In this SOP the complete procedure of Packing of Products on a Packaging Line is described which is applied in the pharmaceuticals production section.
Packing of Products on a Packaging Line OBJECTIVE
1.1 To lay down the procedure for packing of a product on a packaging line.
SCOPE
2.1 The scope of this SOP applies to the procedure for packing of a product on packaging line in packaging section of production department.
3.0 RESPONSIBILITIES
3.1 It is the responsibility of Line Supervisor (packaging) to follow this SOP as it is written.
3.2 It is the responsibility of Packaging Pharmacist to ensure that this SOP is followed as it is written.
3.3 It is the responsibility of Production Manager to ensure that this SOP is followed in its entirety, reviewed and updated as necessary.
4.0 DEFINITIONS & ABBREVIATIONS
4.1 SOP: Standard Operating Procedure
4.2 BPR: Batch Processing Record
4.3 Q.A: Quality Assurance
4.4 F.G: Finish Goods
4.5 P.S: Physician Sample
PROCEDURE
5.1 Clear the packaging line as per SOP of line clearance.
5.2 Get the line clearance from Packaging Pharmacist and Q.A inspector on line clearance sheet.
5.3 Write the names of workers that are working on the line in “workers team layout sheet” of BPR.
5.4 Sort the blisters, bottles, labels, cartons and ampoules according to product specification.
5.5 Keep rejection material in rejection box.
5.6 Start working and pack products as per SOP.
5.7 Make the bundle of packs by checking the batch stamp and remove the packs having improper batch stamp.
5.8 Pack the bundles in shippers of respective product.
5.9 Transfer labels are attached on each shipper.
5.10 Finished packs are transferred to respective store (F.G & P.S) with transfer tickets.
5.11 Line supervisor calculates total labour hours at the end of the batch.
5.12 Packaging Pharmacist completes the BPR and calculates the % yield.