by 1.0 OBJECTIVE
To lay down the procedure for assigning expiry dates to laboratory chemicals and solutions.
2.0 SCOPE
This procedure is applicable for assigning expiry date of solvents, chemicals & reagents, test solutions, mobile phase, buffer/ diluents, standard solutions for limit test and volumetric solutions used in the QC laboratory .
3.0 RESPONSIBILITY
Executive – QC
4.0 DISTRIBUTION
Master copy : Quality Assurance Department
Controlled Copy – 1 : Quality Control Department
5.0 PROCEDURE
| Item Description | Validity |
| 5.1 Solvents | 1 year from the date of receiving unless otherwise mentioned on the labels |
| 5.2 Chemicals & Reagents (Solid Chemicals) | 5 years from the date of receiving unless otherwise mentioned on the labels. 1 year from the date of receiving unless otherwise mentioned on the labels. (For Hygroscopic material) |
| 5.3 Test / Reagent Solutions | 3 months from the date of preparation, unless otherwise mentioned in the Test Procedure |
| 5.4 Mobile Phase | 4 days from the date of preparation ( four days including the date of preparation), unless otherwise mentioned in the Test Procedure |
| 5.5 Standard Solutions | |
| 5.5.1 For Limit Test | 3 months from the date of preparation, unless otherwise mentioned in the Test Procedure. |
| 5.5.2 For Qualitative Analysis | 3 months from the date of preparation (provided that they meet all the requirement of test) unless otherwise mentioned in the Test Procedure. |
| 5.6 Volumetric Solutions | 15 days from the date of preparation with the consideration that the solutions do not differ from the prescribed strength by more than 10%. Note: If the manufacturer’s expiry date is available, it should be used as is without any change. |
5.7 For Solutions or reagents that are transferred from large volume containers to small ones to be used in the laboratory, following instructions apply:
5.7.1 The large volume pack size is to be labeled with date of opening on reagent label.
5.7.2 The container into which the sample is transferred will be labeled with general reagent.
5.7.3 The validity given will be that on the original pack from which the material is transferred or as applicable from point 5.1 to 5.6 above.
5.8 Water Reagent:
5.8.1 Water used in all tests, assays and any other analytical purposes is Purified water, unless otherwise specified in the Test Procedure.
5.8.2 Water containers or bottles must be used within one day from the filling date and labeled properly. Use the purified water for the preparation of mobile phase.
5.9 Affix label
5.9.1 Test / Reagent solution(Pink Colour)Volumetric Solution (Orange colour)General reagents (white colour)Mobile phase (Blue Colour)
5.9.2 Enter all details as required in the labels.
5.10 Check the physical appearance of the item properly before use. If there is any doubt as haziness, presence of external materials, microbial growths etc. discard the item and prepare new item.
5.11 In every 15± 2 days all the reagents shall checked to identify the presence of any expired or going to be expired reagents in next 15 days. If during the checking of reagent any expired reagent or going to be expired reagent is found it is captured as per annexure.
6.0 ANNEXURE
Annexure –1: Test / Reagent solution label.
Annexure –2: Volumetric Solution Label.
Annexure –3: General Label for opening a reagent container.
Annexure –4: Mobile Phase Label.
Annexure –5: General reagent Label.
Annexure -6: Label for purified water.
Annexure -7: Reagents Inventory (Expiration Date) Checklist.
7.0 ABBREVIATIONS
QC – Quality Control.
8.0 REFERENCES
None
9.0 REVISION / REVIEW CARD
| S. No. | Date | Details & Reason for Revision/Review | Revision No. |
| 01 | ……… | New | 00 |
