sop for for De Cartoning of Ampoules
1.0 OBJECTIVE:
To lay down a Procedure for De-Cartoning of Ampoules.
2.0 SCOPE:
This SOP is applicable for De-Cartoning of Ampoules in Production area
3.0 RESPONSIBILITY:
Officer / Executive – Production
4.0 ACCOUNTABILITY:
Head – Production
5.0 PROCEDURE:
5.1 PREREQUISITES:
5.1.1 If any shipper observed with broken Ampoules that shipper shall be used after 100% physical verification of vials.
5.2 Ensure that vials boxes are clean and free from dust.
5.3 Verify the quantity and size of Ampoules as per Batch Manufacturing Record (BMR).
5.4 Remove shrink wrap or strapping from the box.
5.5 Shipper, box to be open by removing adhesive tape.
5.6 Take out the Ampoules from the Shipperor box and kept on inspection table under illuminated light to inspect
physical defects (mold defect , black partical ,scratch in surface , broken Bottom
/broken neck) and kept in pigeon hole rejection box under lock and key condition and good Ampoules to be transfer
for washing process with the help of SS plate.
5.7 After completion of De- Cartoning activity all Rejected Ampoules to be count in the present of Production and IPQA Officer and
record the detail in Annexure-I, Titled as “Log of De- Cartoning Ampoules”.
6.0 ABBREVIATIONS:
SOP : Standard Operation Procedure
WFI : Water for Injection
Ltd. : Limited
No. : Number
QA : Quality Assurance
UV : Ultraviolet Light
IPQA :In-Process Quality Assurance
BMR : Batch Manufacturing Record
SS : Stainless Steel
7.0 ANNEXURES:
ANNEXURE No. TITLE OF ANNEXURE
Annexure- I Log of De-Cartoning Ampoules
Annexure- II Type of Defective Ampoules
8.0 DISTRIBUTION:
Controlled Copy : Production Department
Master Copy : Quality Assurance
9.0 REFERENCES:
In House
ANNEXURE – I
LOG OF DE-CARTONING AMPOULES
Annexure- II
Type of Defective Ampoules
