EFCG Calls for Inspections of API Manufacturers - - BioPharm International

ADVERTISEMENT

EFCG Calls for Inspections of API Manufacturers



The European Fine Chemicals Group (EFCG) has proposed that mandatory inspections be introduced for all global API manufacturers wishing to supply the EU market. EFCG believes that such inspections will help to harmonize the global rules and regulations concerning APIs and pharmaceutical products.

The group proposes that inspections be conducted using a Mutual Recognition Agreement (MRA) approach involving national regulatory authorities sharing inspection resources. An EFCG position paper estimates that the cost of inspections will be approximately EUR 2.6 million ($3.3 million) over a three-year period and suggests that financial resources could come from participating companies wishing to sell their APIs in the EU marketplace.  

During the past decade, the market for generic APIs has increased and a greater number of APIs used in European medicines are sourced from China and India. API manufacturers in these countries, however, are rarely inspected by EU authorities. In a position paper, EFCG claims that 70% of all APIs consumed in Europe are imported from China and India. With the vast majority of manufacturers unregulated, some APIs may contain impurities or may be in breach of EU quality standards. Cases cited by the position paper include glycerine contaminated with antifreeze (2006), heparin contaminated with chondroitin sulphate (2008) and contaminated cardiovascular drugs in Pakistan (2012).

Assuming 860 API manufacturing sites were inspected once every three years by 33 inspection authorities (EU (27), USA, Australia, Japan, Switzerland, new Zealand, Canada) to the same standard (ICH Q7) and that they are willing and able to share the inspection outcomes, then around 8 sites need to be inspected each year by each inspection authority, states the position paper.

EFCG has been calling for mandatory inspections of all global API sites since 2004.

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

Compounding Pharmacy Issues Recall, But Challenges FDA Decision
July 22, 2014
AbbVie's Acquisition of Shire Could Save $8 Billion in Taxes
July 21, 2014
AbbVie to Acquire Shire for $54.7 Billion
July 18, 2014
AstraZeneca Reveals Design for New Global R&D Center and Corporate Headquarters
July 18, 2014
Particulate Matter Prompts Baxter's Recall of IV Solutions
July 17, 2014
Author Guidelines

Click here