Standard Operating Procedure of Redressing Approval in Pharmceuticals is describe in this post.
{getToc} $title={Table of Contents}
1. PURPOSE
To establish a procedure for redressing of the damaged products returned from the market or damaged in the premises of the manufacturer.
2. SCOPE
This SOP is applicable to all finished products, which are damaged during transportation or for any other reasons in Pharmaceuticals.
3. RESPONSIBILITY
3.1 FG Store Incharge is responsible to intimate QA Department for redressing approval with reason.
3.2 QA Officer is responsible for checking the product condition and verifying the quantity to be re-dressed.
3.3 QA Manager is responsible for assuring that verification is done.
3.4 Production Manager is responsible to conduct redressing of product.
4. MATERIAL & EQUIPMENT
4.1 Packing material
5. PROCEDURE
The product required to be redressed is mainly from two sources:
A. From market
B. Finally packed product damaged in the FG Store or factory premises.
Following steps will be followed for redressing
5.1 When the packaging damaged product come from any of the above source to the finished goods store, the store incharge (finished goods) will verify the quantities and identity (batch no. , product name, Mfg date, Exp date, price etc) of the product.
5.2 Store incharge will generate the “Redressing Approval Form” indicating the product name, batch number, Mfg date, Exp. Date, source and reason of redressing.
5.3 Store incharge will intimate QA department. QA personnel will verify the quantity, identity and condition of the product.
5.4 Store incharge will send “Redressing Approval Form” to QA Manager for final redressing approval.
5.5 After getting approval from QA Department Store incharge will send “Redressing Approval Form” to Production Department and Production Manager will forward it to related section head.
5.6 Section head will prepare an additional packing material order against that redressing approval.
5.7 After issuance of packing material the damaged packing of the returned product will be removed from packing section and repacked.
5.8 Related section head will intimate QA for Line Clearance for redressing and during packing QA and production officers will perform In-process checks.
5.9 All the documents of the redressing process “Redressing Approval Form”, Packing Material Issuance Form” and “Inprocess Packing Line Record” will be attached with BMR of the product.
5.10 Redressing will be done for the product damaged due to any reason which is within shelf life.
{getButton} $text={Download in Microsoft Office} $icon={Download} $color={Hex Color}