Medical Plastics News editor Laura Hughes sat down with Gert Bos, president-elect of the Regulatory Affairs Professionals Society (RAPS) to learn about how European medical manufacturers can best prepare for inspections in China.
Bos, who spoke recently at the RAPS Regulatory Conference in Brussels provided insight on these inspections which are conducted on behalf of the National Medical Products Administration (NMPA).
Put simply, what does the inspection process consist of?
The inspection is usually conducted by three or more inspectors from China’s inspection agency - the Centre for Food and Drug Inspection (CFDI), on behalf of the NMPA.
Additionally, back at the agency’s headquarters there is a larger team who are also involved in the process. The inspectors on site may contact these China-based team members during the inspection if any questions or issues arise.
During the inspection, the inspectors may take pictures, videos, or samples which will be shipped to China for further testing.
How are the inspections typically arranged?
The NMPA will provide the legal agent in China with notice and a rough timeline prior to the inspection. Following a discussion between NMPA and the manufacturer the inspection dates will be finalised.
What are the key aspects manufacturers should be aware of prior to inspection?
In order to optimally prepare for the inspection, it is vital for the manufacturer’s regulatory team to know and understand China’s regulations and standards to the best of their ability. Additionally, the inspection involves multiple departments to work together alongside the agent in China.
An important thing to note is that the inspections will be carried out in Chinese, and so it is important to have enough translators and moderators available onsite who are capable of translating the technical Chinese back and forth into your native language.
How do these inspections differ to other parts of the world?
Aside from the different regulations and standards, it is important to consider the different culture and expectations here. Additionally, the scale and focus of the inspection could differ from other regulators so it is vital to understand and know as much as possible about what will be required in advance of the inspection.
What are the major consequences of failing an inspection?
In the case of an inspection failure, NMPA will implement risk control measures which may include suspension and cancellation of the certificate, or a forced recall in serious cases. Failure could also result in fines for the company, and in some instances for the legal agent also.
Other consequences may include a responsible staff member not being permitted to work in a certain field in China for a five-year period – which in effect forces a career move to another sector.
In the instance that non-conformities occur and there are areas to be disputed, a statement or explanation must be provided within 10 working days after receiving the result notice from NMPA.
Following the implementation of any Corrective Action Preventive Action (CAPA), a CAPA progress report will need to be provided within 50 working days. Once all CAPA is completed, the manufacturer can apply for the risk control measures to be relieved.
Do you believe that advances in technology have helped to keep facilities operating at Good Manufacturing Pratice (GMP) standard levels?
Certainly, they have.
In GMP, a number of aspects have been facilitated over the years by technological improvements. A key part is the assistance provided by computers within production processes, quality assurance checks and verifications, and in ensuring the validation of consistent products and batches. Computers are able to improve the reliability of these processes, whilst playing key roles within elements such as security and access control to sites.
Of course, there problems could occur as people may attempt to hack into any control or protection system, and so any of these advancements come with a strong call for cybersecurity measures.