Handling of Raw and Packaging material due for Retesting and Expiry 1
This Document describes (Standard Operating procedure) SOP for Handling of Raw and packaging material due for Retesting and Expiry
SOP for Handling of Raw and packaging material due for Retesting and Expiry
I. Purpose & Scope:
- The purpose of this SOP for Handling of Raw and packaging material due for Retesting and Expiry
- This Standard operating procedure shall be applicable for Handling of Raw and packaging material due for Retesting and Expiry.
II. Responsibilities:
• All warehouse personnel shall be responsible to follow and implement this SOP.
III : Introduction and Procedural Part:
Procedure for Handling of Raw and packaging material due for Retesting and Expiry :
- Every month check the re-testing due date of raw and packing material and generate the list through software or manually prepared of re-test schedule for Raw Material & Packing Material due for next month and same shall be forward to quality control department in the last week of every month. Based on the re-test schedule warehouse person generate the re-test intimation form.
- Based on re-test schedule warehouse person generate the re-test intimation form for retest as per re-test requisition slip to QC as per Annexure-I.
- If the manufacturer has assigned an expiry date, then the same shall be recorded as expiry date. The material shall not be retested and on expiry material shall be quarantine and suitably disposed.
- In case of material like flavours, where “Best before date” is assigned by manufacturer, same shall be regarded as “Expiry date” & material shall not be re-tested.
- If no manufacturing / expiry date is assigned by the manufacturer then the date of receipt of material at stores shall be recorded as manufacturing date. The material shall be assigned an expiry of 5 years and retested as per table mention below.
- The reanalysis date shall never exceed the original expiry date or retest date of material / product.
- Following guidelines are to be followed for retesting of various Items.
| Sr. No. | Name of the Material | Retest period |
| 1 | Active Material | Once in a year |
| 2 | Excipients (Non-Micro) | Once in two years |
| 3 | Excipients (Micro) | Once in a year |
| 4 | Hard Gelatin Capsule shell | Once in a year |
| 5 | Color | Once in a year |
| 6 | Flavors | Once in a year |
| 7 | Solvent | Once in two years |
| 8 | Primary Packing Material | Once in two years |
| 9 | Secondary & Tertiary Packing Material | Once in a five years |
- After receipt of re-test intimation slip, QC personnel shall resample the materials as per the sampling procedure.
- Before re-sampling, QC personnel shall ensure that the material is kept in ‘UNDER TEST’ area. Earlier ‘APPROVED’ label is defaced by QC personnel at the time of sampling.
- Raw Materials and Primary packaging materials shall be reanalyzed from the date of release.
- Additional / specific tests as applicable may be done during re-analysis.
- If the vendor ‘Retest’ dates of API’s received are less than one year from the date of analysis (In-house QC), same vendor retest date shall be mentioned on the label and analysis report.
- After testing as per QC specification for retest Parameters & release, if material is approved, transfer to “Approved” area ensuring “Approved” Label on each pack.
- For all the Re-analysis samples, new A.R. Number shall be allotted as per respective SOP.
- If the material / product pass, “APPROVED” label shall be affixed on each container as per respective SOP.
- If material is Rejected transfer to segregated “Rejected” area ensuring “Rejected” label on each container.
- If material is Rejected transfer to segregated “Rejected” area ensuring “Rejected” label on each container.
- The raw materials which are to be retested shall be labelled as “UNDER TEST’ must not be issued to the production department for use till it is Retested & approved by QC Department.
- In case any raw material is rejected, Head Stores must immediately report to Purchase /PPIC and QA for removal/ destruction / disposal of stocks from the Stores after completing all the formalities and the statutory compliances.
- All rejected/ obsolete material must be destroyed in presence of QA.
- If the extended retest COA of vendor is available, analysis report shall be re-written by transcribing the previous results with new retest date and label shall be pasted with new retest date proposed by vendor.
- Extend the retest date based on original communication received from the manufacturer.
ANNEXURE:
Annexure-I : Re-test intimation slip for Raw and Packaging materials
Annexure-II : Re-Test Schedule for Raw and Packaging materials
ANNEXURE-I
RE-TEST INTIMATION SLIP FOR RAW AND PACKAGING MATERIALS
Name of Materials with grade: _________________________________________________________
| Sr. No. | Materials details | |
| 1 | Item Code | |
| 2 | Batch No. | |
| 3 | Mfg. Date | |
| 4 | Exp. Date | |
| 5 | Current AR. No. | |
| New AR. No. | ||
| 6 | Manufacturer Name | |
| 7 | Supplier Name | |
| 8 | Due Retest Date | |
| 9 | No. of container | |
| 10 | Available Quantity | |
| 11 | Remarks (if any) | |
| Prepared by (Store ) | Received by (QC) | |
| Sign and date |
|
ANNEXURE-II
Re-Test Schedule for Raw and Packaging Material
Period From ——— To ———-
| Material Code | Material Name | AR.No. | Exp. Date | Balance Qty | Unit | Date of Approval | Retest due on |
Prepared By Received By
(Store Dept.) (QC Dept.)
