In this blog we come to know how to retaining of sample of finished Goods in pharmaceuticals industry.
Retaining Of Sample Of Finished GoodsOBJECTIVE
1.1 To lay down the procedure for retaining of sample.
2.1 The scope of this SOP applies to the procedure for retaining of sample of a product from packing line in packaging section of production department.
3.1 It is the responsibility of Line Supervisors (packaging) to follow this SOP as it is written.
3.2 It is the responsibility of Production Pharmacist (packaging) 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.
DEFINITIONS & ABBREVIATIONS
4.1 SOP: Standard Operating Procedure
4.2 BPR: Batch Processing Record
4.3 Q.C.D: Quality Control Department
5.0 MATERIALS & EQUIPMENTS
6.1 Designated person collect reference samples of each batch (quantity sufficient for at least three complete analysis for that product) from packing line with the intimation to the Production Pharmacist.
6.2 Production Pharmacist takes signature of a person, collecting reference samples in production record and also ensures that samples from every batch are submitted to QCD.
6.3 Production Pharmacist mentions sample submission in BPR for reconciliation purpose.
6.4 Samples are physically checked for Product name, Batch number, Manufacturing date, Expiry date and Registration number, on cartons and labels.
6.5 Then samples are received in Q.C.D and entered in Log Register with information of Product name, Batch number, Manufacturing date, Expiry date, Registration number and other required information.
6.6 Samples are kept in Sample Retention Room in a sequence with other samples, to make it easy for retrieval.
6.7 Retention times for samples are till expiry date, plus one (1) year after expiry.