ICH Q3D recommends a science and risk-based approach to evaluate the potential for introduction of EIs into the drug product and to determine if additional controls need to be included in the overall control strategy to ensure product quality and safety. The overall process follows the sequence identify, evaluate and summarise.
To determine whether medicinal gases are likely to contain any EIs, specified in ICH Q3D, EIGA members performed a risk assessment (RA) which considered which EIs could theoretically be present in the licenced drug products. The maximum daily dosages (MDD) were also calculated for each medicinal gas to determine which medicinal gases were at the highest risk, see Section 4.
The scope of this publication covers all packaged medicinal gases as listed below produced by EIGA members and approved as designated medical gases by the U.S. Food and Drug Administration (FDA) or authorised as medicinal products in other jurisdictions. It covers both compressed and liquefied gases, supplied in high pressure cylinders as well as cryogenic liquids, supplied either by tankers into bulk storage tanks or in portable cryogenic containers. It considers all manufacturing processes, including the starting materials used, as well as the CCS used to supply these medicinal gases for patient use.
It covers the quality of the gas up to the point of delivery into the customer’s storage tank or at the outlet valve in either high pressure cylinders or portable cryogenic containers. It does not address the quality of the gas once it has been distributed to the usage point via the customer’s pipeline system.