These aspects include development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances, drug （medicinal） products, biological and biotechnological products （including the use of raw materials, solvents, excipients, packaging and labeling materials in drug （medicinal） products, biological and biotechnological products）.〔【出典】ICHガイドライン 〕
For Weeks, the most striking discovery is the vast number of RNA structures that influence that virus's lifecycle, controlling how HIV infects humans and how rapidly it reproduces itself."VOA-T096", "2297881"
It is important to understand that product quality should be maintained throughout the product lifecycle such that the attributes that are important to the quality of the drug （medicinal） product remain consistent with those used in the clinical studies.〔【出典】ICHガイドライン 〕
Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of the drug （medicinal） product across the product lifecycle.〔【出典】ICHガイドライン 〕
The report states that due to the life-cycle of the mosquito and its role as host of the malaria parasite, "at low temperatures, a small increase in temperature can greatly increase the risk of malaria transmission" and "future climate change may increase transmission in some highland regions, such as in East Africa".〔【出典】Global Voices Online◆【英文】Juliana Rotich ◆【和訳】Hanako Tokita ◆【License】CC BY 3.0 〕
In addition to what is submitted in the application, certain aspects （e.g., product lifecycle management, continual improvement） of this guideline are handled under the applicant's pharmaceutical quality system （see ICH Q10）.〔【出典】ICHガイドライン 〕
It specifically provides guidance on the principles and some of the tools of quality risk management that can enable more effective and consistent risk based decisions, both by regulators and industry, regarding the quality of drug substances and drug （medicinal） products across the product lifecycle.〔【出典】ICHガイドライン 〕