DRUG DISTRIBUTION TEMPERATURE CONTROL INITIATIVES
This article was originally published in The Gold Sheet
Executive Summary
...by industry and regulators are heading toward internationally harmonized solutions to the challenges involved. In view of more temperature-sensitive products and a more complex distribution chain, FDA and other regulatory agencies are working to develop and implement effective guidance and oversight in conjunction with industry and pharmacopeia efforts to develop viable, globally-relevant standards. Key temperature control issues include: ** how much monitoring is appropriate ** allowable excursions during transportation, and ** how to qualify the distribution process. [A discussion by an FDA compliance official of the initiative under way at the agency to assess cold chain problems and better target its regulatory response is provided.]
You may also be interested in...
ICH M7 Guide Sets Validation Principles For Genotoxicity Impurity Testing For New Drugs
The US FDA has issued a draft question and answer document to the ICH M7 guideline that sheds some light on the validation that needs to be performed before manufactures can rely on the results of computational tests in assessing genotoxic impurities of new drugs.
McKinsey Survey Highlights Progress, Challenges in Adoption of QbD
Drug manufacturers are adopting QbD but there are exceptions, especially among some generics firms, McKinsey finds in industry survey. The top challenge to further adoption: misalignment between R&D and commercial operations. Second is a lack of belief in the business case. However, the cost turns out to be low and the financial reward high, McKinsey says.
Manufacturers Encouraged to Enhance Clinical Relevance of Quality With QbD
Using QbD to set specs that make a difference to patients is hard but important work, FDA's Woodcock says. Prasugrel, levothyroxine, pallodone examples explored. How to establish a 'work space.' How to make the right correlations.