EFCG Calls for Inspections of API Manufacturers
The European Fine Chemicals Group has proposed that mandatory inspections be introduced for all global API manufacturers wishing to supply the European Union market.
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.
The Future of Cleanroom Construction: How Hybrid Solutions are Changing the Game
May 14th 2025Imagine a world where cleanroom facilities—essential for pharmaceutical manufacturing, biotechnology, and high-tech industries—are built with unparalleled speed, precision, and efficiency. That world is here, thanks to the hybrid construction approach. By blending traditional stick-built methods with modular and prefabricated solutions, companies are overcoming the limitations of conventional construction while ensuring compliance with stringent industry regulations. In this interview, we explore how hybrid cleanroom construction is transforming the industry, offering faster project timelines, improved quality control, and significant cost advantages. Join us as we delve into this game-changing approach with industry experts who are leading the charge in revolutionizing cleanroom infrastructure.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
Biophysical and Aggregate Characterization for the Development of Biologics
June 10th 2025This eBook explores how advanced particle analysis technologies are revolutionizing biologic drug development. It highlights the importance of accurately identifying and characterizing subvisible particles to ensure drug safety, stability, and regulatory compliance. Techniques like Backgrounded Membrane Imaging (BMI) and Fluorescence Membrane Microscopy (FMM) are often used for their capabilities in detecting protein aggregates and degraded excipients such as polysorbates. Case studies and experimental results demonstrate how these tools provide high-throughput, low-volume analysis that enhances decision-making in formulation screening and manufacturing.
Psilera, Hesperos Agree to Accelerate Organ-on-a-Chip Treatment for Frontotemporal Dementia
June 9th 2025The partnership leverages the Hesperos organ-on-a-chip platform in the preclinical development of Psilera’s lead compound targeting the progressive neurological disorder for which treatment options are few.
