Sampling and Release of Semi finished Product


  • SAMPLING OF SEMIFINISHED PRODUCT
  • Samples collected during granulation or blending stage for solid oral dosage forms shall be considered as semi finished product samples.
  • As per BPRR at the end of the each activity, production executive shall issue “SAMPLE TEST REQUEST FORM” to IPQA personnel.
  • IPQA personnel shall sample and submit all samples to the QC department after completion of process as per  

the Batch Manufacturing record through sample test request form. Incase of  validation samples, submit the

          samples as per the validation Protocol through   “VALIDATION SAMPLE TEST REQUEST FORM’

  • During dry mixing, samples shall be collected as per the validation protocol for the respective products.
  • After completion of drying process, IPQA executive shall collect the sample for LOD / Water by KF / water activity tests from different locations by using cleaned sampling thief and transfer to double polyethene bag  after mixing.         

       Approximately 5 grams of pooled sample shall be taken for the test.

  • After lubrication wherever applicable, IPQA person shall collect approximately 35 grams of composite blend from different locations of the IPC container / laminated bag after unloading from octagonal blender in the LDPE bag.
  • Samples of blend uniformity (Wherever applicable) are sampled as per validation protocol / Batch Manufacturing record are sampled in vials with rubber stoppers.
  • Blend uniformity samples shall be drawn with the unit dose sampler as per SOP
  • All samples collected by IPQA executive shall be affixed with duly completed and Signed SAMPLE FOR TESTING  

         label before sending to QC for  testing. 

   REALESE OF SEMIFINISHED PRODUCT:

  • After testing of the semi finished samples, QC shall issue in process Certificate of analysis along with Approved   

         Label and raw data to Section in charge QC/Analytical Assurance.   

  • Section In charge QC / Analytical assurance personnel shall review the COA and the raw data. If found satisfactory, Approved Label along with the In-process COA shall be forwarded to IPQA
  • Raw data shall be submitted to the documentation cell for archiving.
  • IPQA personnel shall complete the review of the and In process COA and the BPRR shall be signed off to release the batch for further processing.

      Note: If semi finished product is not meeting as per the specification, the same shall be investigated as per SOP      

       [Investigation of Out of Specification Results (OOS)] and SOP (SOP for Failure Investigation)

       

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