Standard operating procedure for sampling of packing materials in pharmaceuticals.

1.0 Purpose:

To lay down a procedure for Packing material sampling.

2.0 Scope:

This SOP is applicable for Packing material sampling in Quality Control department.

Sop for sampling of packing materials in pharmaceutical

3.0 Responsibility:

QC Officer/Executive/Designee :
•To enter the details in the Packing material inward register.

•To sampling of packing material as per procedure.

•To ensure the material receive from the approved vendor.

•To follow status labeling procedure.

•In case of any discrepancy inform to QC Head/designee.

QC Head/Designee :
•To review and implement and ensure compliance of SOP.

• In case of any discrepancy inform QA & Warehouse Head / designee.

QA Head/Designee :
To approve, implement and ensure compliance of SOP.

4.0 Procedure:

4.1 After receipt of the Packing material GRN from warehouse, QC officer/designee shall enter the details in the packing material inward register and allocate the A.R. number.

4.2 Ensure that the material is received from the approved vendor by referring the approved vendor list.

4.3 QC Officer/designee criteria of sampling of packing material shall be as follow:

4.3.1 If total number of packs/containers shall receive five or less than five, sampling of each container/bag i.e. 100%.

4.3.2 If total number of packs/containers shall receive more than five, sampling shall be as per √n+1 Formula ( Where n is total number of containers/bags)

4.3.3 (Example: If a batch having 25 number of pack/containers, total 6 number of pack/container to be sample , √n+1 = √25+1 = 5 + 1=6 Nos.)

4.4 QC Officer/designee shall prepare require status labels (Under Test, Sampled, Sample for analysis)

4.5 QC Officer/designee shall go to Warehouse with sampling kit which contains GRN, sampling checklist, status labels, polythene bag, rubber bands, cutter, plain BOPP tape and scissor.

4.6 QC Officer/designee shall verify the consignment against GRN details and check the Packing material.

4.7 QC Officer/designee shall visually check the consignment. In case of any abnormality observed, inform to QA & Warehouse Head/designee.

4.8 QA Head/designee shall take decision based on condition of packs / containers and inform to QC for further sampling activities.

4.9 QC Officer/designee shall select packs/containers randomly, open one pack/container at a time and collect the quantity of sample.

4.10 Affix duly filled and signed Under test labels on all over Quarantine Labels near the quarantine label. Affix Sampled labels near right top corner of under test labels.

4.11 After sampling, QC Officer/designee shall close the open pack/containers properly and keep it at designated place in ware house.

4.12 After completion of whole activity of sampling, maintain the sampling log book.