1. Purpose
Ensure timely management and supply of reagents for testing.
2. Scope of application
Management of laboratory chemical reagents
3. Responsibility
Laboratory technicians and chemical reagent custodians should strictly abide by this operating procedure, and the QC supervisor is responsible for supervising this procedure.
Implementation of the regulations.
4. Definition
none
5. Safety Precautions
none
6. Procedures
6.1. Reagents should be classified and stored in specified medicine cabinets. The storage of reagents should be neatly arranged. Reagents with similar product names should be placed separately to avoid confusion. Organic solvents should be stored in the organic solvent room. Use of highly toxic drugs should comply with SOPSAF059 "Measures for the Administration of Violent Drugs". Flammable and volatile reagents should be stored in explosion-proof refrigerators, and the storage of reagents should pay attention to the chemical properties of the drugs.
6.2. When opening a new bottle of reagent, the operator should promptly fill in the "Reagent Unpacking Registration Form" (see Appendix 1) and "Reagent Unpacking Label" (see Appendix 2), and stick the label on the reagent bottle. For the liquid reagents used in the preparation of mobile phases or diluting the test products in large quantities, such as methanol, ethanol, toluene, acetonitrile and other reagents, since the reagents will not be kept for one year after unsealing, it is not necessary to affix an unsealing label on such reagents And fill in the unsealing record for management.
6.3. When taking the test drug, you should recognize the name of the product to avoid mistaking it. After use, you should tidy up the original packaging and put it back in time to avoid confusion or affect other people's use.
6.4. Purchasing personnel should purchase reagents produced within the past two years.
6.5. Reagent expiration date regulations:
Regardless of the reagent, the expiry date provided by the supplier must not be exceeded. Reagent custodians should check once a month. All expired reagents should be inspected for physical appearance. If they are qualified, they can be extended appropriately with the approval of the QC supervisor. The extension period is the time interval between the receiving date and the opening date of the reagent; If it is qualified, it will be discarded.
6.6. In case of any of the following situations, the test drug custodian should be reported.
6.6.1 It is found that there are not many test drugs left.
6.6.2 When the quantity of highly toxic drugs is incorrect.
6.6.3 Need to use new reagents.
6.4. The test drug custodian shall conduct an inventory of the test drug inventory in the laboratory every quarter, fill in the purchase application form as needed, and submit it to the material department for timely supply.
7. Reference
SOPSAF059
GMPcs-021
8. Distribution department
Quality Assurance Department
9. Revision history
Separate regulations are made for those prescribed by the Pharmacopoeia or whose validity period is found to be less than 6 months during the experiment.
