SOP on Labeling & storage of Raw and Packaging materials

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1.0 Objective:

To lay down a procedure for labeling and storage of raw and packaging materials.

2.0 Scope:

This SOP is applicable for raw and packaging material warehouse in pharmaceutical formulation plant.

3.0 Responsibility:

Supervisory staff or above Warehouse is responsible for implementation of this SOP.

4.0 Accountability:

HOD – Warehouse shall be accountable for compliance of this SOP.

5.0 Abbreviations:

PVC                  :    Polyvinyl Chloride

PVDC                :    Polyvinyl Di Chloride

QA                     :    Quality Assurance

QC                    :    Quality Control

RH                     :    Relative Humidity

SOP                  :    Standard Operating Procedure

HDPE                :    High Density Poly Ethylene

PM                    :    Packaging Material

RM                    :    Raw Material

6.0 Procedure:

6.1 The received Raw materials after verification shall be transferred to the dedicated Quarantine areas. Duly filled ‘QUARANTINE’ label & signed by warehouse personnel shall be affixed on each Container / Bag / Drum or Box.

6.2 The received Packaging materials after verification shall be transferred to the dedicated Quarantine areas. Duly filled ‘QUARANTINE’ label & signed by warehouse personnel shall be affixed on each Box / Bundle or Bag.

6.3 Four ‘QUARANTINE’ labels duly filled & signed by warehouse personnel shall be affixed on each pallet of consignments on each side for Glass Vial, Glass Bottles, Shipper, Honey comb or Partition only.

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6.3.1 PM Storage in Oral warehouse:

6.3.1.1 All the packaging material (except Foils) shall be stored under lock & key in the cage available in the “Quarantine” marked with yellow color line on the floor.

6.3.1.2 All the Foils shall be transferred to the Quarantine & Approved Primary Packaging store & kept in the “Quarantine” marked with yellow color line on the floor.

6.3.1.3 The packaging materials in “Quarantine” shall be subjected for sampling by QC.

6.3.1.4 After sampling of packaging material by QC personnel, the “SAMPLED” label shall be affixed.

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6.3.1.5 The “SAMPLED” label shall be affixed on the top of right corner of Quarantine label affixed on pack(s) or roll(s) which has been sampled refer respective SOP.

6.3.1.6 After approval of packaging material by QC department, label shall be affixed by QC personnel with “APPROVED’ label in the space available on Quarantine Label (Orange portion below on the Quarantine Label)

6.3.1.7 Then material shall be transferred from “Quarantine” to Approved material storage area.

6.3.2 PM Storage in Injectable warehouse

6.3.2.1 All the packaging materials of Injectable products shall be transferred to “Quarantine” marked with yellow color line on the floor.

6.3.2.2 The packaging material in “Quarantine” shall be subjected for sampling by QC.

6.3.2.3 After sampling of packaging material by QC personnel, the “SAMPLED” label as per Format No. – QCSG001/F08 shall be affixed.

6.3.2.4 The “SAMPLED” label shall be affixed on the top of right corner of Quarantine label affixed on pack(s) or roll(s) which has been sampled refer respective SOP No.

6.3.2.5 After approval of packaging material by QC department, label shall be affixed by QC personnel with “APPROVED’ label in the space available on Quarantine Label (Orange portion below on the Quarantine Label).

6.3.2.6 Then material shall be transferred from “Quarantine” to Approved material storage area.

6.4 RM Storage in Oral warehouse:

6.4.1.1 All the Raw Material of oral products shall be transferred to the dedicated “Quarantine”.

6.4.1.2 The Raw material in “Quarantine” shall be subjected for sampling by QC.

6.4.1.3 After sampling of Raw material by QC personnel, the “SAMPLED” label shall be affixed.

6.4.1.4 The “SAMPLED” label shall be affixed on the top of right corner of Quarantine label affixed on pack(s) or roll(s) which has been sampled refer respective SOP.

6.4.1.5 After approval of Raw material by QC department, label shall be affixed by QC personnel with “APPROVED’ label in the space available on Quarantine Label (Orange portion below on the Quarantine Label).

6.4.1.6 Then material shall be transferred from “Quarantine” to Approved material storage area.

6.4.2 RM Storage in Injectable warehouse

6.4.2.1 All the Sterile Raw Material of Injectable products shall be transferred to the dedicated “Quarantine” along with representative samples.

6.4.2.2 The Sterile Raw material in “Quarantine” shall be subjected for withdrawn of representative sample by QC personnel.

6.4.2.3 After withdrawal of representative sample of sterile raw material, “SAMPLED” label shall be affixed on each canister by QC personnel.

6.4.2.4 The “SAMPLED” label shall be affixed on the top of right corner of Quarantine label affixed on pack(s) or roll(s) which has been sampled refer respective SOP.

6.4.2.5 After approval of Sterile Raw material by QC department, label shall be affixed by QC personnel with “APPROVED’ label in the space available on Quarantine Label (Orange portion below on the Quarantine Label).

6.4.2.6 Then material shall be transferred from “Quarantine” to Approved material storage area.

6.5 Precautions during storage of raw materials :

6.6.1 Loose (non-intact) materials shall be kept separately and has to be labeled properly.

6.6.2 The storage conditions for the Raw materials shall be maintained.

6.6.3 Drums, Canister, Boxes & Bags shall be kept on pallets.

6.6.4 Liquid Raw materials shall be stored in separate storage area under lock & key protected from direct sun light.

6.6.5 Precautions during storage of packaging materials:

6.6 Entire label rolls of Oral / Injectable warehouse shall be kept under lock & key in almirah.

Note:-

A – Rejected raw materials & packaging materials consignment shall be stored in “REJECTED MATERIAL ROOM” under lock & key. Affixed ‘REJECTED’ label in the space available on Quarantine Label (Orange portion below on the Quarantine Label).

B – In case of “On line rejection “affixed “INPROCESS REJECTED” label.

C- The warehouse personnel shall monitor & maintain record of temperature and relative humidity as per respective SOP.

7.0 List of annexure / Formats

Not Applicable

8.0 References :

  • SOP on in-process labeling system & its format numbering.
  • Sampling procedure of Packaging Material
  • SOP on testing & approval / rejection of packaging materials
  • Sampling of raw material
  • SOP on analysis, approval and rejection of raw material
  • Receipt of Raw Material & Packaging Material
  • Monitoring of temperature, Relative Humidity and pressure differential
  •  Issuance of Raw Material and Cleaning of dispensing booth, dispensing tools and dispensing areas.

9.0 Distribution

9.1   Master Copy                                     : Documentation Cell (Quality Assurance)

9.2   Controlled Copies                            : Quality Assurance, Warehouse, Quality Assurance, Production (Oral & Inj.) and Quality Control.

10.0 History

     Date    Revision Number                       Reason for Revision
                       New SOP

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