i. Compounding:
Check List:
1.
Area Temp, RH,
DP
2.
Area & Equipments Cleanliness & Removal
of Previous Product things
3.
CIP & SIP – Rinse Water Reports
4.
Integrities of Hydrophobic & Hydrophilic Filters
5.
Calibration of pH, Conductivity meters, Weighing Balance
6.
Availability of Hose Pipes, Silicone pipes
7.
Availability of Steam, Compressed Air/Nitrogen,
Chilled Water
8.
Availability of Measuring Cylinder, Glass wares
9.
Calibration Labels with-in Due Date
10.
Integrity of vent Filter with-in Due date
11.
Preventive Maintenance Status
12.
Updation of All details ON-LINE in Log-Books
13.
Receivable Raw-Materials from WH & Weight verification.
14.
Procedure Followed As Per SOP & BMR
ii.
Warehouse:
Check List:
1.
Area Temp, RH,
DP
2.
Area & Equipments Cleanliness & Removal
of Previous Product things
3.
Calibration of Weighing Balance &
Calibration Labels with-in Due Date
4.
Preventive Maintenance Status
5.
Updation of All details ON-LINE in Log-Books
6. Verification
of QC-Approved Label, Item code, Lot No., A.R.No of Raw material, API, Primary,
Secondary packing Materials
7.
Dispensing Procedure Followed As Per SOP
iii. Autoclave:
Check List:
1.
Area Temp, RH,
DP
2.
Area & Equipments Cleanliness & Removal
of Previous Product things
3.
Availability of Steam, Compressed Air, Strip
chart.
4.
Calibration Labels with-in Due Date
5.
Integrity of vent Filter with-in Due date
6.
Preventive Maintenance Status
7.
Updation of All details ON-LINE in Log-Books
8.
Load-Pattern Procedure Followed As Per SOP
iv. Washing &Tunnel:
Check
List:
1.
Area Temp, RH,
DP
2.
Area & Equipments Cleanliness & Removal
of Previous Product things
3.
Calibration Labels with-in Due Date
4.
Preventive Maintenance Status
5.
Updation of All details ON-LINE in Log-Books
6.
Change Parts & Recipe selection
7.
Availability of WFI, Compressed Air
8.
Check the pressure of WFI, Re-Circulated water,
Compressed Air.
9.
Check the Availability of Strip chart
10.
Tunnel Conveyer speed & Washing Machine Recipe
11.
Washing, De-Pyrogenation Procedure Followed As
Per SOP
v. Filling:
Check List:
1.
Area Temp, RH,
DP
2.
Area & Equipments Cleanliness & Removal
of Previous Product things
3.
Check ON-LINE particle machine should be on
condition
4.
Micro-Monitoring
5.
Integrities of Hydrophobic & Hydrophilic Filters
6.
Availability of Sterilized items of Garments,
Filling Change Parts, Filling Items, SS items
7.
Calibration Labels with-in Due Date
8.
Preventive Maintenance Status
9.
Updation of All details ON-LINE in Log-Books
10.
Receivable of Filtered Solution from compounding
11.
Filling Machine Recipe, Fill volume set-up & verification
12.
Procedure Followed As Per SOP
vi. Sealing:
Check List:
1.
Area Temp, RH,
DP
2.
Area & Equipments Cleanliness & Removal
of Previous Product things
3.
Calibration Labels with-in Due Date
4.
Preventive Maintenance Status
5.
Updation of All details ON-LINE in Log-Books
6.
Sealing Machine Recipe, Sealing verification
(Crimping, Dentate, Flip-off, Seal colour, Tightness)
7.
Procedure Followed As Per SOP
vii. Terminal Sterilization:
Check
List:
1.
Area & Equipments Cleanliness & Removal
of Previous Product things
2.
Availability of Pure-Steam, Purified Water,
Compressed Air, Strip chart.
3.
Calibration Labels with-in Due Date
4.
Preventive Maintenance Status
5.
Updation of All details ON-LINE in Log-Books
6.
Load-Pattern Procedure Followed As Per SOP
viii. Lyophilizer:
Check List:
1.
Area & Equipment’s Cleanliness & Removal
of Previous Product things
2.
Availability of CIP, SIP, History data &
Vacuum leak test data and Integrity data
3.
Calibration Labels with-in Due Date
4.
Preventive Maintenance Status
5.
Check the Lyophilizer recipe
6.
Updation of All details ON-LINE in Log-Books
i. Packing:
Check List:
1. Area Temp
2. Area & Equipments Cleanliness & Removal of Previous Product things
3. Calibration Labels with-in Due Date
4. Preventive Maintenance Status
5. Updation of All details ON-LINE in Log-Books
6. Receivable Materials from WH
7. Visual/Optical inspection – Low volume, High volume, White, Black, Fiber, Glass, seal rejections, others.
8. Label Physical Verification, Labeling, Packing & weight checking
9. Collection of Control, Stability Samples, Others sample after Packing
10. Finally Transfer of Packing Materials /Finished goods to Warehouse
11. Procedure Followed As Per SOP
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