Procurement, Receipt and Handling of packing Change parts

 In this post Standard Operating Procedure of Procurement, Receipt and Handling of packing Change parts in Pharmaceuticals is describe.

1.0   OBJECTIVE:

To lay down the procedure for procurement, receipt and handling of packing change parts.

2.0   SCOPE:

This SOP is also applicable for procurement, receipt and handling of packing change parts.

3.0   RESPONSIBILITY:

Production: Officer /Executive/ Manager

Head Production: To ensure execution & compliance. Head QA: To ensure the compliance.

4.0   PROCEDURE:

4.1   Procurement of Packing Change Parts:

4.1.1  Packing change parts shall be procured from vendor on approved product packaging layout 

only.

4.1.2  Vendor shall provide layout after receiving requirement from production machine wise

4.1.3  Production shall give all information about packing of product after discussion with Product 

research & Development to vendor for layout of new product.

4.1.4  Sample of Dummy tablets/capsules also provide to vendor if needed.

4.1.5  Layout shall be received by production, checked and approved by both production and Product 

research & Development, then shared to vendor for quotation.

Production shall raise indent in ERP once quotation received from vendor and Purchase Order

4.1.6  shall be raised by purchase.

4.2   Receipt of Packing Change Parts:

4.2.1  Check & ensure packing change parts received from vendor is as per indent and Purchase 

Order.

4.2.2  Ensure all packing change parts are free from damage when receiving.

4.2.3  Keep packing change parts as per Rack wise, layout wise, product wise in change parts 

cabinet.

4.2.4  Label the Shelf in rack about Layout/product information.

4.3   Handling of packing change parts:

4.3.1  Production officer/executive shall ensure packing change parts like BFR,CSR, Punching tool,

Guide track, Feeding channel, SS bowl, SS chute, sealing roller, Upper and lower forming pattern, 

Upper and lower sealing pattern, Indexing roller, Feeder box are free from damage, cleaned, shrink 

wrapped and kept in rack as per product wise and layout wise.

4.3.2  Production officer/executive shall issue packing change parts after confirming Product and 

change part layout from BPR to concerned Technician and make entry in packing change parts inward / 

outward record (Annexure I).

4.3.3  Technician shall take the change part to the concerned primary cubical, then set the machine 

and continue machine operation as per its operation and cleaning SOP.

Technician shall dismantle the change part and clean it with dry lint free cloth and then shrink

4.3.4  wrap it after batch is completed in machine.

Production officer/executive shall receive packing change parts from Technician and make entry

4.3.5  in packing change parts inward / outward record (Annexure I).

Production officer/executive shall ensure that received packing change parts shall kept in 

respective rack product wise and layout wise.

4.3.6  In case of packing change parts has to receive from other location / outside the respective 

packing area then place  it in change part rack with shrink wrap and repeat the step 4.3.1 to 4.3.6 

for

4.3.7  handling of packing change part.

5.0   ANNEXURE (S):

Annexure – I: Packing Change Parts Inward/Outward Register.

6.0   REFERENCE (S):

Nil.

7.0   ABBREVIATION (S) /DEFINITION (S) :

QA: Quality Assurance

SOP : Standard Operating Procedure

BFR : Blister Forming Roller

CSR : Counter Sealing Roller

ERP :Enterprise Resource Planning