It’s been 20 years since Good Manufacturing Practices(GMP) was introduced in Korea in 1994. There have been much progress and developments in both external and internal aspects through many supplementation and revisions. Expecially, “new GMP” in 2008 has adopted major components of GMP such as validation, pre-approval inspection and annual product review, etc. Recently harmonization of Korea GMP regulation with PIC/S(Pharmaceutical Inspection Cooperation/Scheme) GMP guide is in the final stage.
In spite of these intensive development, there’s no denying that some deficiencies have been found in the compliance of GMP such as recent “recall of children’s antipyretic oral suspension”, which is the same situation in the other countries like US and EU. In other words, GMP which has been in operation for managing the production and quality by ICH(International Conference of Harmonization) countries and industries has been proven to be lack of potential(predictive) risk consideration during manufacturing and quality control process. As such, international regulatory authorities and industries have same position on establishment of continued monitoring system through lifecycle approach as well as proactive analysis and evaluation of risk in the base of quality by design(QbD).
In this circumstances other countries like US and EU has adopted new ICH quality guidelines since 2003 focusing on risk management through pharmaceutical lifecycle approach, while Korea has yet much to be desired to be at the level. Therefore, prompt and immediate adoption of QbD and QRM by domestic industry is necessary in the perspective of not only quality assurance but also market competitiveness of pharmaceuticals.
This study compared Korea GMP regulation and PIC/S GMP Guide article by article and analysed the differences. Also it analysed GMP regulation in terms of risk management and compared foreign systems and the contents. It referenced not only ICH　Q8, 9, 10 but also the regulations of ICH countries such as US, EU and Japan.
This study also performed survey to the government and industry employees in the purpose of diagnosing current domestic situation and the perception of QbD and QRM. It used chi-squared test(Fisher’s exact test) using statistics program SAS 9.2 version with the significance of p=0.05.
The result is as follows.
It suggested the necessary points to finalize the equivalence process with domestic GMP regulation and PIC/S GMP guide and the introduction of QbD and QRM.
First, it suggested that the way of adopting the principles of QbD and QRM for the purpose of international harmonization of GMP regulations. Second, it pointed that the most of the new GMP regulations shall be at the level of legal force for assuring the actual compliances.
Third, it suggested that the prompt measures be taken for the solution of those areas, both of non-GMP required area such as radiopharmaceuticals and medical gases, and the other areas with no separate GMP regulations such as API(Active Pharmaceutical Ingredients) and IMP(Investigational medicinal product).
Fourth, in the circumstances of the closer international cooperation required, it proposed to actively adopt the ICH Q-trio, such as Q8, Q9, and Q10 for the supply of safer pharmaceutical products rather than focusing on the international harmonization itself.
In addition, based on the result of the survey on the QbD and QRM, it proposed the strategies to adopt these as follows;
First, government-driven program is needed for the dissemination of QbD and QRM and the establishment of infrastructure. As QbD and QRM system can assure the supply of high quality pharmaceutical products, the infrastructure is required as soon as possible. For this, multi-dimensional strategies are necessary, especially in the areas of research and development improvement, new system adoption(revision of regulations) and fostering experts. For that, simultaneous programs focusing on these three axes should be performed, while the government invest its budget to the industry for at least 5 years for the establishment of infrastructure of product development. A few successful examples will be disseminated and encourage the whole industry.
Second, government needs to adopt risk-based approach in the quality control and management such as routine GMP inspections as well as the adoption of QbD and QRM concept in product approval and management so that limited resources can be effectively used for the best risk management.
Finally, domestic pharmaceutical industry should be equipped with the abilities and capabilities to supply safer and better quality of products from the initial phase of development.