SOP

  1. 1. Objective:

To lay down a procedure for repacking of finished products.

  1. Scope:

This procedure is applicable for repacking activities of finished products to be carried   out at factory premises.

  1. Responsibility:

Production, warehouse, quality control and quality assurance

  1. Procedure:

4.1 Regulatory and GMP consideration:   

4.1.1 Ensure if repacking is allowed by concern regulatory agency.

4.1.2 Review the submitted dossier/ regulatory submission of subject product if required. Consideration shall be given if concern regulatory agency approval required for repacking activity.

4.1.3 Product manufactured for semi regulated or domestic market shall not be repacked for regulated market.

4.1.4 Planned deviation shall be raised for repacking and impact assessment shall be         performed.

4.1.5 Repacking plan/procedure shall be proposed in written before start of the activity     and shall be approved by production, warehouse, quality control and quality       assurance department.

4.1.6 New proposed shelf life (if any) of repacked products shall be based on available       stability data and notify regulatory agency wherever required.

4.2 Initiation of repacking:

4.2.1 Transfer the goods in quarantine area and record the quantity to be repacked.

4.2.2 Withdraw the samples and send to QC laboratory for analysis if required.

4.2.3 If product complies with specification then release for repacking. Reject if it does not comply with the specification.

4.3 Repacking activity:

4.3.1 Take line clearance from IPQA.

4.3.2 Transfer the product to be repacked in packing hall.

4.3.3 Open the shippers and remove the inners/ unit cartons.

4.3.4 Remove the product container, insert, measuring device etc. from inners/unit cartons.

4.3.5 De-blister the product if it is packed in blister pack. De-blistering is allowed in cases where blister pack contains primary packed units like ampoules, vials etc.

4.3.6 De-blistering is not allowed for tablets and capsules etc., which are not packed in blister with primary container.

4.3.7 Remove the label (if any) from container by peeling off and clean it by IPA          mopping.

4.3.8 Remove all packing materials from packing hall and destroy in presence of IPQA. Record the quantity destroyed.

4.3.9 Keep damaged units (if any) in segregated area with status label and destroy at the end of the activity.

4.3.10 Calculate the final quantity to be repacked.

4.3.11 Record above activity in repacking from.

4.3.12 Issue new batch packing record as per requisition for repacking of product.

4.3.13 Issue required quantity of packaging materials from warehouse.

4.3.14 Take line clearance from IPQA and perform the repacking activity as per new BPR.

4.3.15 Collect necessary samples during repacking activity.

4.3.16 After completion of repacking, retain both new and old BPR.

  1. Abbreviations:

GMP: Good Manufacturing Practices

QC: Quality control

IPQA: In process quality assurance

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