Computer Systems in China - to Validate or Not?

At today's Computer System Compliance session at the ISPE-CCPIE conference in Beijing we considered the new draft SFDA GMP regulations and the requirements (or not) to validate computer systems.

As blogged yesterday, the Chinese State FDA (SFDA) are committed to improving compliance, but the current draft of the new Chinese GMP regulations are ambiguous with respect to computer systems validation.

While certain Articles and Annexes infer a need to validate, calibrate etc certain control and monitoring systems there is no equivalent to US 21 CFR211 subpart 68 or PIC/S / EU Annex 11, which states a clear requirement to validate computer systems.

Some would claim that this is deliberate ambiguity on the part of SFDA and that it suits them to provide some 'wriggle room' for Chinese manufactures, but more likely is that computerized systems have been of relatively low priority. Re-writing and updating the GMP regulations is a significant undertaking and it is only reasonable that focus is given to basic GMP, especially when China is only just catching up with more developed countries with respect to the use of computer systems and there is no history and significant risk to patients as a result of failure to validate a computer system.

However, this ambiguity does not meet the stated aim of SFDA, which is to generally align national GMP regulations with World Health Organizations (WHO) guidelines. WHO guidelines (WHO Technical Report Series 937, 2006: WHO Expert Committee on Specifications for Pharmaceutical Preparations, Appendix 5) clearly have a requirement to validate computer systems, and this does appear to be missing from the current draft of the SFDA regulations.

There is also a view that SFDA want to limit the costs they are imposing on their local manufacturers at a time when the Chinese government is looking to reduce the cost of drugs and devices while at the same time as it is looking to provide healthcare to 900 million people.

However, if SFDA is serious about building a risk-based approach into the new GMP regulations it is perfectly feasible to include a clear requirement to validate computer systems while leveraging a cost effective risk-based approach which will limit the costs involved in computer systems validation according to risk.

Unless this is included in the new regulations Chinese companies face the prospect of a two tier approach to computer system validation depending on whether products are intended for the domestic or export market. This would be confusing, limit flexible operations and potentially cause problems where Enterprise Systems support domestic and export operations.

Let's hope that SFDA take on-board the need to align with international regulations in this regard and revise the current draft regulations to provide the clarity that the Chinese Life Sciences industry is looking for with respect to computer system validation.