With regard to excipients and pharmaceutical packaging materials, the "Technical Requirements for Pharmaceutical Research of Chemical Inhalation Liquid Preparations" requires that...

On November 26, the Center for Drug Evaluation of the National Food and Drug Administration issued the "Technical Requirements for Pharmaceutical Research on Inhaled Liquid Preparations of Chemical Drugs", including technical requirements for prescription technology, technical requirements for quality control of original and auxiliary packages, technical requirements for quality research and control, and stability studies And other parts put forward specific requirements for excipients and pharmaceutical packaging materials

1.

For excipients that are not used in domestic and foreign marketed inhalation products, used in changes of the route of administration, or used in excess of the conventional dosage, the safety support basis for the inhalation route should be provided, and the safety data of other routes of administration cannot be simply substituted

For generic drugs, the type and amount of excipients in the prescription should usually be the same as that of the reference preparation.

Production Process

1.

For generic drugs, the quality and performance of the packaging materials shall not be lower than the reference preparation in principle to ensure that the quality of the drug is consistent with the reference preparation
.

2.
Packaging materials and containers in direct contact with drugs should comply with the packaging material standards issued by the State Food and Drug Administration, or the requirements of USP, EP, and JP
.
 

3.
Refer to "Technical Guidelines for the Compatibility of Chemical Injections and Plastic Packaging Materials (Trial)", "Technical Guidelines for the Compatibility of Chemical Injections and Pharmaceutical Glass Packaging Containers (Trial)", "Chemicals and Elastomers" "Technical Guiding Principles for Research on the Compatibility of Seals (Trial)" and other relevant technical guiding principles to carry out studies on the compatibility of packaging materials and containers
.

 For semi-permeable plastic ampoule packaging, the safety risk of the drug from the adhesive/ink extract in the label should be evaluated and researched
.
 

Quality research

Inhalation preparations are high-risk preparations.
According to ICH Q3D, scientific and risk-based assessments are used to determine the control strategy of elemental impurities in the preparations, including the elemental impurities that may be introduced in the original and auxiliary packages and production equipment
.

1, semi-permeable formulation of the plastic packaging system should be based on the guidelines stability requirements, low humidity conditions Stability
.
 

2.
Sterility inspection shall be carried out at the initial and final stages of the stability inspection.
Other time points can be replaced by the sealing inspection of the packaging system
.
 

3.
Carry out stability studies in use, such as the stability of the plastic ampoules after removing the outer packaging (including storage conditions and time), and reasonably formulate the storage conditions and service life after opening based on the research results
.
 

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