Good Distribution Practices
Good Distribution Practices
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.
Manufacturer warehouses
Contractor warehouses
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 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.
Drugs at risk from freezing or elevated temperatures (vaccines, insulin, and biological
products)
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