NMPA mock audit
More frequent and stricter inspections
China regulations have been dynamically changed. One of the impacts is that the China National Medical Products Administration (NMPA) increased overseas manufacturing site inspections in recent years. These are audits comparable to MDSAP, Notified Body and US FDA.
It is a potential risk to the foreign manufacturers if they are not aware of the gaps between China requirements and their own countries. Major non-conformity notice may lead to certificate suspension/cancellation. Manufacturers looking to market products in China must be prepared for potential visits from Chinese inspectors before or after placement.
Get prepared for the inspection
Mock-audits and trainings to get prepared for the China Health Authority inspection teams are important factors to consider for internal QMS management.
NMPA has performed quality system audits and good manufacturing practice (GMP) inspections for many years in China. According to regulations, overseas manufacturers are supposed to have the same level of compliance. With China’s government rapidly building up a professional inspection team, both domestic and overseas manufacturers are expected to receive more frequent and stricter inspections since 2018.
China intends to pick up this work as well in their rapid progression in the field of regulatory compliance and to ensure the imported products are safe for the Chinese population. The published regulation has adjusted international rules with details to be aligned with domestic practice, but there would continue to be some differences in practice.
Some advantages to the foreign manufacturer are:
1) Pre-notification will be given with more preparation time. The “double-blind” arrangements of unannounced inspections performed in China will be very difficult to implement for overseas inspections due to the need for visa applications and logistic arrangements.
2) Make good use of a translator as a buffer to precisely understand the questions and prepare the answers.
3) Remotely auditing is becoming popular due to pandemics. May have several locations and front/back rooms coordinated together.
The inspections currently focus on large companies with big quantities sold, companies making high-risk and long-term implants, or companies that are reported with suspected flawed products. With time passing, the scope might be further widening, and many more companies are and will be subject to overseas inspections.
A pre-gap assessment between China GMP against ISO13485 and some knowledge of inspection will help the manufacturers better prepare for the authority audit.