SOP on Retesting of Primary Packing material
Objective: To lay down the procedure for retesting of primary packing material for material lying in warehouse for longer period.
Scope: This SOP is applicable for retesting of primary packing material for material lying in warehouse for longer period.
Responsibility: Chemist or above of QC Department & Officer or above of Warehouse Department.
Accountability: Head – Quality Control.
Procedure: On receipt of material, warehouse shall send the GRN to QC as per SOP and QC shall perform sampling of packing material as per SOP and release the material as per SOP.
At the time of release of primary packaging material, QC person shall assign in-house retest date of material as per below mentioned table-1
Table-1.
| Sr. No. | Name of Primary Packing Material | Retest Period |
| 1 | All type of Foils | 2 years |
| 2 | Rubber Stopper | 6 Months |
| 3 | HDPE Containers (Bottle) | 2 years |
| 4 | White Closure with induction wad | 2 years |
| 5 | LDPE Bag | 2 years |
| 6 | Activated carbon 1 gram pouch | 6 months |
| 7 | 1 gram 2-in-1 desiccant pillow pouch | 6 Months |
| 8 | Triple Laminated bag | 2 years |
| 9 | Glass Vials | 2 years |
| 10 | 1 gram Silica Gel Pouch (Roll Form) | 6 Months |
Retesting can also be carried out as per any directive from Quality assurance department on need basis or risk analysis.
In case, if expiry date assigned by vendor is coming before the in-house retest date, then re-test date shall not be applicable and material shall be considered expired as per label from vendor.
If retest or re-evaluation date assigned by vendor is coming before the in-house retest date, then retest date shall be in line with that of vendor. Thereafter the material shall be reassessed immediate before use to establish its suitability. The validity of this reassessment shall be as per given tablet -1 from the date of release. This shall be followed till the material continues to meet with the specification.
After receiving re-test request from ware-house, QC personnel shall enter the material details in re-test packing material control register.
QC personnel shall allot the A. R. No. by adding suffix ‘/ Rn’ where ‘/’ is for separation, R is for retesting and n is the number of times of re-testing after the initial analysis for the release of the material. For example, if request for re-testing of packing material is received first time and the initial A. R. No. is PM/25/0001 then A. R. No. of re-test material shall be PM/25/0001/R1 and packing Material sampling shall be done as per SOP.
‘TEST FOR RETESTING’ mentioned in the respective packing material specification, shall be performed during retesting of packing material.
Analysis and approval of re-test packing material shall be done as per SOP.
During COA preparation for retested packing material, the analytical data for the test performed during retesting shall be included and other test shall be taken from initial analysis and COA shall be prepared as per SOP.
Expired or rejected packing material shall be destroyed by ware-house as per SOP.
List of Annexure
- Retest packing material Control Register
- Test to be performed During Re-testing of primary packaging material