Returned Finished Products Disposition, Purpose :
Returned Finished Products Disposition, The objective is to specify a system to handle the returned finished products for their appropriate and adequate review and disposition in line with the Quality Management System.
Returned Finished Products Disposition, Scope :
This procedure is applicable for disposition of returned finished products and expired ones at XX Pharmaceuticals Limited. (Both General & Cephalosporin Block).
Definitions / Abbreviation:
[][]QA : Quality Assurance
[][]DIC : Depot In Charge
[][]XX : Current Version of SOP
Responsibilities:
[][]The roles and responsibility is as follows:
Head of Distribution
[][]Head of distribution shall collect the finished products from different depots and forward to the central warehouse for final disposition as per procedure.
Depot In Charge (DIC), Central Warehouse
[][]To verify, receive and separately quarantine the returned goods.
Executive, QA
[][]Responsible for effective implementation and monitoring of procedure.
Senior Executive, Cost & Budget (Factory)
[][]To verify all the returned products and make report for stock adjustment memo.
Head of Plant Operation
[][]Follow-up of overall activities.
Head of Quality Assurance
[][]Approval of all the disposition activities.
Procedure:
[][]The returned finished products shall either be destroyed or repacked and made fit for use depending upon the reason for which they have been returned. In either case, the associated risks must be well understood and addressed.
[][]Hence the procedure for disposition of returned finished products is defined depending upon the reason for which products are returned.
[][]Head of Distribution will collect the finished product as per requirement from different depots and send to Central warehouse following the Invoice/ Challan.
[][]On receipt of the products, warehouse (Central) In Charge or designee shall verify the products as per Invoice / Challan. Then warehouse in-charge will label the products to identify the primary cause of return and segregate the returned products in the respective area.
[][]Quarantine the products in area as per classification and inform QA and Head of Plant Operation through Returned Finished Product Note, (Annexure – I).
[][]Reference number for Returned finished products shall be alphanumeric system containing 7 characters. Numbering breakdown is as follows : RG/YY/001
For example : RG/XX/001
=>The first two alphabets shall stand for Returned Goods
=>Next two numeric characters shall stand for year code XX shall denote year 20XX.
=>Next character is followed by three numerical shall stand for serial number, which shall start every year
from 001.
[][]All the expired products returned from the market shall be directed and received at the distribution Department and these shall be destroyed in presence of QA Executive following the SOP of Procedure for Disposal of Materials & Products.
[][]QA Executive shall prepare Authorization and Disposal From for Materials & Products and take authorization for disposal activities.
[][]Head of Quality Assurance or designee shall arrange to verify the reason for return/ recall of the returned products against the intimation.
[][]If the returned products (except expired products) which are fit for further use they shall be repacked through repackaging request form following the Reprocessing/reworking and Repackaging Procedure.
[][]Quality Assurance personal shall examine the products returned because of dirty labeling, packed damaged products can be repacked. To ensure the product quality, QA executive shall draw the sufficient sample for complete analysis (If necessary) and only if found satisfactory and certified accordingly, then the batch shall be allowed for repacking.
[][]For the repackaging activities minimum five unit packs are required for the returned product of same batch no. Less than five unit pack of a same batch shall be disposed following the disposal SOP.
[][]The returned products except expired products which can be repacked to be sent from central warehouse to the manufacturing site and shall be classified and stored separately depending upon the primary cause of return.
[][]Record for issue of packaging material, overprinting and packing shall be maintained on Additional Batch Packaging Record (Primary/Secondary) along with the Repackaging Request Form authorization by Head of Quality Assurance.
[][]If the returned products in the opinion of the Quality Assurance personnel are not considered fit for repackaging, the same shall be destroyed after approval from Head of Quality Assurance.
[][]This repacked part shall be released after compiling of the all related documents and shall be attached to the earlier batch record (BMR/BPR)
Products recalled voluntarily or recalled, as per the directives from Drug Control Authorities the recalled products shall be handled depending upon the reason for product recall; they may be require to be destroyed or repacked.
Annexure:
Annexure I – Returned Finished Product Note