Good Distribution Practices

Introduction
Distribution is an important activity in the integrated supply-chain management (SCM) of
pharmaceutical products. Various people and entities are generally responsible for the handling,
storage and distribution of such products. In some cases, however, a person or entity is only
involved in and responsible for certain elements of the distribution process. The objective of
these guidelines is to assist in ensuring the quality and identity of pharmaceutical products during
all aspects of the distribution process. These aspects include, but are not limited to, procurement,
purchasing, storage, distribution, transportation, repackaging, relabeling, documentation and
record-keeping practices. The storage, sale and distribution of pharmaceutical products are often
carried out by various companies, institutions and individuals.
Good Distribution Practice (GDP) is defined as is the part of quality assurance which ensures
products are consistently stored, transported and handled under suitable conditions as required by
the marketing authorization (MA) or product specification.
With increasing regulatory scrutiny pharmaceutical supply chain stakeholders must focus their
efforts on meeting the requirements of storage, transport and handling of time and temperature-
sensitive products. However there are many factors to consider the temperature controlled
distribution 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.
USP Good Distribution Practices (GDP)
U.S. Pharmacopeia (USP) is a key source for pharmaceutical Good Distribution Practices (GDP)
applicable to all people and organizations involved in any aspect of the storage and distribution
of pharmaceutical products – from the receipt of raw materials at manufacturing plants to the
final shipment of finished drugs to the end user including but not limited to the following:

o Manufacturers of drug products for human use such as all active pharmaceutical
ingredients, drug products, radiopharmaceuticals, packaging materials, dietary
supplements, biological and biotechnological products, and cell and gene therapy
products
o Laboratory operations
o Distribution companies involved in automobile, rail, sea, and air services
o Mail distributors including the U.S. Postal Service (USPS) and other expedited shipping
services
o Retail, compounding, specialty, mail order, hospital, and nursing home pharmacies.
o Packaging operations by the manufacturer or a designated contractor for the Product
Registration Holder.
o Repackaging operations in which the products/cosmetics may be owned by an
organization other than the primary manufacturer.
o Pharmacies including but not limited to retail, compounding and hospital.
o Importers and exporters.
o Wholesale distributors.
o Distribution organizations involved in road, rail, sea and/or air services.
o Third-party and fourth-party logistics providers, brokers and freight forwarders.
o Health care professionals storing products prior to dispensing or administering to
patients.

Temperature
Control
Management
(TCM)

GDP
Distributionn Good Impot
Control Practiices
System (DCS) (GIPs)
Quality Management Systems (QMS)
USP provides recommendations for a quality management system (QMS) that is the foundation
of a good GDP program. A robust QMS includes several sub-systems for managing risk,
documentation, storage, transport, and temperature. A QMS acts as the architecture of GDP. First
and foremost, it should build on the foundations of the FDA's CGMP. Beyond that, it should be
tailored to the specific needs of your operation, and at most, aspire for excellence, rather than
mere competence.
There’s no point in adopting processes and procedures related to GDP without putting a QMS in
place. All it takes is a single company to neglect implementing a formal system to measure and
monitor processes and procedures, to put at risk the efficiency, integrity and cost-effectiveness of
the entire supply chain.
FDA Current Good Manufacturing Practices (CGMP)
The Food and Drug Administration’s main regulatory standard ensuring quality is the Current
Good Manufacturing Practices (CGMP) regulation for human pharmaceuticals. These
regulations appear in several parts of Title 21 in the Code of Federal Regulations (CFR), which
interprets the Federal Food, Drug, and Cosmetic Act and related statutes. The FDA carefully
monitors compliance with CGMP minimum requirements for the methods, facilities, and
controls used in manufacturing, processing, packing, and distributing drug products. Adherence
to the regulations ensures the identity, strength, quality, and purity of drugs by requiring that all
stakeholders along the supply chain adequately control their operations.
According to the FDA, pharmaceutical distribution best practices start with a quality
management system to prevent instances of contamination, mix-ups, deviations, failures, and
errors. These formal controls help to ensure that drug products meet FDA quality standards.
Keep in mind that CGMP regulations are the minimum requirement.

General Principles of GDP

 All parties involved in the distribution of pharmaceutical products have a responsibility to

ensure that the quality of pharmaceutical products and the integrity of the distribution
chain is maintained throughout the distribution process from the site of the manufacturer
 to the entity responsible for dispensing or providing the product to the patient or his or
her agent.
 The principles of GDP should be included in national legislation and guidelines for the
distribution of pharmaceutical products, in a country or region as applicable, as a means
of establishing minimum standards.
 The principles of GDP are applicable both to pharmaceutical products moving forward in
the distribution chain from the manufacturer to the entity responsible for dispensing or
providing pharmaceutical products to the patient and to products which are moving
backwards in the chain, for example, as a result of the return or recall thereof.
 The principles of GDP should also be adhered to in the case of pharmaceutical products
which are donated.
 All entities involved in the distribution process should apply due diligence with
adherence to the principles of GDP, for example, in procedures relating to traceability
and in recognition of security risks.
 There should be collaboration between all parties including governments, customs
agencies, law enforcement agencies, regulatory authorities, manufacturers, distributors
and entities responsible for the supply of pharmaceutical products to patients to ensure
the quality and safety of pharmaceutical products and prevent the exposure of patients to
counterfeit pharmaceutical products.
Regulation of the distribution of pharmaceutical products
1. National legislation should be in place to regulate the activities of persons or entities
involved in the distribution of pharmaceutical products.
2. The distributor or the organization to which the distributor belongs should be an entity
that is appropriately authorized in terms of applicable legislation to perform the
function(s) that it intends to perform. The distributor or the organization to which it
belongs should be held accountable for the activities that it performs which relate to the
distribution of pharmaceutical products.
3. Only persons or entities which are authorized to do so and/or which hold the appropriate
license should be entitled to import or export pharmaceutical products.
 4. Distributors or their agents may only distribute a pharmaceutical product within or to a
country or territory if a marketing authorization or similar authorization has been
granted, which allows the use of that pharmaceutical product in that country or territory.
5. Holders of an authorization to distribute pharmaceutical products should obtain their
supplies of pharmaceutical products only from persons or entities which are in
possession of the applicable authorization to sell or supply such products to a distributor.
6. Distributors or their agents should supply pharmaceutical products only to persons or
entities which are themselves authorized to acquire such products either in terms of an
authorization to act as a distributor or to sell or supply products directly to a patient or to
his or her agent.
7. Some duties and responsibilities may be delegated or contracted out to suitably
designated persons or entities as authorized and as necessary. Duties and responsibilities
may only be delegated to entities which are suitably authorized in line with the national
legislation. Duties and responsibilities should be specified in a written agreement. There
should be no gaps or unexplained overlaps with regard to the application of GDP. These
delegated and contracted out activities should be documented in agreements or contracts.
There should be a periodic audit of such activities with regard to application of GDP.
8. If a distributor or his or her agent subcontracts an activity to another entity, the person or
entity to which the activity is subcontracted must be appropriately authorized to perform
the subcontracted activity and should uphold the same standards as the distributor.
9. The sale of pharmaceutical products via the Internet should be limited to registered and
authorized mail-order pharmacies or other authorized entities.
Storage Management
Good storage management identifies all of the facilities requiring the implementation of adequate
controls for drug storage, including

 Manufacturer warehouses

 Contractor warehouses

 Wholesale distribution warehouses

  Mail order or retail pharmacy storage areas

 Hospital or nursing home pharmacy storage areas

 Border Customs storage areas

For each of these locations, one or all of the following processes should be accounted for
depending on the facility’s specific operations:

 Receiving: bringing a drug product into a facility

 Transferring: moving a drug product internally within a facility or into or out of a vehicle

 Storing and holding: maintaining temporary possession of a drug product in the supply
chain process, during which no movement of the product will occur

Storage in Buildings and Facilities

Buildings and facilities used for warehousing, storage, and holding of drug products should
conform to the following standards:

 Drug product temperatures must be maintained as defined on the product label.

 Storage areas should be of adequate size for their intended use to prevent overcrowding.

 The facility should be designed to control environmental conditions where necessary and
be easy to clean.

 Storage should provide for the segregation of approved, quarantined, rejected, returned,
or recalled drug products.

Receiving and Transferring Drug Products

Storage includes time spent at the receiving bay area, where products can quickly react to
ambient conditions. When drug products arrive at the warehouse loading docks, they should be
transferred immediately to a designated storage environment to ensure minimal time outside
specified storage conditions. Receiving docks should also be clean and protect deliveries from
inclement weather during unloading.
Refrigerators and Freezers
Refrigerators and freezers used to store drug products must maintain temperatures defined on the
product label. Typically, a refrigeration unit specification is set to 5° with an allowable range of
±3° to store products labeled 2°–8°. Freezer temperatures may vary and typically range from
−25° to −10°.
Products should be organized in refrigerator and freezer units to allow adequate air flow between
them. The units themselves should be positioned in the facility so that they’re not subjected to
environmental extremes of heat or cold that could affect their performance. In large commercial
units such as walk-in cold rooms, a suitable number of temperature-recording devices should be
installed to record and monitor temperatures. Each smaller unit should use digital devices to log
and track temperatures within its interior.
Risks Management
Ensuring the organization’s best interests are served by adhering to proper practices, controls,
and procedures, including but not limited to:

 The nature of your drug products

 Distribution requirements on the container label

 Incidents of exposure to adverse environmental conditions

 Number of stages and receipts in the supply chain

 Manufacturer’s written instructions

 Drugs at risk from freezing or elevated temperatures (vaccines, insulin, and biological
products)

Examples of common risks include:

 Temperature excursions that cause melting or freezing

 Loss of container integrity during transit

  Exposure to humidity leading to product degradation

Transportation Management
Transport is the movement within the supply chain between distribution facilities by trucks,
trains, aircraft, sea vessels, mail delivery vehicles, emergency medical vehicles, and industry
representative automobiles. Communication within the supply chain should be coordinated to
determine proper timing for drug products to be transported and received, taking into account
holiday schedules, weekends, and other forms of interruption.
Pharmaceutical manufacturers should use packaging that best protects the drug product during
transport, taking into account seasonal temperature differences and the routes and modes of
transport. The type, size, location, and amount of temperature stabilizers required to protect the
product should be based on documented studies of specific distribution environments the drug
will encounter along the supply chain. Accordingly, environmental conditions should be
measured continuously with digital monitoring equipment.

Raw Material
Store

manufacturing
Plant

Central
Warehose

Distributors

Retailors

Pharmaceutical Distribution Process