Spot Checking of finished Goods

1.0 OBJECTIVE 

1.1 To define a procedure for spot check of finished goods to ensure correctness of labeling, packing and quantity packed, before transfer of packed shippers to ware house.

2.0 SCOPE 

2.1 This procedure is applicable for all the finished products packed at Company Name 

3.0 RESPONSIBILITY  

3.1IPQA Chemist 

4.0 ACCOUNTABILITY   

4.1 In Charge – Quality Assurance 

5.0 PROCEDURE 

5.1 IPQA chemist shall select 5% of the packed shipper for spot check before transfer of each FGTR to ware house. 

5.2 Finished goods spot-checking shall be performed as follows.

5.2.1 Open the packed shipper by removing BOPP tape.

5.2.2 Inspect vials / Ampoules / Pre filled syringes for the following.

(a)Proper sealing

(b)Proper labeling.

(c)Volume of the Solution.

(d)Correctness of quantities in an inner box/outer box

(e)Correctness of over printing details and quality of overprinting on vials/ampoules/PFS/cartons

5.3 Cartons and Shippers should be observed for proper labeling and packing quantity per carton/shipper.

5.4 In case any deviations are observed, they shall be immediately informed to Incharge -QA

5.5 Spot check shall be recorded in Format and attached to the BPCR.

 6.0 ANNEXURE 

 Annexure I – Spot Check Record Of Finished Goods

7.0  Change History