Review Article

A review on good distribution practices

Sohini Kandar*, H. V. Gangadharappa

ABSTRACT

Quality in the manufacturing and distribution of medicinal product is regarded to be the most important component
of the pharmaceutical industry. The quality of the medicinal products corresponds to its goal of patients’ healing.
Distribution of the drug is a central operation in the integrated pharmaceutical supply chain management. Specific
storage environments and shelf life are the two difficulties of the supply chain for pharmaceutical products. Therefore,
the management of the quality of medicinal products during delivery is crucial. To resolve this issue, regulatory
authorities have provided guidelines on good distribution practices (GDPs). It is regarded as an integral basis of the
pharmaceutical supply chain of management for ensuring the orderly delivery of medicinal products. Everyone involved
in the supply chain must conform to relevant laws and regulations to preserve the actual quality of medical products.
This article basically deals with the basic concept, importance, elements, global picture, and chapters involved in the
GDPs guidelines.

KEY WORDS: Good distribution practices, Medicinal product, Pharmaceutical supply chain management, Quality

INTRODUCTION manufacturers to customers.[3] The different types of

medication (e.g., syrups, tablets, injectables, etc.) must
A core principle for the pharmaceutical supply chain be carried and stored under varying environmental
of management is good distribution practices (GDPs) conditions. The storage specifications for liquid, solid,
to ensure the efficient delivery of medicinal products and injectables shall differ considerably. The drugs
from production site to retailers.[1] GDP leads to the of the cold chain are maintained at a temperature of
regulatory standards for the wholesale business of 2–8°C. Therefore, the degree of concern is increased
pharmaceutical goods so that their consistency and for cold chain products because of the risk of product
authenticity are protected from producer to final failures during customers’ quality checks.[3]
consumers in the supply chain. Good manufacturing
practice (GMP) goes beyond delivering the final
product, including the purchase, storage, and transport
of APIs and other components before production.[2] GDP
has been established as a quality assurance component
by the World Health Organization (WHO) to ensure
reliable storage, transport, and handling of products
in acceptable condition, as specified under the
marketing authorization or product specification. The
complexities of the supply chain for pharmaceutical
products are due to their established shelf life and
storage conditions. Figure 1 described the distribution
process of drugs and pharmaceuticals from

Access this article online

Website: jprsolutions.info ISSN: 0975-7619

Figure 1: Distribution method of pharmaceutical product[3]

Department of Pharmaceutics, Pharmaceutical Quality Assurance Group, JSS College of Pharmacy, JSS Academy of Higher
Education and Research, Sri Shivarathreeshwara Nagara, Mysuru, Karnataka, India

*Corresponding author: Sohini Kandar, Department of Pharmaceutics, Pharmaceutical Quality Assurance Group, JSS
College of Pharmacy, JSS Academy of Higher Education and Research, Sri Shivarathreeshwara Nagara, Mysuru - 570 015,
Karnataka, India. Phone: +91-9932633232. E-mail: sohinikandar1995@gmail.com

Received on: 16-01-2020; Revised on: 14-02-2020; Accepted on: 22-03-2020

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 Sohini Kandar and H. V. Gangadharappa

BASIC CONCEPTS OF GDP[4] Supply Chain Risk Management

To determine, define, and understand the critical areas of
Nine core principles are defined briefly in accordance
the supply chains, importers should develop a risk-based
with the GDP guidelines:
method and precisely delegate responsibility. For supply
1. National legislation must ensure that pharmaceutical
chain activities, a structuralized quality assurance system
products are sold under the GDP guidelines
and a process to publicize supply chain details should
2. The distributor should be licensed and approved
be developed within the company. Drug substances and
and responsible for the safe delivery of medicines
excipients may be supplied by a short supply chain or
or medical products
a long and complicated supply chain involving several
3. Only licensed individuals or corporations should be
countries. Importers should themselves test or use
able to purchase or sell pharmaceuticals
existing third party auditing companies on product
4. Distributors should only sell a drug product in
substances and excipients producers and should
countries where it is allowed
not depend on manufacturer’s questionnaire. If the
5. Distributors may only provide their services to
substance’s identity and its exact production locations
companies approved to manufacture the drug
are not established or verified (show factory) then
product or work with it
either the original company or subcontractors may be
6. Duty and obligation can only be subcontracted to
producing the item in another location (shadow factory)
third parties holding a suitable license
on condition that it does not meet GMP requirements.
7. Distributors or their agents can only distribute
The following are the suggested measures:
pharmaceutical products to individuals or organizations
approved to purchase the pharmaceutical drugs • Suppliers and subcontractors’ names and
8. The organization or person under contract must be geographical locations are verified
accurately approved • The credibility of a company is investigated
9. Pharmaceutical products shall be available in online • The products or materials are checked by inspection
only for licensed and approved pharmacies or other or checking at different points/stations of the supply
approved organizations only. chain.[8]

IMPORTANCE OF GDP Efficient Supplier Relationship Creation

A necessary initial investigation and assessment
GDPs define the minimum requirements that should
of the supplier should be performed on site or
be followed by the distributors or wholesalers for
person, as a quality audit, and in conformity with
assuring that the drugs are maintained over the entire
appropriate regulatory requirements for the country of
supply chain. GDP should be enforced by means of a
importation (e.g., current GMP [cGMP] adherence to
quality program managed by the supply chain staff and
the U.S. markets). This method ensures that a reliable
the pharmaceutical product network to assure that:[5,6]
framework of quality is in place and that the product
1. The medicinal products are approved in compliance
or service to be imported is properly understood. To
with the law of land
resolve any areas of concern, corrective or preventive
2. Medicines are kept in the appropriate environment
measures should be dealt with and addressed where
throughout all times even during shipping
appropriate. The recommended measures include:
3. Contamination is avoided by or from other goods
• Analyzes the credibility of the distributor by
4. Supply of stored medicines is properly turned-over
checking his company ranking or any misuse or
5. In a sufficient time frame, the right goods hit the
other breaches of intellectual property or trademarks
correct address or[7]
• Determine the company’s long-term market
6. Harmonizing supply of drug in the public sector[7]
sustainability and commitment to the health and
7. To make sure that medicines are distributed fairly (and
quality of the drug and its reputation as a supplier
re-distributed, if necessary) throughout the world.[7]
for the pharmaceutical industry
The supplier will also implement a monitoring system • Determine the regulatory compliance of the
for the identification and successful recovery of manufacturer with the exporting and importing
defective items. GDP also refers to the manufacturing, countries.[8]
storage, and transport of active pharmaceutical materials
Creating a Reliable Supply Chain Network
and other materials used for medicinal products.[5]
Importers may strengthen methods, policies,
ELEMENTS OF GDP AS PER USP specifications, procedures, and documents related to
product protection and supply chain integrity by meeting
According to USP <1083> the main components the criteria of Security Assurance Standard of the
of good distribution practices are mentioned in American National Standards Institute other equivalent
Figure 2[6]. The components are as followed. standards. The following are the required measures:

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 Sohini Kandar and H. V. Gangadharappa
Figure 2: Main good distribution practices components depending on USP<1083>[6]
• Develop a management framework based on the
safety of products and integrity of the supply chain
• Develop and record specified roles and duties for
resolving credibility issues in the product and supply
chain, including falsification robbery and diversion
of products
• Assuring that employees have adequate preparation,
expertise, experience, and skills to fulfill their duties
and responsibilities.[8]
Counterfeit Drugs and Medical Devices
Counterfeit medicines are false medicines. It may be
toxic or it may contain incorrect active components or
no active components. The correct active ingredient
may be present but at the wrong dose. Counterfeit
medicines are illicit and can affect health.[9] The most
common reason for manufacturing a counterfeit drug
product is to achieve a commercial benefit by supplying
a small quantity of the medication or even by failing to
supply some medication substance or replacing another
cheaper drug substance. Counterfeited medicines may
include the right quantity of ingredients but may not
be produced by GMPs and/or manufactured at sites not
registered with the appropriate regulatory authorities.
Counterfeiters are also using modern techniques for
packaging and printing to make false labels as well
as primary and secondary packaging to confuse
pharmaceutical firms, regulators, and consumers.
Drug Invention Today | Vol 13 • Issue 7 • 2020
They may also manufacture false labels and primary
packaging with altered shelf-life dates.[8]
Packaging Technologies
Packaging techniques such as authentication, tamper-
evident designs, and serialization are an essential
component for brand security and refer to both the
main and/or secondary packaging product labels.
Techniques for authentication are categorized as
transparent, hidden, and forensic. In an approach
described as “layering,” tamper-evident designs can
be combined with more elaborate authentication
technologies. One drawback of these methods is that
it does not protect the product.[8]
Drug Pedigrees System
A drug pedigree is a declaration of origin which
established the date and address of all parties
concerned with each prior selling, purchase, or
exchange of a drug. The details should be stored in
paper or electronic form (e-pedigree) so that the supply
chain for drugs can be protected against the entry of
counterfeit, lost, misreported, adulterated, sub-potent,
misbranded, non-standard, or expired products. An
e-pedigree is just electronic documentation that meets
the specification of a pedigree.[8] When a product
passes through the supply chain, any organization
handling the product shall have all of the details of
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 Sohini Kandar and H. V. Gangadharappa
the prior e-pedigree. When it hits the final destination,
the seller will have a full chart detailing the location
of the delivery shipment and the person managed
the contents. An e-pedigree is specifically designed
for the protection of consumers from harmful or
falsified medicines. Furthermore, e-pedigrees help
manufacturers for serializing down to the unit level
which can reduce recall costs and manage deliveries
more effectively.[10]
Usage of Machine-readable Data Carriers for
Drugs
Two-dimensional (2D) bar codes and/or radio-
frequency identification (RFID) tags are provided on
the primary, secondary, or tertiary packaging(s) or
pallets for determining an e-pedigree. Various types
of carriers can be chosen for different packaging
levels, such as the RFID tag or 2D bar code for the
distribution unit and RFID tags for cases and pallet
grade applications. For parenteral items, the details
can be applied directly to the container itself by
laser-etching 2D bar codes on the surface of the glass
or plastic container. If the 2D bar code is applied to the
container at the pharmaceutical plant, the product label
may contain details on the drug product. The insertion
of 2D barcodes on the surface of the container or the
label of the product at the pharmaceutical plant gives
details on the drug product. RFID tags are available on
or under the label of the product or on the container’s
cap or bottom. When a data carrier is attached to
the container closure system, it shall not affect the
health, identification, power, consistency, or pureness
of the product. Sometimes RFID tags can affect the
biopharmaceuticals because of the electromagnetic
emission. Therefore, 2D bar codes are used on the
biopharmaceuticals primary packaging as it does not
include emission of electromagnetic waves.[8]
Overcoming Illegal Drugs on the Internet
Legal online pharmacy sites offer customers a
convenient and private means of purchasing drug
products, but a range of illegitimate sites claim to
be legitimate sell low cost licensed and unlicensed
prescription and herbal drugs. Many patients use illicit
Internet pharmacy not only to cut costs but also to
escape getting a licensed doctor’s valid prescription.
Items sold by illicit Internet pharmacies pose a range
of health risks. Listed online pharmacies must follow
the National Association of Boards of Pharmacy
(NABP) approval requirements for federal and state
legislation. The following are classified as legal
websites for online pharmacy:
• The doctor’s prescription is requested normally by
e-mail, (if the doctor approves fax, the approved
doctor will also be asked to confirm the prescription)
• A telephone number or physical address is given
• A thorough medical history is required
1114
• Billing, confidentiality, and shipping charges are
clearly mentioned on websites
• Stable and authenticated website links are used for
payment.
Illegitimate websites for online pharmacy are as
follows:
• Postal address or telephone number are not given
• Rates substantially lower than the competitive prices
are offered
• A prescription is not needed for prescription drugs
or give access to faulty prescriptions
• Non-FDA licensed prescription pharmaceutical
products are sold
• Are included in the list of internet pharmacies on
the NABP’s “Not Recommended Sites.”[8]
WORLD WIDE PICTURE OF GDP
WHO[11]
WHO published a guideline on GDP, WHO GDPs
for pharmaceutical products in 2010 technical report
no 957, Annex 5. This guidance can apply equally
to human products and to veterinary applications, in
compliance with regional and national pharmaceutical
regulations. The guidelines also include for which the
patient needs a prescription and products that can be
distributed without a prescription. It is also applicable
to biologics and vaccines.
European Commission[12]
On March 7, 2013, the latest guideline on GDP was
finalized and issued by the European Commission.
It substitutes the existing GDP guidance issued in
1994 (94/C 63/03) and applies to wholesalers and
pharmaceutical companies, as well as to the unique
criteria for pharmaceutical dealers. On September 8,
2013, their specifications (Ref: 2013/C 68/01) came
into effect.
India[12]
Draft guidelines for GDPs of pharmaceutical products
for public opinion were published in January 2013
by the Central Drugs Quality Control Organization
of India, the authority of country’s medical products.
The purpose of these recommendations is to assure
the quality and identity of pharmaceutical products
during the distribution process. Such aspects comprise
procurement, manufacturing, storage, distribution,
transport, documentation, and record-keeping.
Canada[12]
In 2013, Health Canada initiates its 3-year upgrade
process of the standards for Drug Products during
Temperature Regulation in Storage and Transport
(GUI-0069). The new recommendations of Health
Canada, GUI-0069, came into force on April 28, 2011.
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 Sohini Kandar and H. V. Gangadharappa
USA
The chapter <1079> Good Storage and Distribution
Practices for Drug Products offered specific
guidelines on good distribution and storage practices
to guarantee that the quality of the drugs remains
unaffected when the end-user receives it.[12] The forum
of US Pharmacopeia introduced a new chapter <1083>
GDPs – supply chain integrity, which substitutes the
chapter <1079>. The new chapter mainly focuses on
counterfeit medicines.[13] This chapter outlines a range
of best strategies for maintaining the quality of the
supply chain for drug components (active substances
and excipients) and medicinal products.[8]
Singapore[12]
Singapore – Health Sciences Authority (HSA)
guidance notes on GDP. The HSA of Singapore
published guidelines for GDPs in August 2010.
This guide is intended for the storage, transport, and
distribution of the starting materials and medicinal
goods. This guide refers to all stages of the supply/
delivery chain. The aim of the guide is to ensure that
product quality and integrity are sustained throughout
the supply chain.
Brazil[12]
On 4 April, Brazil’s National Health Monitoring
Agency (Anvisa) started a consultation to recommend
the creation of an electronic drug tracking network,
from the point of development to the point of
dispensing. The introduced monitoring device shall be
based on the data matrix, a 2D barcode used in sales
packets and secondary packaging such as pill packs
and hospital parquets.
CHAPTERS OF GDP AS PER
EUROPEAN COMMISSION
According to the European commission, GDPs have
ten following chapters.
Chapter 1 – Quality Management
Quality management defines the Principe, quality
system, including management review and monitoring,
handling of outsourced actions, and management of
risk.[14] Deviations have to be examined and the CAPA
mechanism is applied as a preventive measure.[12]
Chapter 2 – Personnel
This chapter addresses the roles and responsibilities
of the individual responsible and other main staff.
Further information on training and hygiene is given
in the chapter.[15]
Chapter 3 – Premises and Equipment
It poses new storage area requirements. Temperature
mapping should involve initial mapping before use
Drug Invention Today | Vol 13 • Issue 7 • 2020
and seasonal changes, which should be repeated on the
basis of risk analysis.[12] There is definitely a variation
in the regulations for the use and the handling of
sensitive items such as radioactive and flammable
materials.[15] This chapter also includes a computerized
system, temperature, and environment control and
qualification and validation of equipment.[14]
Chapter 4 – Documentation
Good documentation is an integral element of the
quality system. Written reports would avoid errors in
communication and allow the follow-up of appropriate
medicinal product distributors. The documents
must be understood by the customer and operator
for procedures, and focus should be put on updated
documentation.[16]
Chapter 5 – Operations
More specific instructions about the qualification of
consumer and distributor, storage, destruction, pick-up,
supply, and exportation of the product to other countries
can be found in this chapter.[14] The “first in first out”
principle was substituted by a “first expired first out in,”
which is now the new definition for storage.[15]
Chapter 6 – Complaints, Returns, Suspected
Falsified Medicinal Products, and Medicinal
Product Recalls
All grievances, returns, reported fraudulent medication,
and recalls must be registered and treated in writing.
The responsible authorities will have access to
documents. Until clearance for resale, an evaluation of
the medicinal products that have been returned should
be performed. The new guidance indicates that the 10-
day time limit for returning medications outside the
authorized chain may be appropriate.[16]
Chapter 7 – Outsourced Activities
Any outsourced operation covered by the GDP
guideline must be properly described, accepted, and
monitored to prevent misconceptions that can impact
the product’s credibility. The giver of the contract
and the receiver of the contract must enter into a
written agreement that clearly sets out each party’s
responsibilities.[14] Contract criteria between parties
in which GDP is outsourced are very evident. As part
of the management analysis, the reported activities
would be verified.[16]
Chapter 8 – Self-inspection
Self-inspections are carried out to monitor and comply
with the concepts of GDP and to recommend appropriate
corrective action.[14] Personnel apart from responsible
personnel may perform self-inspections. An unbiased
external audit should be conducted. The findings should
be regulated by the principles of CAPA.[16]
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 Sohini Kandar and H. V. Gangadharappa
Chapter 9 – Transportation
The wholesale supplier is responsible for securing
drugs from breaking, adulteration, and theft and
ensuring that temperature is retained within acceptable
limits throughout transportation. Irrespective of the
mode of transportation, it should be possible to prove
that the drugs were not subjected to the conditions
which can affect their efficiency and integrity. A risk-
based strategy can be used for transport planning.[14]
This chapter has very detailed instructions and a few
changes. For example, items in a warehouse cannot
be kept more than 24 h. If the transportation does
not occur within this time period, the property would
be considered a storage facility and must be given a
delivery authorization for wholesalers.[15]
Chapter 10 – Specific Provisions for Brokers
This chapter explains the roles of the broker. Brokers
are not protected by property laws because they do
not manage the products they buy and sell directly.
However, they need a quality management program
and must be accountable for appropriate training
of their employees – as far as falsified drugs are
concerned. This chapter also includes a standard
operating procedure list to comply with by a dealer.[15]
Chapter 11 – Final Provisions
These guidelines substitute the GDP guidelines of
medicinal products for human drugs, published on
March 1, 1994 and the GDP guidelines for human use
for drugs published on March 7, 2013.[14]
CONCLUSION
GDP ensure that the sold goods have been approved
under the applicable regulations. Adequate conditions
for storage, including the transfer of goods between
different parts of the network for distribution, must
always be maintained. Contamination of drugs by other
medicinal products is prevented and goods are kept in
a clean and secure environment in the supply chain.
Apart from that, GDP also opposes the counterfeiting
of drugs and helps to identify the defective drugs and
recalled them as per regulations. As a result, more
emphasis has been imposed to cGDP. Therefore, the
management of the pharmaceutical distribution chain
needs to continuously update procurement activities
with an organized network.
ACKNOWLEDGMENT
I would like to convey my deep gratitude to the Principal
and Head of the Department of Pharmaceutics,
JSS College of Pharmacy, JSS Academy of Higher
1116
Education and Research, Mysuru, for constant support
and encouragement.
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Source of support: Nil; Conflicts of interest: None Declared
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