Quality Systems in Asia
As Asia has become the world's factory, proper quality assurance (QA), quality control (QC), and quality management systems (QMS) are keys to sourcing, manufacturing and registering your products there. Your quality system must be airtight to keep out defective products, especially in low-cost countries like China, India, and Vietnam. To guarantee medical product quality, necessary measures may include doing an audit at your Asian factory/supplier, sending a company representative to the factory during the production run; training local QA employees on Western quality standards; or having an independent lab test products for quality after they leave the factory.
Keep in mind that local Asian quality or GMP standards may not be the same standards as in the West. Chinese GMP is different from Japan drug GMP or medical device QMS. What documents are required and what CAPA is appropriate will differ according to the country's regulations.
In addition, local Asian manufacturers often claim they adhere to international standards (ISO 9001, ISO 13485, CFR 820, etc.), but actually may not meet these standards in practice. PBM can help by providing the stringent due diligence and compliance auditing you require to qualify facilities in Asia.
In more advanced countries like Japan, you may also need assistance to comply with their complex quality management systems and requirements to register and market your products there.
PBM has people in each Asian country that can do FDA audits. We do not need to fly in experts from the U.S.
Click on the countries below for more information on quality standards in each Asian country and/or contact us to discuss your specific needs.