Professional Documents
Culture Documents
INDEX
S. PAGE
PARTICULARS
NO. NO.
1. STANDARD QUANTITY OF RAW MATERIALS 03
2. OPERATION DISPENSING 04
3. RAW MATERIALS DISPENSING SHEET / PRIMARY PACKING MATERIALS 05
DISPENSING SHEET
4. EQUIPMENTS REQUIRED/ OPERATION BATCH AMANUFACTUIRNG 06
5. BATCH MANUFACTURING PROCEDURE 07
6. TRANSFER OF BULK TO SS STORAGE VESSEL 08
7. OPERATION TUBE CLEANING / PROCEDURE FOR TUBE CLEANING / 09
OPERATION FILLING, SEALING, CRIMPING AND COLLECTION OF
TUBE
8. LINE CLEARENCE FOR TUBE FILLING 10
9. EMPTY TUBE WEIGHT RECORD 11
10. IN PROCESS FILL WEIGHT OF TUBE 12
11. COLLECTION OF TUBES 14
12. PACKING MATERIALS ISSUE 15
13. OPERATION PACKING / IN-PROCESS CHECKS 16
14. OVER PRINTING DETAILS / PACKING PROCEDURE 17
15. YIELD AND RECONCILIATION / RECONCILIATION STATEMENT 18
16. YIELD STATEMENT 19
17. SHIPPER WEIGHING RECORD 20
CONFIDENTIAL
A = ACTIVE
E = EXCIPIENT
CONFIDENTIAL
OPERATION DISPENSING
ENSURE:
1. Area is clean and line clearance is given by Q.A. Chemist (sign.) ………..
2. Balances are clean and calibrated with calibrated weight.
3. Equipment used in dispensing are clean.
4. Only "APPROVED" materials are issued following "FIFO SYSTEM".
5. All dispensed materials bear issue slips after dispensing.
6. Mask & gloves are used.
Composition :
Each gm contains :
Hydrocortisone Acetate USP 10 mg
Ointment Base q.s.
CALCULATION
If given quantity contains A.R. No(A)………………..
Assay of Hydrocortisone Acetate = ……………………….%(On dried basis )
LOD = ……………………….%
Assay of Hydrocortisone Acetate = ……………………….%(On as such basis )
S.
Weighed Weighed
No Ingredients Spf. Standard Qty. Ckd. By
A. R. No. Qty. By
.
HYDROCORTISONE
1. ACET USP 1.537 KG.
ATE
2. LIQUID PARAFFIN USP 12.000 KG.
3. WHITE BEES WAX USP 3.000 KG.
WHITE SOFT
4. USP 135.000 KG.
PARAFFIN
S.
Weighed Weighed
No Ingredients Spf. Standard Qty. Ckd. By
A. R. No. Qty. By
.
HYDROCORTISONE
1. ACET USP 1.537 KG.
ATE
2. LIQUID PARAFFIN USP 12.000 KG.
3. WHITE BEES WAX USP 3.000 KG.
WHITE SOFT
4. USP 135.000 KG.
PARAFFIN
EQUIPMENTS REQUIRED
S. Manufacturer and
Name of the Equipment Capacity Use
No. supplier
1. SS mixer with stirrer Kothari Pharma 200 kg. Mixing
2. Colloid mill Cadmach, Ahmedabad -------- Micronization
3. Automatic filling, sealing and Sanira Associates 30000 tubes / 8 Filling, sealing and
crimping machine Ahmedabad hours crimping
2. Charge White soft Paraffin, Liquid Paraffin and White bees wax.
After getting bulk release slip transfer bulk to packing department for filling
Date of transferring of cream to packing Dept.:______________
2 Is the area around the filling machine cleared of leftovers of previous batch
(Good / Rejected empty tubes ,left over bulk )
3 Is the coding block of previous product B.No. and manufacturing date and year
embossing dismantled & given to superior
4 Is the identification label of the previous product removed
5 Is the floor cleaning done before start up of
EQUIPMENT TAG NO
Set the machine for the batch coding on the crimp of tube coding .As will paper on the crimp of tube
________________. The batch coding dotard on tubes have been verified & found correct.
Actual coding on crimp of tubes _________________________________
Checked By Production supervisor Date Time
Attached coded tubes ( one for each head of the filling machine at the time of start and completion of filling
CONFIDENTIAL
Date / Tare
Gross wt. Net wt. Remarks Tare wt. Gross wt. Net wt. Remarks Ckd. By
Time wt.
CONFIDENTIAL
Date / Tare
Gross wt. Net wt. Remarks Tare wt. Gross wt. Net wt. Remarks Ckd. By
Time wt.
COLLECTION OF TUBES
Total
Operators: ………………………………...
Production Supervisor:……………………
(Name and signature)
CONFIDENTIAL
OPERATION: PACKING
LINE CLEARANCE:
Previous product ……………………………………………. Batch No. ……………………..
1. The area is clean.
2. Line clearance is given by Q.A (Sign.) ……………………..
IN-PROCESS CHECKS:
Date Initial Printed Carton Last Printed Carton Operator Supervisor Q.A.
Date
Time
Specimen:
PACKING PROCEDURE
PROCEDURE:
YIELD STATEMENT