SOLITAIRE PHARMACIA PVT. LTD.

1.Objective

To define the procedure for labeling and storage of under test, approved and rejected RM & PM.

2.Scope

This SOP is applicable to raw and packaging material stores atSolitaire Pharmacia Pvt. Ltd., Baddi.

3.Responsibility

Executive - Raw Material/Packing Material Stores

4.Accountability

Head Stores

5.Procedure

  1. Raw and packaging materials received from vendor shall be kept in respective under test area with duly filled and signed ‘UNDER TEST’ label (Yellow colored), affixed on each Container.
  2. After the approval of the raw and packaging material from QC, the approved material shall be labeled by Quality Control Personnel with “APPROVED” label affixed above “UNDER TEST” label so as not to cover yellow portion of the label.
  3. The Approved material shall be shifted from under test area to approved material storage area by the stores personnel as given below.

Active material into the active Material storage area.

Packing material into the Packing store.

Excipient into the Excipient storage area.

  1. Sampled containers to be kept in the front row and marked as “SAMPLED”.
  2. Stores personnel shall store all Material on pallets.
  3. Raw material, thermo-labile material, and liquid material which require storage in a cool place, shall be stored in controlled environment in specified storage locations.
  4. Proper relative humidity shall be maintained for moisture sensitive raw materials as per storage conditions and area monitoring shall be done as per specified frequency.
  5. All the rejected materials shall be affixed with duly filled and signed “REJECTED” label by QC Personnel & stored under lock and key in the “REJECTED AREA”.
  6. The stores officer (or above) shall ensure that proper conditions of temperatures are maintained and shall record the same in temperature record as per Format No. SPL/QA/024 of SOP on “monitoring of temperature and humidity” SOP No. SPL/SOP/QA/011.
  7. Precautions to be taken during storage of raw materials:
  8. Material shall be stored clear from the walls.
  9. The liquid Raw Material shall be stored in lower most racks.
  10. Loose (non-intact) materials shall be kept separate in a clean marked polybags in its original container till it is used completely and shall be labeled as “LOOSE”.
  11. Material shall be kept away from direct sunlight and localized source of heat.
  12. Containers shall be kept in vertical position.
  13. Polybag linings of containers shall be closed tightly for better safety of material.
  14. Bin Cards shall be updated immediately after material in or out.
  1. Records/Formats:

SPL/WH/004 to 007- Material Status Label

SPL/WH/008-Bin Card (Raw Material)

  1. Annexure

NA

  1. Reference:

Nil

  1. Abbreviations:

SOP-Standard Operating Procedure

Q.A-Quality Assurance

N.A-Not Applicable

RM-Raw Material

PM-Packing Material

  1. Revision History:

Revision No. / Effective Date / Reason for Revision
00 / New Document

Format No.SPL/QA/001

SOLITAIRE PHARMACIA PVT. LTD.

BIN CARD (Raw Material)

Format No. SPL/WH/008

Formate No : SPL/WH/008
Solitaire Pharmacia Pvt. Ltd., Baddi. (INDIA)
BIN CARD (Raw Material)
Date / Description / Batch
Lot / Qty / Balance / Sign
Exe. Store
Received / Issued

Format No.SPL/QA/001

SOLITAIRE PHARMACIA PVT. LTD.

Material Status Label

Format No. : SPL/WH/004 - 007

/ Solitaire Pharmacia Pvt. Ltd., Baddi.

Material Name /Item Code______
Mfgrs / Suppliers Name ______
GRN No./ ______Batch No. ______Batch / Lot Size ______
Mfg. Date______Exp. Date______
No. of Containers ______Container No. ______
For Qc Deaprtment
(Sign / Date)
UNDER TEST
/ Solitaire Pharmacia Pvt. Ltd., Baddi.

Material Name /Item Code______
Mfgrs / Suppliers Name ______
GRN No./ MRN No. ______Batch No. ______Batch / Lot Size ______
Mfg. Date______Exp. Date______
No. of Containers ______Container No. ______
Approved By ______A.R. No. ______
For Qc Deaprtment
(Sign / Date)
APPROVED

Format No.SPL/QA/001

SOLITAIRE PHARMACIA PVT. LTD.

/ Solitaire Pharmacia Pvt. Ltd., Baddi.

Material Name /Item Code______
Mfgrs / Suppliers Name ______
GRN No./ MRN No. ______Batch No. ______Batch / Lot Size ______
Mfg. Date______Exp. Date______
No. of Containers ______Container No. ______
rejected By ______A.R. No. ______
For Qc Deaprtment
(Sign / Date)
REJECTED
/ Solitaire Pharmacia Pvt. Ltd., Baddi.

Material Name /Item Code______
Mfgrs / Suppliers Name ______
GRN No./ MRN No. ______Batch No. ______Batch / Lot Size ______
Mfg. Date______Exp. Date______
No. of Containers ______Container No. ______
For Qc Deaprtment
(Sign / Date)
UNDER QUARANTINE

Format No.SPL/QA/001