MASTER FORMULA CARD
MASTER FORMULA CARD NO.
NAME OF PRODUCT.
BOOK REF.
DOASE.
INDICATION.
BATCH SIZE.
BATCH WEIGHT.
EFFECTIVE FROM.
SELF LIFE.
PREPARED BY. CHEKED BY. APPROVED BY.
MASTER FORMULA.
Sr.No. Item Name Botanical Name. Book Part Quantity.
Ref. Used.
REQUISTION FORM
No:-
To Store Keeper
Please Issue Following Raw Material As Per Details Given Bellow.
NAME OF PRODUCT
Batch No.: Batch Size: Mfg Date:
Sr. Ingredient Qty. Batch A.R.No. Issued Checked By Remark
No. Req.In. No. Weight
STORE Chemist
Kg. Kg. KEEPER
Please Receive Above Materials Receive Above Materials
Sign. Of Store In Charge Sign. Of Q.C. Chemist
STANDARD OPERATING PROCEDURE
Title: MANUFACTURING PROSIDURE FOR TABLET PRODUCT
Department: Quality control SOP No:
Effective Date: Pagge No:
Prepared By: Checked By: Authorized By.
(Q.C.Manager) (Director Technical)
PERSONNEL HYGIEN MACHINE CLEANING RECORD
Dept:- Date:- Date:-
. Shift:- Shift:-
Machine :-
Checked : Absence of p.p. Reminants Yes/No. Yes/No.
Cleaned: Machine parts Yes/No. Yes/No.
Done by:
Tag Status :
Checked by :
Remark:
Name of previous product :
Name of new product :
Check points for m/c clearance & cleaning : Absence of powder,broken pieces of tab. Rejected Tab./Cap.,
Broken pieces of E.H.G. capsules.
M/C PART : Hopper,bowl, Die punch,feed frame,stud gear,m/c body etc.
Area : Surround area of the m/c
Cleaning procedure : Cleaning of the machine done twice/shift twice clean dry cloth and at the time of product
change over all the stainless steel parts of the clean with wet cloth followed by clean dry cloth.
PERSONNEL HYGINE
1. Is there any person without uniform, hand gloves, mask, sleeper etc? Yes/No.
2. Is there any person with long nail, eared, opened hair, and contaminated nail? Yes/No.
3. Is there any person with jewellery, wrist watch, belt lather pocket? Yes/No.
4. Is there any person with eye, mouth dieses? Yes/No.
5. Is there any person wounded or having wound with bleeding? Yes/No.
6. Is there any unnecessarily movement in manufacturing/filling/packing area? Yes/No.
7. Show the SPO for above check points. Completed/updated
Production Chemist
LIST OF EQUIPMENTS:
Sr.No. Name of Equipments Sr.No. Name of Equipments
1. Masa Mixture 8. Weight Balance
2. Shifter Machine 9. Friability Test Apparatus
3. Kharal 10. Hardness Tester
4. Drier 11. Thickness Tester (Varniyar Calipers)
5. Multimill/Granulator 12.
6. Tablet Compression M/C. 13.
7. Dia & Panch 14.
INPROCESS CONTROL DURING GRANULATION :-
SAMPLING ON. SAMPLED BY.
SR.NO. TEST SPECIFICATION RESULT REMARK
1. Description.
2. Moisture
3. Bulk Density
4. % of Fine Powder
5. % of Granules
6.
WEIGHT VARIATION OF TABLET.
Sr.No. Net.Weight of Each Tablet Sr.No. Net.Weight of Each Tablet
1. 11.
2. 12.
3. 13.
4. 14.
5. 15.
6. 16.
7. 17.
8. 18.
9. 19.
10. 20.
PACKING MATERIAL FORMULA:-
Sr.No. NAME OF PACKING MATERIAL REQUIRED QUANTITY
1. ALLUMINUM FOIL
2. PVC BLISTER/PLAIN ALLIMINUM FOIL
3. CARON
4. CATCH COVER
5. CELLO TAP
6. BOPP TAP
7. CORRUGATED BOX
8. OUTER LABLE (TO/FROM/MATTER)
9.
INSTRUCTION FOR PACKING OPERATION:-
1. Check the printed Al. Foil for Product Name, Batch No., and Mfg.Dt. & M.R.P.
2. Before starting stripping & packing label, cartons, printed Al. Foil & catch cover should be
approved by Q.C /Q.A Dept.
3. Check line clearance
4. Inspect visually the empty packed strip send the sample to Q.C for leak tested.
5. Keep cartons or catch cover in shipper or duplex and stitched one label out side.
IN PROCESS CHECKING DURING PACKING OF PRODUCT.
PRODUCT NAME. PACKING SIZE.
BATCH NO. PACKED QTY.
MFG.DT.
EXP.DT.
Sr.No. Time Description of Tablet Colour printing, Coding OG foil Room temp./Humidity
Knurling sealing Empty open pocket Broken Tablet Printing coding of
carton/Label
Quantity packed Shipper quantity Remark Sign.
