Charting US measures
In the US, later this month (July 12, 2013), FDA will hold a day-long public meeting to discuss how to implement the drug
supply-chain provisions found in Title VII of the Food and Drug Administration Safety and Innovation Act of 2012. Title VII
gave FDA new authorities to address the challenges posed by an increasingly global drug supply chain. According to FDA, 40%
of finished drugs are imported, and nearly 80% of active ingredients come from overseas sources (6).
The purpose of the July 12th meeting is to provide an overview of Title VII, discuss how FDA plans to implement it, and hear
public comment about those provisions that specifically address imported drugs and importers. Under Title VII, FDA is authorized
to require that importers submit information demonstrating that their drug complies with applicable requirements of the Federal
Food, Drug and Cosmetic Act before their products can enter the US. In addition, commercial importers must register with FDA
and meet good importer practices (6).
Focus on Excipients
Another key milestone this month is the end of the public comment period for FDA's draft guidance, Contract Manufacturing Arrangements for Drugs: Quality Agreements. The draft guidance, which was issued in May 2013, describes the agency's current thinking on defining, establishing, and documenting
the responsibilities of parties involved in contract cGMP manufacturing of drugs. Public comment on the draft guidance is
open until July 29, 2013 (7).
The draft guidance describes how parties involved in contract manufacturing of drugs can use quality agreements to delineate
their responsibilities and ensure drug quality, safety, and efficacy. The guidance applies to the commercial manufacturing
of APIs (drug substances or their intermediates), finished drug products, combination products, and biological drug products.
The draft guidance describes how contract manufacturing operations fit within the larger scheme of pharmaceutical quality
systems. FDA says the draft guidance incorporates provisions from ICH guidelines, including ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, ICH Q9 Quality Risk Management, and ICH Q10 Pharmaceutical Quality Systems (7–10). The draft guidance notes that although written quality agreements are not explicitly required under existing cGMP,
owners and contracted facilities can draw on quality-management principles to carry out the complicated process of contract
drug manufacturing by defining, establishing, and documenting the responsibilities of all parties involved in drug manufacturing,
testing, or other support operations. Accordingly, FDA recommends that owners and contracted facilities implement written
quality agreements as a tool to delineate responsibilities to ensure the quality, safety, and effectiveness of drug products.