Print Edition - Warehousing and Shipping Supply Chain Quality Agreements: Key Considerations for Pharmaceutical Companies

December 2010
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To avoid FDA warning letters, it’s no longer enough to have purchasing agreements with shippers that make passing reference to quality contracts. You need ironclad supply chain quality agreements.

But what does a good quality agreement look like? How do you negotiate it with warehouses, wholesalers and shippers? And, then, how do you document compliance?

Here are the answers you need to “FDA-proof” your entire supply chain.

From FDAnews
Warehousing and Shipping Supply Chain Quality Agreements:
Key Considerations for Pharmaceutical Companies

This essential management report from FDAnews explains the regulatory supply chain requirements that govern pharmaceutical warehousing and transport.

Plus, you’ll find practical guidance you can use immediately to find — and fix — the kinds of supply chain quality “weak links” that are driving a recent spate of FDA citations, including:

  • Deficiencies in the receipt, storage and distribution of Rx drugs
  • Incorrect procedures for temperature excursion investigations or holding drugs out of their labeled storage conditions
  • Inadequate documentation to confirm that labeled storage conditions were maintained during transport
  • Inaccurate equipment calibration or insufficient temperature-monitoring equipment

Buy now to reduce your recall and warning letter risks with quality agreements designed to help your entire supply chain pass FDA muster, including how to:

  • Vet and review storage and warehouse vendors before you sign contracts
  • Create comprehensive quality agreements that spell out SOPs for the exact issues FDA inspectors are targeting
  • Negotiate with third-party suppliers to tie SOPs to contracts
  • Handle threat identification in cold chain transit and storage processes
  • Develop contingency plans for warehousing and transport supply chain processes
  • Apply lessons from case studies to avoid spoilage, contamination, and losses due to temperature variations

Don’t become part of the “upswing” in supply chain citations!  Get the regulatory understanding and practical guidance you need to safeguard compliance and your products.

Buy Now!
Warehousing and Shipping Supply Chain Quality Agreements is available in print or PDF format for $397. Act now: place your order here.

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