Inspection, Sampling, and Storage of Packing material
Receipt and Inspection of Packing material Containers
- Upon receipt of packing material, the same shall be placed in the quarantine store attached to the Packing Material Store.
- In-charge of the Packing Material Store shall inform the QC Department for the inspection of containers and taking of samples for testing and scrutiny on the format, “Packing Material Receipt Intimation”.
- The QC Personnel, on the receipt of intimation, shall visit the Packing Material Quarantine Store.
- The QC Personnel, along with the In-charge of the Packing Material Store, shall visually Inspect all the containers of the packing material as per the checklist titled “Check List for Incoming Packing Materials”.
- First of all the QC Personnel shall note the number of containers of material. He shall serialize all the containers as X of Y e.g. if there are 5 containers of the same lot then each container shall be denoted By its individual serial numbers such as 1/5, 2/5, 3/5, 4/5, and 5/5.
Sampling for Test and Scrutiny of Packing material
- After visually inspecting all the Packing material containers, the QC Personnel shall decide the number of samples to be taken depending upon the number of containers of each lot of the Packing Material.
- Each lot of Packing Material shall be sampled.
- In case of damage to the consignment, ascertain the extent of damage and the extent to which the consignment can be used. Enter the above details in the checklist.
- The QC Personnel shall assign a QC reference number to the Packing material sampled.
- Different lots of the different materials shall have different QC reference numbers.
- The containers shall be opened, sampled, and closed in such a manner as to prevent Mix-up of Their contents with other packing materials.
- Containers in which Packing materialsamples are taken shall be labeled properly with required particulars such as:-
- Name of the product for which the Packing Material is to be used.
- Batch Number of the product, if applicable.
- Container No.
- Total No. of containers
- QA Reference Number
- Date of Sampling
- Sampled by
The containers from which the samples are drawn shall be identified by affixing labels bearing the below-noted particulars:-
- “Quarantined- Sampled” label of yellow colour.
- Name of the product for which the Packing Material is to be used.
- Batch Number, if applicable
- Container No.
- Total No. of Containers
- QC Reference Number
- Date of Sampling
- Sampled by
The number of “Quarantined-Sampled” labels affixed shall be at least equal to the number of containers Opened. The labels shall be affixed to the front side of the containers so that they are easily visible.
Samples of packing materials shall be taken in polythene bags.
The quantity of sample drawn must be sufficient for control test purposes and also for reference purposes. In general quantity of each sample should be twice the quantity required for all tests to be carried out.
Samples that are drawn for testing and scrutiny purposes must not be returned to the containers from which those were taken.
Containers from which samples are to be drawn should be chosen at random. In addition, the containers which show damage or any other sign different from the original should be chosen for sampling.
For sampling, only one container shall be taken at one time for drawing samples.
The consignment shall remain in the quarantine store till the testing is completed and the sample is approved or Rejected by the QC Department.
The sample drawn by the QC shall be taken to the QC Department for testing and scrutiny and he shall test/scrutinize the PM Store as per the specifications given in STP regarding the Testing of that Packing Material.
QC Personnel shall prepare his test report in the format given in Annexure- III which shall be retained by him as a record.
Each consignment meeting the appropriate specifications and any related tests shall be approved and released for use.
Labeling of Approved / Rejected Packing Materials
Approved materials shall be identified by affixing “Approved” or “Released” labels of green colour on each container at an easily visible position. Simultaneously the ‘Quarantined-Sampled” labels shall be removed and accounted. The label shall bear the following particulars :
QC Release Slip For Packing Material
Name of the product for which the Packing Material is to be used, its Batch no., and Code No.
QC Reference No. and Date
Lot Qty.
Accepted Qnty.____________ Rejected Qnty._____________
Name and Sign of the chemist.
Affix an adequate number of “Approved” labels on the containers at different levels.
If the consignment is rejected, affix the “Rejected” label in red colour on each container. The label shall bear the following particulars :
QA Rejection Slip For Packing Material
Name of the product for which the Raw Material is to be used, it’s Batch No. and Code
QA Reference No. and Date
Lot Qty.
Accepted Qnty.____________ Rejected Qnty.____________
Name and Sign of chemist.
Any label affixed to the original container of the material shall not cover the important particulars given on the label of the manufacturer / Supplier.
Storage of Approved Packing Materials
Move the “Approved” material from the quarantine area to the “Approved Packing Material Store”, separately provided for Labels and other packing materials.
The approved Packing Materials shall be stored at the temperature as per storage conditions applicable to the material.
All the containers of the approved Packing Materials shall be properly stored on racks or pallets and spaced so as to allow proper cleaning and inspection. No material shall be stored directly on the floor.
The containers from which the sample has been taken shall be properly closed after sampling to avoid mix–up and exposure to dust.
All the approved Packing Materials shall be re-examined (re-tested) after the period of one year and the material shall be re-labeled accordingly.
The printed labels shall be stored separately in pigeon holes or drawers, product wise in a separate room having a double lock and Key, the one key of which shall be with the store Incharge and the other with the QA Department.
Storage of Rejected Packing Materials
Move the rejected Packing material to the “Rejected Material Area” with the approval of the Quality Assurance Department.
Necessary steps shall be taken by the In-charge of the Packing Material Store for the return of Rejected Packing Material to the supplier, for destruction as per SOP titled “Destruction of Materials and Documents,” as the case may be, with the approval of QA.