Handling of Returned Pharmaceutical Products
OBJECTIVE :
To establish a procedure for the Inspection and Handling of Returned Drug Products.
RESPONSIBILITY :
Head – Warehouse to inform Head QA about the product returned.
Officer Warehouse to identify the product returned, against documents received and to verify the physical conditions of the received drug product.
Officer QA to inspect & sample the returned drug product.
Officer QC to analyse the sample.
Head QA to decide the disposition of returned drug products
PROCEDURE :
While receiving a lot of returned Drug Product Officer-Warehouse shall identify the returned lot by name of the product, batch No., Exp. date against the received documents, and shall check the following:
The specified reasons for return of Drug Product.
Customer Name and address who returned the product.
Physical condition of all the containers, and note the number of damaged containers and inform warehouse manager.
Quantity of shippers received and mentioned in return documents.
Integrity of seal on each container/shipper .
After verification, the returned product shall be unloaded and quarantined in the finished goods Warehouse and labelled as “Returned Product” on each container/shipper.
The details of returned product shall be recorded in ‘Returned Product Form’ (Annexure-2) in duplicate, signed and forward to Warehouse Manager.
Manager – Warehouse shall write his comments and forward a copy of RPF to Head – QA.
Head – QA shall review the reasons for return and shall advise on the action regarding its disposal / destruction /reprocessing depending upon the nature of the status of the returned product.
If the returned product is to be destroyed, it shall be assigned for appropriate disposition.
If the returned lot of the product is suitable for further evaluation, the QA- Head shall assign a QA Officer to :
Inspect the lot against the details mentioned in RPF, return documents and note the deviations.
Open the shippers/containers at random and inspect the integrity of the immediate container/closure.
Compare the visual description of the product as per specifications.
Segregate the damaged bottles and shippers containing bottles with physically non conforming tablets/capsules.
Randomly collect samples from the returned lot and put the label “QA Hold” (Annexure -1) on each container/shipper.
Send the request along with sample, to Manager – QC for testing as per Standard Test Procedure (STP) effective when the product was initially released.
Fill the Inspection Report of returned Drug Products.
Note : Sampling plan, amount of sample and type of sample (individual/pool sample) is determined by QA officer, case by case, upon consultation with Head – QA.
QC officer shall analyse the sample, as per the STP effective when the product was initially released. Prepare the analysis report and submit to QC .
QC with his remarks (Conforms/does not conform) shall forward the analysis report to Officer – QA.
Officer – QA shall compare the results of each test with the results of initial release, and also verify the stability results of the corresponding period for that product (if any).
Officer-QA shall complete the Inspection report of drug product and submit to Head – QA.
Head – QA shall declare the lot or portion of the lot as acceptable for commercial distribution after reviewing the testing/inspection reports.
Forward a copy of Inspection report of return drug product to Warehouse Manager.
If approved for distribution QA officer shall remove the QA Hold Label and affix Approved Label (annexure-1) on each shipper/container of the lot.
If the lot is rejected, the drug product shall be disposed appropriately as per the relevant Standard Operating Procedure(SOP)
The RPF., Analysis report, shall be filed in the Batch Production Record of respective product.
Forms and Records (Annexures)
Specimen labels of “Returned Product”, “QA Hold” and “Approved”.
Specimen format of “Returned Product Form”.
Specimen format of “Inspection Report of Returned Drug Product”.
Distribution
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control.engineering
History
| Date | Revision Number | Reason for Revision |
| – | 00 | New SOP |
Annexure 1
Specimen labels of “Returned Product”, “QA Hold” and “Approved”
- RETURNED PRODUCT
- Product:
- Batch / Lot No.:
- Expiry Date:
- No. of Containers/
- Shippers Returned
- Signature / Date:
- QA HOLD
- Product:
- Batch / Lot No.:
- Expiry Date:
- Sampled On:
- Container No.:
- Signature / Date:
Annexure 2
Specimen format of “Returned Product Form”
RETURNED PRODUCT FORM
- Product Name :
- Batch /Lot No.:
- Expiry Date :
- Returned By:
- (Customer Name & Address)
- Quantity Returned:
- Quantity Received:
- Received Date:
- Reasons for Return
- No. of Containers/Shippers Received :
- No. of Damaged Containers/Shippers :
- Comments of Warehouse Officer :
- Officer Ware House (Sign.) :
- Comments of Warehouse Manager:
- Warehouse Manager (Sign.) :
Annexure 3
Specimen format of “Inspection Report of Returned Drug Product”
INSPECTION REPORT OF RETURNED DRUG PRODUCT
Product Name:_______________Batch /Lot No.:__________________________Expiry Date :__________________
- Item Checked
- Details of the returned drug product as per Return Documents are tallying with that mentioned in RPNF.
- The physical condition of shippers/containers is satisfactory
- All the shippers/containers are labeled with a “Returned Product” label.
- Damaged shippers/ containers are segregated separately. (mention the number of damaged shippers/containers in remarks)
- The physical description of the product conforms to the specifications
- Any evidence of contamination in transit was observed.
- The integrity of the immediate container/closure was found satisfactory
- QA Hold label affixed on containers/ shippers
- Total No. of Containers / Shippers returned:
- No. of Containers/ Shippers opened:
- Quantity of Sample collected:
- QC Results tallying with results of initial results:
- Comments of Officer – QA :
- Lot Disposition
- Quantity approved for distribution :
- Quantity Rejected:
- QA Head (Sign.):
