Friday, November 26, 2010

Sampling, Testing and Release of Packing Materials

1.0  Purpose     :   To provide an instruction for sampling, testing and release of packing materials.

2.0      Objective :  To provide a documented procedure for sampling, testing and release of packing       materials.
3.0      Scope        :  This procedure is applicable for sampling, testing and release of packing materials in QC department of ----- Pharmaceutical Ltd, 

4.0   Responsibility  :
·        Primary   :  QC Chemist / QC Officer
·        Secondary  : Overall: QC – Incharge

5.0  Procedure  :
·        After receipt of intimation / goods received note (GRN) from store department, enter the details of the GRN in the inward register and give AR No.
·        Prepare the required number of sample labels as per the quantity of packs mentioned in the GRN and as per the sampling plan.
·        Take the respective specifications and GRN while going to sample the packing material samples in stores.
·        Inspect the quarantine labels pasted on the packs as per the GRN.
·        Checks packs to be sampled with respect to
Ø      No. of Packs.
Ø      Condition of pack.
Ø      Details on the pack label as per GRN.
Ø      Quantity.
·        In case of any discrepancies inform to QC In-charge.
·        Bring the packs to be sampled in the specified sampling area.
·        Affix the sampled label duly signed and dated on pack from which sample is drawn.
·        Enter the sampled quantity and other details in the packing material log book.
·        Bring specified quantity of samples to QC for testing.
·         Perform the tests as per the specifications.
·        Packaging Material sampling plan
Ø      n = √N + 1,   n = number of plan.
Ø      Under this plan, samples shall be taken from each of √N + 1 sampling  units in the consignment,     
·        Testing procedure.
·        After the receipt of intimation / GRN in the Q.C. Lab, the Q.C. Chemist makes the entries in the Packing material register.
·        Based on the priority, Q.C. In-charge then allots the chemist to sample & test the packing material.
·        The QC chemist collects samples based on the sampling plan and makes necessary entries in packing material register.
·        QC chemist refers the Packing material specifications and examines the material.
·        He prepares the necessary worksheet & COA based on the observation.
·        The completed set of GRN along with COA is given to QC In-charge who checks it and states the material to be approved / Rejected. GRN are signed by QC In-charge and sent to stores.
·        Subsequently, the required entries are entered in the Packing Material register.
·        QC chemist prepares “Approved “ labels and affix them on all the containers / bags of the material tested.
·        The material is then released for use.
·        If material is rejected, QC Chemist must be put “Rejected” label on all the containers of the material received.

Log book for Packing Material


Sr. No.
Date
Name of Packing material
Item code No.











GRN No.

Manufacturer / Supplier
Qty. received/
No. of containers
Sampled by
Sampled qty.
A.R. No. / Date
Remarks







Format:-F/QC/005
            

log book for packing material work sheet issuance


Sr. No.
Name of
Packing material
A.R. No.
Date of issue
Work sheet no.
Given by
Sign
Remarks








Format:-F/QC/006
         

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