Monday 27 January 2020

Integrating Good Distribution Practice into the QMS

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.

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:

Sandle, T. (2019) Integrating Good Distribution Practice into the QMS. In Schmitt, S. (Ed.) Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers, Volume 1, DHI/PDA Books, River Grove, IL, USA, pp241-272

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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