Batch Release At Various Manufacturing Product

Batch Release At Various Manufacturing Product

OBJECTIVE:

To lay down procedure for stage wise release of the batch.

PROCEDURE:

In Process Tablets

Release for Compression

  • Receive QC release for Blend in writing.
  • Check that the line clearance has been carried out by Production & verified by QA.
  • Check that the BMR is duly filled & signed by the concerned persons up to the Blending stage & all the parameters are within limits.
  • When all these are complete, put the stamp of “RELEASED BY QA” in Green on the stamp of each container containing the Blend of the concerned batch.

Release for Coating

  • Receive QC release for Compressed Tablets in writing.
  • Check that the Line Clearance has been carried out by Production & verified by QA.
  • Check that the BMR is duly filled & signed by the concerned person up to the Compression stage & all the parameters are within limits.
  • When all these are complete, put the stamp of “RELEASED BY QA” in Green on stamp of each container containing compressed tablets of the concerned batch.

Release for Packing (for uncoated and coated tablets)

Receive QC release for tablets in writing.

Check that the line clearance has been carried out by Production & verified by QA.

Check that the BMR is duly filled & signed by the concerned persons up to the inspection stage of tablets – all the parameters are within limits.

When all these are complete, put the stamp of “RELEASED BY QA” in Green on the stamp of each container containing tablets of the concerned batch.

In process capsules

Release for Capsule Filling.

  • Receive QC release for blend in writing.
  • Check that the line clearance has been carried out by Production & verified by QA.
  • Check that the BMR is duly filled & signed by the concerned persons up to the blending stage & all the parameters are within limits.
  • When all these are complete, put the stamp of “RELEASED BY QA” in Green on the stamp of each container containing the blend of the concerned batch.

Release for Packing

  • Receive QC release for filled capsules in writing.
  • Check that the line clearance has been carried out by Production & verified by QA.
  • Check that the BMR is duly filled & signed by the concerned persons up to the capsule filling & Inspection of capsules – all the parameters are within limits.
  • When all these are complete, put the stamp of “RELEASED BY QA” in Green on the stamp of each container containing filled capsules of the concerned batch.

In process liquid orals

Release for Filling

  • Receive QC release for Bulk Syrup / Suspension in writing
  • Check that the line clearance has been carried out by Production & verified by QA.
  • Check that the BMR is duly filled & signed by the concerned persons up to the Bulk Manufacturing stage & all the parameters are within limits.
  • When all these are complete, put the stamp of “RELEASED BY QA” in Green on the stamp of the storage tank container containing Bulk Syrup / Suspension of the concerned batch
  • In case of any Deviations, fill out the deviation forms duly authorized by QA & then proceed further

In-process granules

Release for Granules filling & packing

Receive QC release for blend in writing.

Check that the line clearance has been carried out by Production & verified by QA.

Check that the BMR is duly filled & signed by the concerned persons up to the blending stage & all parameters are within limits.

When all these are complete, put the stamp of “RELEASED BY QA” in Green on the stamp of each container containing a blend of the concerned batch.

Final batch release

See that the BMR & BPR are duly filled.

See that all the items mentioned on the BMR Checklist are available.

Review the BMR & BPR. If anything is missing, give the list of discrepancies to production & comply with it.

Receive Certificate of Quality for finished pack sample.

After the correction of discrepancies, check the BMR/BPR once again for the correctness of the data. Finally QA Head or designee shall check the BMR.

An authorized person should check the BMR and BPR thoroughly. Should also ensure the closure of deviations, if any.

The authorized person should then put the GREEN stamp of “RELEASE BY” on the last page of BMR and should sign on it to show that the batch has been released for sale.

The Xerox copy of the “Certificate of Quality” should be given to the warehouse, to transfer material from the “Quarantine area” to the “Released area”.

For the tests, which take a longer time for completion, e.g. microbial purity, to save time for transportation, a “Provisional release” shall be given for dispatch of the products up to the distributor.

Dispatch of products through provisional release

Review and verified that the BMR & BPR are duly filled.

Review and verified that all the items mentioned on the BMR Checklist are available.

Review the BMR & BPR. If anything is missing, give the list of discrepancies to production & comply with it.

Review and verify the Certificate of Analysis for chemical tests only for the finished product.

After the correction of discrepancies, check the BMR/BPR once again for the correctness of the data. Finally QA Head or designee shall check the BMR.

An authorized person should check the BMR and BPR thoroughly. Should also ensure the closure of deviations, if any.

An authorized person should prepare the Provisional release and should approve it and send it to the Warehouse for batch dispatch to the Sano Cito Unit-II warehouse.

The Xerox copy of “Provisional Release” should be kept in QA with COA.

When the analysis for Microbial Purity is completed and if it complies with the specification, QC prepares the final COQ and sends it to QA for final approval by QP. After final approval, the COQ is sent to the Warehouse for the final release of the batch for sale.

shall meet finished product specification except for mentioned tests in point 6.6 and further dispatch to the market of the product shall be upon confirmation of the product’s final release

The final release for further sale shall be given only after completion of the above-referred tests described by preparing a Release Order and written information to the Warehouse personnel for the final release.

The final release order shall be attached with BMRs/BPRs.