should be maintained during transportation within the defined limits as described
The organizational structure of the wholesale distributor should be clearly described by the manufacturers or on the outer packaging”. This new requirement is in
and the roles and responsibilities of key persons described in job descriptions. contradiction with the new General Chapter <1079> of the USP 35. Storage
Initial and continuous training have to be planned and recorded. conditions are defined during stability studies following ICH stability instructions.
Chapter 3 There are no official guidelines for transport conditions. This point will require
on Premises and Equipment introduces new requirements concerning storage areas. additional efforts from the manufacturers and distributors even for products having
They should be temperature mapped and the mapping should include initial mapping demonstrated sufficiently that their quality remained satisfactory after a short
prior to use, seasonal variations and be repeated based on risk assessment. period out of storage conditions as for example during transportation. The transport
of products by patients from the pharmacy to their house is another source of
v Location of temperature monitors should be based on mapping.
deviations from this requirement.
v All equipment should be maintained to a suitable standard and preventive
Chapter 10
maintenance should be registered.
defines the responsibilities of brokers. They are subject to registration requirements
v Equipment (e.g. temperature monitoring devices) should be calibrated at defined and should set a quality system in place with special emphasis on emergency plan
intervals based on a risk and reliability assessment. in case of recalls.
v Records should be sustained
v Alarm systems should be in place and tested periodically. As conclusion, the revised version of the EU GDP requires
that wholesaler distributors implement a quality system
v Any system replacing physical segregation, such as electronic segregation based SOURCE
corresponding to current standards applied in other industries.
on a computerized system, should provide equivalent security and should be validated.
The timelines for the enforcement is September 8, 2013.

06
Canada INDIa
In 2013 Health Canada begins its 3 year cycle of updating Guidlines In January 2013, The Central Drugs Standard Control Organization
for Temperature Control of Drug Products during Storage and (CDSCO) of India, the country’s Authority for Medicinal Product,
Transportation (GUI-0069). published a draft Guidelines on Good Distribution Practices for
Pharmaceutical Products for public opinion.
Canada is playing an increasingly large role in the biopharma industry, with some of
the major players making significant investments in recent years. The objective of these guidelines is to ensure the quality and identity of
pharmaceutical products during all aspects of the distribution process. These
Health Canada’s latest guidelines, GUI-0069, came into force on April 28th 2011, aspects include, but are not limited to procurement, purchasing, storage,
superseding that released in October 2005. The guide discusses Health Canada’s distribution, transportation, documentation and record-keeping practices.
guidelines for temperature control of drug products during storage and transporta-
tion. The draft guidance does not yet have a date by which it will become effective.

Much of the focus of these new guidelines is in improving monitoring, recording and The Indian pharmaceutical market remains attractive and is expected to grow to
supervision of existing good practice in the field of temperature controlled distribu- US$ 55 billion by 2020 according to the McKinsey & Company report titled “ India
tion, rather than imposing new obligations. Pharma 2020: Propelling access and acceptance realising true potential”.

The additions introduced in GUI-0069 build on the good practice that has formed Although India is one of the most significant emerging markets, there are
around the distribution of temperature controlled pharmaceuticals in recent years, challenges around product quality and regulatory complexity. The new guidelines
in part as a result of the greater emphasis being placed on the growing biopharma- will have a positive impact on the SME industry in India.
ceutical and life sciences industries. The pharmaceutical distribution system in India is undergoing a paradigm shift and
we will continue to see improvements, through compliance with the latest standards
and the implementation of the latest technologies for supply chain management.

In an interview with Cold Chain IQ, Bhusan Mohapatra, Head-Commercial Indian

Immunologicals, noted that the predicted growth in the Indian vaccine market
Find out more about indicates a lot of opportunities for those involved in the cold chain, from the
implementing Health Canada’s
revised guideline: manufacturer to logistics service provider, the technology provider to trace & track
and related software provider.

CLICK To view Guidelines for

Temperature Control of Drug To view the guidelines CLICK here
Products during Storage and
Transportation (GUI-0069) Published on the website of [Link] on 10/01/2013
[Link]

07
China Singapore
China’s importance within the global pharmaceutical industry is Singapore - Health Sciences Authority Guidance notes on GDP
growing. However, this growth requires a supporting infrastructure In August 2010 Singapore’s Health Sciences Authority (HSA)
which allows pharmaceutical companies to transport drugs and published Guidance Notes on Good Distribution Practice.
related equipment in a safe, timely and cost-effective manner. This guide is intended for those involved in the storage, transportation and
Henning Voss, director for World Courier, North Asia, described the challenges and distribution of starting materials and medicinal products, collectively referred to
situation in China as complex. herein as products. This guide applies to all steps in the distribution/supply chain.
“In addition, domestic transport companies do not yet fully understand the many The objective of the guide is to ensure that the quality and integrity of the products is
international standards at play in handling these types of shipments,” Voss said. maintained throughout the distribution chain. The manufacturers, agents, traders,
To remain competitive in the global pharmaceutical industry the country is taking brokers or distributors share important and distinctive roles and responsibilities to
steps to improve the quality of its pharmaceutical supply chain. In January this year ensure that products are of the required quality for their intended use.
the Chinese State Food and Drug Administration (SFDA) published a newly revised
Good Supply Practice for Pharmaceutical Products (GSP), which will go into effect To view the guidelines CLICK here
as of June 1, 2013. The revised guidance sets higher qualification requirements,
increases standards for drug distribution and also has higher requirements for
quality management.
The revised GSP is made of four chapters, including the General Provisions, Quality
Management for Wholesale of Pharmaceutical Products, Quality Management for
BRAZIL
Retail of Pharmaceutical Products and Supplementary Provisions. Brazil’s National Health Surveillance Agency (Anvisa) opened
The revised GSP means that many local pharmaceutical companies will need to lift a consultation on the 4th April to propose the formation of an
their game when storing and handling drug products or they risk getting left behind electronic tracking system for drugs from point of production
their competitors through to the point of dispensing to the patient.
Charlie Xu, Vice President for Clinical Operations at Frontage Lab China said that
compared to multinational companies, many local players don’t have stringent
The proposed tracking system is to be based on the two-dimensional barcode, the
compliance records and the regulations are intended to raise the standards of GSP
Datamatrix, that will be included on sales packaging as well as secondary packaging
in the country.
such as pill packs and hospital packs.
“Good supply practices amongst local pharmaceutical companies are not great
compared to international players. Unlike large companies, many smaller players don’t
The CEO of Anvisa, Dirceu Barbano said: “Companies holding registration
have in-built QAQC [Quality Assurance and Quality Control] systems,” said Mr Xu.
with Anvisa will be responsible for placing on each package a Unique Drug
To view or download the SFDA Identifier (IUM) formed by the drug registration number for the product
Good Supply Practice Decree, containing thirteen (13) digits, plus the serial number, expiration date and lot
click here number.”

To view or download the SFDA The comment period closes on

Good Supply Practice guidance, the 9th May 2013. For an outline
click here of the proposal CLICK HERE

08
USA
U.S. Pharmacopeia GS1 Healthcare US
<1079> Good Storage and Distribution Practices for Drug Products GS1 Healthcare US is an industry group working towards open,
– This general information chapter provides general guidance on global standards to help healthcare companies improve the
good distribution and storage practices to ensure drug products accuracy, speed, and efficiency of the supply chain and care delivery.
(medicines) reaches the end user quality intact. The first phase of the California state drug pedigree requirements become
mandatory in 2015, marking the beginning of product serialisation and visibility in
To view the chapter CLICK here the US healthcare supply chain. Earlier this year the GS1 Healthcare US Secure
Supply Chain Task Force published a new guideline to support the pending
This general information chapter describes a set of recommended practices for requirements titled “Applying GS1 Standards to U.S. Pharmaceutical Supply Chain
helping to ensure supply chain integrity for drug components (drug substances and Business Processes to Support Serialization, Pedigree and Track & Trace.”
excipients) and drug products (medicines). Worldwide efforts to help protect the
integrity of medicine supply systems are ongoing and quickly changing. The non-
mandatory information in this chapter is intended to contribute to the growing body “This guideline will help organisations take an active role in the
of resources and best-practices information to enhance and protect supply chain transformation of the healthcare system, meeting the goals of patient safety
integrity. and regulatory compliance while making the supply chain more efficient,”
said Siobhan O’Bara, senior vice president of industry engagement, GS1 US.
“This new guideline should be the ‘first stop’ for all organizations that are
preparing their pharmaceutical supply chain systems and business processes
to meet pending improved supply chain security regulatory requirements.”

The new guideline covers product serialisation, supply chain data exchange for
pedigree and traceability and pilot learning and best practices.

To read the guideline click here

09
Worldwide Regulations
World Health Organization (WHO)
v Good Distribution Practices for pharmaceutical products TRS No. 957, Annex 5
(2010) [Link]
[Link]
v Model requirements for the storage and transport of time and temperature
sensitive pharmaceutical products TRS No. 961, Annex 9 (2011)
[Link]
Website: [Link]/

International Pharmaceutical Excipients Council (IPEC) Europe

The IPEC –Europe Good Distribution Practices Audit Guideline FOR
PHARMACEUTICAL EXCIPIENTS 2011 [Link]
IPEC_Europe_GDP_Audit_Guide__-_Revision_2011_final.pdf
Website: [Link]

International Air Transport Association (IATA)

IATA is the governing Body that creates regulation for international air transport,
including regulations controlling the transport of dangerous goods by air
v Chapter 17 “Air Transport Logistics for Time and Temperature Sensitive
Healthcare Products” [Link]
Documents/[Link]
v IATA Perishable Cargo Regulations (PCR)
Website: [Link]

10
[Link]
A One Page Good Distribution Practice (GDP) is the part of quality
assurance which ensures that products are consistently

Guide to
stored, transported and handled under suitable IATA v
condition as required by the marketing authorisation r Chapter 17 “Air Transport Logistics for
Time and Temperature Sensitive
(MA) or product specification. There is no single global
Global GDP
Healthcare Products”
GDP standard. Cold Chain IQ has created this easy- IATA Perishable Cargo Regulations (PCR)
to-assimilate summary of GDP requirements around

Guidelines the world, enabling you to navigate the landscape. You

can keep it as a handy reference, share it around your
colleagues or even stick it on your wall!
european commission
r Revised Commission guidelines on the
distribution of medicinal products in the
EU will enter into force September 8, 2013
china
r Coming Soon: The newly revised Good
Supply Practice for Pharmaceutical
Products (GSP) will go into effect as of
r Guidelines on Good Distribution Practice June 1, 2013
KEy of Medicinal Products for Human Use State Food and Drug Administration, P.R.
uk r The principles of GDP are stated in China (SFDA)
Cick for more information r Guidance in the Transportation of Medicinal Directive 92/25/EEC
Products, ambient and refrigerated European Medicines Agency (EMA)
Medicines and Healthcare products
Regulatory Agency (MHRA)
canada
r Guidelines for Temperature Control of
denmark
r Executive Order No. 823 (IDRAC
Drug Products during Storage and ireland 148449): Distribution of Medicinal India
Transportation (GUI-0069) r IMB - Medicinal Products (Prescription Products, August 2012 r Guidelines on Good Distribution
Health Canada and Control of Supply) (Amendment) Danish Health and Medicines Agency Practices for Biological Products
Regulations 2007 (SI 201 of 2007)
r DRAFT: Guidelines on Good Distribution
r IMB Guide to Control and Monitoring of
united states Storage and Transportation Temperature
Practices for Pharmaceutical Products
Central Drugs Standard Control
r USP General Chapter <1079> Good
Storage and Shipping Practices
Conditions for Medical Products and
Active Substance
Worldwide Organization (CDSCO)
WHO v
r USP General Chapter <1083> Good Irish Medicines Board (IMB) r Good Distribution Practices for
Distribution Practices—Supply Chain pharmaceutical products TRS No. 957,
Integrity United States Pharmacopeia Annex 5 (2010)
(USP)
r Model requirements for the storage
and transport of time and tem-perature
sensitive pharmaceutical products TRS singapore
No. 961, Annex 9 (2011) r DRAFT Guidance notes on Good
World Health Organization (WHO) Distribution Practice
Health Sciences Authority (HSA)
Brazil IPEC Europe v
r Opens public consultation on GMP r The IPEC –Europe Good Distribution
and GDP Requirements on January 15. Practices Audit Guideline FOR
Deadline for comments March 12, 2013 PHARMACEUTICAL EXCIPIENTS 2011
The National Health Surveillance Agency International Pharmaceutical Excipients
(Anvisa) Council (IPEC)

PDA v
Argentina r PDA Technical Report TR 52 (Aug 2011)
r ANMAT Ley 26.492, Regulación
Guidance for Good Distribution Practices
(GDPs) for the Pharmaceutical Supply
Australia
de la cadena de frío de los r Australian code of good wholesaling
Chain
medicamentos, 2009 practice for therapeutic goods for
r PDA Technical Report TR 53 Guidance
National Administration of Drugs, Foods human use
for Industry: Stability Testing to Support
and Medical Devices (ANMAT) Therapeutic Goods Administration (TGA)
Distribution of New Drug Products
r PDA Technical Report TR 58 Risk
Management for Temperature-
This information is accurate to the best of the respondents knowledge at that time, and may subsequently have changed. Cold Chain Controlled Distribution
IQ cannot take responsibility for the accuracy of this information. Reference: David Ulrich presentation “Good Distribution Practices Parenteral Drug Association(PDA) Connect to a cold chain
(GDP‘s) & Pharma Supply Chain Management” at the 2011 PDA Pharmaceutical Cold Chain Management Conference. IQ social network
More Regulations
Australia South Africa
v Australian code of good wholesaling practice for therapeutic goods for human use v MEDICINES CONTROL COUNCIL, GOOD WHOLESALING PRACTICE FOR
[Link] WHOLESALERS, DISTRIBUTORS and BONDED WAREHOUSES, 2012. Wholesaler
Therapeutic Goods Administration (TGA) distribution forms part of the supply chain of pharmaceutical products
Website: [Link] manufactured. Wholesalers/ Distributors are responsible for the effective, efficient
and safe handling, storage and distribution of such products ensuring the quality
Argentina and identity of these during all aspects of the wholesaling and distribution
v ANMAT Ley 26.492, Regulación de la cadena de frío de los medicamentos, 2009 process. This Guideline sets out appropriate steps for meeting this responsibility.
[Link] [Link]
cadena_frio.pdf Medicines Control Council
National Administration of Drugs, Foods and Medical Devices (ANMAT) Website: [Link]/
Website: [Link]/webanmat/institucional/que_es_la_ANMAT_en.asp
Taiwan
Denmark v TFDA Precaution of on-site sampling for vaccine testing and sealing operation
v Executive Order No. 823 (IDRAC 148449): Distribution of Medicinal Products, (cold chain temperature monitoring) 2010
August 2012 {hyperlink to [Link] Taiwan Food and Drug administration
supervision/company-authorisations-and-registrations/manufacture-and-
[Link]/EN/[Link]
import-of-medicines-and---ermediates/gdp-and-gmp
Danish Health and Medicines Agency United Kingdom
Website: [Link] v Guidance in the Transportation of Medicinal Products, ambient and refrigerated
[Link]
Czech Republic [Link]
v Czech Republic GDP Guidelines DIS-15 V.1 2009 v MHRA GDP Risk Assessment Strategy 2008, GDP Risk Assessment Strategy 2009
v Guidelines for Correct Distribution Practice of Human Medicinal Products DIS-11 2009 Updated Policy on returns of non-defective refrigerated (2-8c) medicinal products
State Institute for Drug Control 2010
Website: [Link]/ v Medicines and Healthcare products Regulatory Agency (MHRA)
Egypt Website: [Link]/Howweregulate/Medicines/
v MOH Minister Decree for Wholesalers 2009 Inspectionandstandards/GoodDistributionPractice/[Link]
Egyptian Drug Authority
Website: [Link]
Malaysia
v Guidelines on Good Storage Practice (GSP), 2004
v Guidelines on Good Distribution Practice (GDP); 1st Edition 2011 [Link]
[Link]/[Link]?menuid=90&q=gdp
National Pharmaceutical Control Bureau (NPCB) Ministry of Health (MOH) Malaysia
Website: [Link]

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[Link]

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