Conducting good manufacturing practice (GMP) inspections of 10 production plants will give the Chinese State Food and Drug Administration (SFDA) an understanding of regulating overseas sites.
In the pilot programme the SFDA wants to inspect manufacturers of vaccines, biologics, APIs (active pharmaceutical ingredients) and solid oral dosage forms, Hua Zhang, GMP department head at the Shanghai FDA, said at AAPS 2011.
Inspecting different types of sites will help the SFDA develop its inspection procedures for overseas manufacturing facilities. The SFDA is enhancing its oversight of plants outside China at the same time as it tightens GMP regulations for domestic producers.
New GMPs adopted by the SFDA bring local standards closer to international practices but this will put pressure on many domestic manufacturers. The SFDA estimates 60 to 70 per cent of sterile sites will have to upgrade if they want to meet new GMP requirements, Hua said.
Some facilities will need “substantial” upgrades, Hua said, to comply with new cleanroom, process control and equipment GMPs. Hua said: “In the past some companies didn’t test microbial limits of raw materials or primary packaging materials. Now they are required to control the process from beginning to end.”
Companies must also have a “quality culture” and drop the speed and cost-focused practices that developed in the highly competitive market, Hua said. The SFDA expects Chinese companies to add staff with risk management and pharmaceutical quality systems experience to adapt to GMPs.
New facilities must comply with GMPs when they open but existing sites have time to adapt. The SFDA is allowing vaccine and injectables suppliers three years to comply, and manufacturers of certain products have until 2016. Hua said this transition will have long-term benefits for China.
“We expect [new GMPs] to increase the global competitiveness of our industry”, Hua said.