Production

  • The production supervisor rechecks the weights of dispensed material in production department.
  • Manufacturing process is done strictly as per procedure given in MFR. GMP is strictly followed.
  • The BMR moves along with the product from section to section and all relevant entries are recorded as the process progresses.
  • The first three batches of any product are manufactured jointly by R&D and Production Department and are evaluated by the Quality Assurance Department.

IN-PROCESS QUALITY EVALUATION

  • Q.A. personnel will perform in-process checks to ensure that activities are carried out as per SOP and products are manufactured as per the prescribed standards.
  • Q.C. Department tests the composite samples of granules / tablets before they are taken for further processing.
  • The batches are analyzed as per the documented specifications.
  • The results of complete analysis are entered in the protocols and the Certificate of Analysis is prepared. One copy of COA is sent to production section for attachment in BMR.
  • RELEASED labels are affixed on the bulk containers and then the batch is sent to the next stage of processing along with BMR.

FILLING / COMPRESSION / PACKING

  • All materials of previous products are removed from the area before starting next product and line clearance is obtained from Q.A. Department.
  • Product changeover on the machine & its clearing is done as per SOP.
  • Q.A. Department gives line clearance report before starting of filling / compression and packing operation. For tablets to be coated, they are coated only after Q.C. release of core tablets.
  • The coated tablets are again analyzed by Q.C. Department. After release of coated tablets, they are transferred to blister / packing section.
  • I.P.Q.C. chemist carries out weight variation, leak test and all other in process checks required to be carried out during filling / packing operations.
  • Production chemist checks the process control parameters.
  • Q.C. personnel draw sample from finished packs for testing and to preserve the required no. of packs for Control Sample.
  • Q.A. ensures that BMRs are complete in all respects. The release for sale is given by the Q.A. Manager only after complete analyses of the product as per the Standard specifications and meeting of other parameters including the documentation.
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