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Compatibility test drug packaging and drug Principles

發布日期:2015-4-3    閱讀數:1555

make drug packaging and drug compatibility test should primarily consider the following aspects:

1. When forming a packaging unit, each packaging should have good sex with as glass infusion packaging aluminum cap, stopper, bottle with three

2. When the packaging unit is formed to fit specific packaging equipment;

3. Drug packaging, all items pass drug stability test (see "Chinese Pharmacopoeia" 2000 edition of Appendix emphasis on the project in various formulations);

4. Medical Packaging tolerance special treatment according to the production process requirements;

5. The same packaging unit for the first time to the end of secondary guarantee consistent (The project investigated the impact of packaging forms) drugs;

6. To bad transport, resistance to different storage environments;

All tests should be based on the specific form of packaging design and drug testing program, press the "non-clinical drug research quality management practices" (GLP) performed for all samples should be listed on the packaging.

Expert appeal: the introduction of tests and assessment as soon as possible.

drug packaging and drug compatibility test is in a controlled environment, select an experimental model to study medicinal packaging materials and drugs with each other or whether unilateral migration occurs, deterioration , thus confirming the entire drug use within the validity period of the drug containers to maintain the safety, effectiveness, uniformity, purity can be controlled.

Accordingly, the pharmaceutical packaging materials production enterprises must fully guarantee the safety of products provided, effectiveness; drug manufacturers to select drug packaging is necessary to take into account the protection of drug packaging, but also take into account drug packaging and drug compatibility. When the following conditions occur, the drug should be drug packaging and compatibility testing.

1. Drug packaging, drug when the source changes or changes;

2. Drug packaging, drug production technology, production process changes;

3. Medical Packaging formula, process, change the primary raw materials are likely to affect the function when the drug;

4. Within the validity period of drug, it is shown that the performance of the drug when changes;

5. When adding or changing the use of drugs;

6. When Medical Packaging should be the approval of new drugs;

7. After long-term use, drug packaging found adverse consequences for particular drugs.

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