SOP on Testing of Primary Packaging Materials
Objective : To lay down a procedure for Testing of Primary Packaging Materials.
Scope : This Standard Operating Procedure is applicable at formulation plants.
Responsibility
QC- officer / Executive : Shall be responsible for carrying out sampling and testing of Packaging Material.
Head QC : Shall be responsible for compilation, review of results and Release of Products.
Head QA : Shall be responsible for compliance of this SOP
Abbreviations and Definitions
Primary Packaging Material : Packaging Material which is directly in contact with product e.g. laminate peel able Blister lidding, cold form Laminate, HDPE Bottle, cotton plugs, etc.
Procedure :
All Primary Packaging material shall be tested as per approved specification and test methods.
The primary packaging materials shall be tested for microbiological limit testing as per GTP, in case of only first three consecutive consignments from the Vendor.
After every one year, the approved primary packaging material shall be retested against test parameters mentioned on the respective specification, along with microbiological testing.
Sampling of the material to be retested shall be done as per SOP titled “Sampling Procedure for Packaging Materials”.
Stores shall be responsible to intimate QC about retesting date.
Once the Material has been identified to be retested, material shall be shifted from approved Quarantine area to under test area and “UNDER TEST” label shall be affixed.
After sampling of the material, “SAMPLED” label shall be affixed below the “UNDER TEST” label.
QC shall perform the analysis and as per results of analysis, QC officer shall affix “APPROVE LABEL” or “REJECTED LABEL” over the “UNDER TEST” label of each unit pack of primary packaging material container as per relevant SOP.