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Are You Up To Speed On The FDA's New Regulation On Supply Chain Integrity

May 16th, 2014 by Henry Macartney

FDA Supply Chain IntegrityThe Division of the Supply Chain Integrity of the FDA has two main goals, which are:

  1. Reducing the likelihood that unsafe, ineffective, and poor quality drugs will enter the supply chain and reach consumers.
  2. Raising public awareness of drug security threats and vulnerabilities in the supply chain.

These goals stem from the Drug Supply Chain Security Act (DSCSA) Title II of the Drug Quality and Security Act of 2013 in which the following points are to be implemented:

  • Product identification
  • Product tracing
  • Product verification
  • Detection and response
  • Notification
  • Wholesaler licensing
  • Third party logistics provider licensing

The law requires FDA to develop standards, guidance documents, together with numerous other activities and efforts necessary to support efficient and effective implementation of the new legislation. FDA has developed an initial schedule for implementing the law’s requirements (see below).

Standards Set for Prescription Drugs

The Drug Quality and Security Act amends the Federal Food Drug and Cosmetic act to address issues relating to the oversight of the practice of drug compounding and incorporates a traceability system which includes standards for prescription drugs. These standards may also be interpreted as being relevant for the medical device industry, who may act as suppliers to the pharmaceutical industry for particular products.

It establishes a category of “outsourcing facilities” under which third party suppliers may register to become subject to oversight by the FDA.

Implementing the New Regulations

The FDA has begun the implementation process with the release of several guidance documents:

The FDA has also provided an implementation plan, which is shown below:

FDA Implementation Plan

Maintaining Integrity Throughout The Product Lifecycle

It is of key importance that the quality and integrity of pharmaceutical and medical device products is maintained throughout the whole of the supply chain management activities during the distribution of these products to the end user of those products. This is governed through the Good Distribution Practice (GDP) methods, which forms an integral part of Good Manufacturing Practices (GMP).

Through the advent of the global pharmaceutical and medical device distribution networks these standards are becoming increasingly important. Such practices also help avoid and prevent falsified medical products from entering the legal supply chain.

Furthermore, QSIT (Quality Systems Inspection Technique – a public guide applicable to the Medical Device Industry used by the FDA for their inspections) requires not only that software and hardware used in medical devices be validated, but also that the above-mentioned entities are monitored for any form of deviations at any time during the life-cycle of these components. This means that the supply chain integrity of the medical device components must be carefully monitored during the life-cycle of the medical device.

In order to understand the consequences and dimensions of the new DSCSA for supply chain management and GDP, the experts from GxP-CC can help you evolve a strategy to meet your needs and those of your clients.




Posted in Drug Quality and Security Act of 2013, FDA & European Regulations, FDA Supply Chain Integrity Regulations, GDP, GMP, GxP CC, Hardware Validation, QSIT, Software Validation, the Drug Supply Chain Security Act (DSCSA) Title I

About this author:

Henry Macartney

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