SOP For batch release system of finished product is described in this post which you can follow in the section of the Quality Assurance Department.

OBECTIVE

To lay down the procedure for approval and release of the finished product batch.

SCOPE 

This Standard Operating Procedure is applicable for all batches of finished products manufactured at the pharmaceutical drug manufacturing plant.

RESPONSIBILITY

Q.A Officer

ACCOUNTABILITY

Manager Quality Assurance

PROCEDURE 

Production shall submit Batch Manufacturing Record and Batch Packaging Record after review from Production Pharmacist and final approval from production and QA Manager.

IPQA personnel shall ensure that the control samples and other samples like stability /microbiology/ validation samples in a product have been collected as applicable.

Batch Records Review:

On receipt of the batch records (both batch manufacturing and batch packing records), QAI shall review the documents for any discrepancy or deficiency, which impacts the product quality/ customer safety or licensing compliance or marketing authorization. The discrepancies shall be categorized as given below:

Critical Discrepancies:

Any discrepancies which have a direct impact on the quality of the product or safety of the consumer and any discrepancy which leads to batch rejection/ failure/ serious non-compliance to approved procedures shall be classified as a critical discrepancy.

These discrepancies shall be brought to the notice of Production Manager.

These discrepancies may arise from a failure to carry out GMP / GLP, etc. in some form or another.

All critical discrepancies observed shall be investigated or corrected in consultation with QA, QC and Production Manager titled as “Corrective and Preventive Actions” shall be referred for detailed CAPA for such cases.

The release of a batch shall be based on the investigation findings/ closure of CAPA/ corrective action and the final decision shall be taken by Manager Quality Assurance.

Major Discrepancies:

These discrepancies may or may not have direct impact on the quality of the product or customer safety or the licensing commitment or marketing authorization.

These can be rectified in consultation with QA, QC and Production Manger.

All major discrepancies observed shall be investigated or corrected in consultation with QA, QC and Production Manager. Any major deficiency prior to batch release.

Minor Discrepancies:

These discrepancies do not have direct impact on the quality of the product or customer safety or the licensing commitment or marketing authorization.

These can be rectified in consultation of the QA / Production / QC Manager.

QA Manager or QA Officer shall check the batch review checklist for any kind of critical or major or minor discrepancies.

If found acceptable, QA Manager shall release the batch for sale or distribution.

QA Manager while certifying a batch for release, shall ensure that the batch of the concerned product complies with the requirements of the product registration/ registration dossier/ marketing authorization/license and all other requirements regarding the manufacture, quality control and batch release of pharmaceutical products for sale.

The batch release shall be done through Enterprise Resource Planning (ERP) Batch Release Module.

Relevant Batch documents and Finished Product Analytical data and shall be archived in the document storage room under the custody of QA.

If the conditional transfer of a batch is required, production shall raise the “Conditional Batch Transfer Initiation Slip” 

The initiator shall provide the reason for the conditional transfer.

The request shall be approved by Production and QC Manager and shall provide the tentative date for the clearance of the batch.

Based on the reason for conditional transfer and the date provided QC Manager conditional transfer evaluated by Q.A Officer.

If approved, the consignment shall be transferred to warehouse.

The distribution of batches approved for conditional transfer shall be controlled by means of restricting the preparation of the sale invoice.

The process shall be controlled by QA Manager.

Following the clearance of batch from QC and completion of batch release procedure QA Manager shall “UNHOLD” the batch in the ERP/another Software module.

Conditional Release of Batch:

Conditional Transfer shall be permitted for batches manufactured and sold by the company for the Pakistan region only.

Products sold by another party (in Pakistan region) shall not be allowed for conditional transfer.

Conditional Transfer for such products shall be allowed through a planned deviation after approval from the contract giver.

Conditional Transfer is not permitted for products to be sent for export markets.

Transfer (conditional) for such products shall be allowed through a planned deviation after approval from the contract giver or distribution department where applicable.

Product recall shall be initiated in case of failure of a batch transferred on a conditional basis.