Good Distribution Practice (GDP) concerns the
distribution processes for pharmaceutical products that results in medics and
patients obtaining access to the medications required. For the pharmaceutical
organization, the distribution process occurs both upstream and downstream.
Upstream are the suppliers who create goods and services used in a
manufacturer’s own operations, such as raw components or materials. The
downstream supply chain efficiently distributes a company’s products or
services to its customers. Each stage, both upstream and downstream, needs to
be proactively managed to minimize quality, as well as financial,
confidentiality, operational, reputational and legal risks.
Tim Sandle has written a chapter for the book GoodDistribution Practice: A Handbook for Healthcare Manufacturers and Suppliers.
Here is an extract:
These distribution processes concern supply chain,
including cold supply chains (where required), and the tracking and tracing of
medicines. Traceability includes ensuring that the required environmental
controls are met, and that tampering or fraudulent activities are avoided, to
the level that each induvial item can be traced from the completion of
manufacture to its arrival with the end user (Marucheck et al, 2011). The
distribution network for medicinal products is invariably complex and it involves
many different parties at different stages. In addition to the challenges
associated with this complexity and with protecting the product from being
affected by environmental conditions, damage, or loss, there is also a threat
from criminal activities centered on seeking to introduce falsified medicines
into the supply chain (Bruinsma, and Bernasco, 2004).
GDP requirements are designed to codify and to
structure the processes. These requirements bear close similarity to the
requirements set out in Good Manufacturing Practice (GMP) regulations. The
primary difference is that GDP covers the wholesale distribution of medicines,
whereas GMP covers their manufacture.
There overlap between the two rest with the need to maintain product
quality after a batch has been released from the manufacturing site, as well as
the necessity to monitor and control complaints, address problems, and have a
system in place to enact a recall.
In assessing the requirements for GDP, there are
different national and supranational standards. In the US GMP is based on the
Code of Federal Regulations 21 CFR 210/211, with additional guidance contained
within USP chapter 1079 “Good Storage and Distribution Practices for Drug
Products.” (USP, 2018) There is an additional USP chapter of interest, chapter
1197 “Good Distribution Practices for Pharmaceutical Excipients” (USP, 2018b).
For Europe GDP is based on the Directive of the Board of the European Community
92/25/EEC regarding the wholesale distribution of drugs for human consumption,
supported by guideline 2015/C 95/01 (European Commission, 2015), and the
Falsified Medicines Directive (European Commission, 2011), which requires a
unique identifier and an anti-tampering device to allow the verification of the
authenticity of medicinal products. With the World Health Organization, the
applicable text is Annex 5 of the WHO recommendations “good distribution
practices for pharmaceutical products.” (WHO, 2010a) One commonality through
these regulations and following on from items raised during pharmaceutical
organization inspections, is with a focus on serialization. This has required
for new strategies, processes, and technologies that allow for a business to,
at any time, pinpoint the location and origin of any single drug.
A weak GDP system is one where there is a key
disconnect between the manufacturer and the process that occurs once the
product leaves the facility (Rees, 2013). An overarching area of regulatory
concern is with the effectiveness of the incorporation of GDP into the Quality
Management System (QMS), a system that applies for both wholesaler and broker.
This chapter looks at Quality Risk Management in relation to GDP, covering
areas like good distribution principles, the necessity of having Quality
Technical Agreements in place, and measures to take appropriate corrective and
preventative actions should deviations occur.
The reference is:
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
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