Siddhi Vinayak Industries.: Batch Manufacturing Record

SIDDHI VINAYAK INDUSTRIES.
Kh.No.339/183/46,vill.mouza johron,Kala Amb Tehsil Nahan (HP.)

BATCH MANUFACTURING RECORD Page |1
Product Name :-
Generic Name :-
Batch No:-
Batch Size :- Mfg. Date:-
Date of commencement:- Exp. Date:-
Sr. Ingredients Spec. Claim Unit Qty. Overage Qty. A.R.NO.

%
No Req. used
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Prepared By Checked By Approved By
Departmental Head Production Head Q.A/Q.C Head
Raw Material Weight by Issued By Raw Material Store Incharge

Product Name :-…………… ……... Batch Size:-…………….
Batch No. :-……………………
MFG. Date :-……………………. Exp. Date:-………………..
Date of Commencement: - …………………
CALCULATION:-
Quantity of Active Ingredient Added:-
Qty added = Standard Qty (100% basis) / Assay on it is Basis *100

(CLEANING CERTIFICATE)
Product Name :-…………… Batch Size:-…………….
Batch No. :-……………. Mfg. Date :-…………….
Exp. Date:-…………….
The Following Equipment And Machine Are Tested for Absence of Previous Batch/ Foreign Material.
Sr.
No. Equipments Previous Batch Batch No. Trace Amount Analyzed Checked
Available in By By
wash water
1 Sifter
2 Mass Mixer
3 Multi Mill
4 FBD/Tray Dryer
5 Granulator
6 Blender
7 Tablet
Compression M/C
8 Wt. Balance
9 Coating Machine
Blister/ Stripping
10 M/c
11 ALU ALU M/C
Observation & Results:
Signature Signature
(Production Dept.) (IPQA. / Q.C. Dept)
Batch No. :-…………….
Mfg. Date :-……………. Exp. Date:-…………….
Granulation- Section:-
Wet Granulation ( ) Dry Granulation ( )
Mixing:-
Date…………….. Time…………… Duration………….
Drying:-
Date…………….. Time……………. Duration………….
Actual Yield of Granules …………………………

Theoretical Yields of Granules……………………
Lubrication:-
Date………………. Time…………….. Duration……………
Actual Yield of Lubricated Granules ……………………

Theoretical Yields of Lubricated Granules………………
(Sign of Production officer/IPQC)
Uniformity of Mixing in Granules …………………
Date of Sample……………………………………..
Result……………………………………………….
(Sign of IPQC/QC)
(IN PROCESS CONTROL DURING COMPRESSION)
Product Name :-…………… Batch Size:-………………..
Batch No. :-…………….
Mfg. Date :-…………….. Exp. Date :-……………….
Compression:-
Compression Machines Used :-…………………………………
Punch Size :-…………………………………
Humidity :-…………………………………
Hardness :-…………………………………
Disintegration Time :- ………………………………..
Friability :-…………………………………
Average wt per tab :-…………………………………
Result of Analysis :-…………………………………
(Sign of Production Dept.) (Sign of IPQC)

(IN PROCESS CONTROL DURING COMPRESSION)
Batch No. :-…………….
Mfg. Date :-…………….. Exp. Date :-…………….

Weight Variation:
Weight of 20 Tablets: - Time:-

Average Weight: - Variation Weight Allowed (%) Max: - Min:-
Individual Weight of 20 Tablets: - R.H.S.
Deviation Observed Min (%):- Max (%):-
Weight of 20 Tablets: - Time:-

Average Weight: - Variation Weight Allowed (%) Min: - Max:-
Individual Weight of 20 Tablets: - L.H.S.
Deviation Observed Min (%):- Max (%):-
(Sign of Production Dept.) (Sign of IPQC / QC.)

Product Name :-…………… Batch Size:-……………..
Batch No. :-…………….
Date of Manufacturing :-…………….. Exp. Date :-……………
Date of Commencement: - …………….
Coating: - COATED / UNCOATED
Nature of Coating. 1:- Film Coating ( )
2:- Enteric Coating ( )
3:- Sugar Coating ( )
Colour of Tablets :-………………………
Name of Coater :-………………………
(Sign Of Production officer/IPQC)

Product Name :-…………….. Batch Size :-…………….
Batch No. :-…………….
Date Manufacturing :-……………. Exp. Date :-……………..
Date of Commencement: - ……………
Packing Material Requisition

Required Used Returned
Printed Foil
P.V.C.
Cartoons
C/Box
Issued By: - Received By:-

Name of Machine: - AluAlu ( ), Blister ( ), Strip ( )
Name of Operator …………………………
Attached Precoding of Packing Specimen
Leak Test: - Comply ( ) / Not Comply ( )
Date:- Start time:- Close time:-
Strip Checked By…………………….. Counting &Filling By……………………………

BATCH MANUFACTURING RECORD P a g e | 10
(Sign. Of Production /IPQC)
Product Name :-…………… … Batch Size :-…………….
Batch No. :-………………
Date Manufacturing :-……………… Exp. Date :-……………..
Date of Commencement: - ……………
ATTACHED SPECIMEN WITH CODING
(Sign of IPQA Dept.)

BATCH MANUFACTURING RECORD P a g e | 11
Product Name :-…………… Batch Size:-……………….

Batch No. :-…………….
Date Manufacturing :-…………….. Exp. Date:-……………….
Total Quantity Packed ………………………………………..

Qty. Collected as sample By Q.C.Deptt.:-…………………
Actual Yield……………………………………………………
Theoretical Yield ……………………………………………
Limits ………………………………………………………..
Q.C. Report of finished Product ………… (Attached)
Date of release……………………………………………………….
Date of Transfer of finish Product to Finished Goods …………..
Sign of production Sign of Q.C.

(Approved Person ) (Approved Person )

Siddhi Vinayak Industries.: Batch Manufacturing Record

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SIDDHI VINAYAK INDUSTRIES.

Kh.No.339/183/46,vill.mouza johron,Kala Amb Tehsil Nahan (HP.)

Sr. Ingredients Spec. Claim Unit Qty. Overage Qty. A.R.NO.

Departmental Head Production Head Q.A/Q.C Head

Raw Material Weight by Issued By Raw Material Store Incharge

Product Name :-…………… ……... Batch Size:-…………….

Batch No. :-……………………

MFG. Date :-……………………. Exp. Date:-………………..

Date of Commencement: - …………………

Qty added = Standard Qty (100% basis) / Assay on it is Basis *100

Product Name :-…………… Batch Size:-…………….

Batch No. :-……………. Mfg. Date :-…………….

Observation & Results:

Product Name :-…………… Batch Size:-…………….

Batch No. :-…………….

Mfg. Date :-……………. Exp. Date:-…………….

Date…………….. Time…………… Duration………….

Date…………….. Time……………. Duration………….

Actual Yield of Granules …………………………

Date………………. Time…………….. Duration……………

Actual Yield of Lubricated Granules ……………………

Product Name :-…………… Batch Size:-………………..

Batch No. :-…………….

Mfg. Date :-…………….. Exp. Date :-……………….

Compression Machines Used :-…………………………………

Punch Size :-…………………………………

Disintegration Time :- ………………………………..

Average wt per tab :-…………………………………

Result of Analysis :-…………………………………

(Sign of Production Dept.) (Sign of IPQC)

Product Name :-…………… Batch Size:-…………….

Batch No. :-…………….

Mfg. Date :-…………….. Exp. Date :-…………….

Weight of 20 Tablets: - Time:-

Individual Weight of 20 Tablets: - R.H.S.

Deviation Observed Min (%):- Max (%):-

Weight of 20 Tablets: - Time:-

Individual Weight of 20 Tablets: - L.H.S.

Deviation Observed Min (%):- Max (%):-

(Sign of Production Dept.) (Sign of IPQC / QC.)

Batch No. :-…………….

Date of Manufacturing :-…………….. Exp. Date :-……………

Date of Commencement: - …………….

Coating: - COATED / UNCOATED

Nature of Coating. 1:- Film Coating ( )

2:- Enteric Coating ( )

3:- Sugar Coating ( )

Colour of Tablets :-………………………

Name of Coater :-………………………

(Sign Of Production officer/IPQC)

Product Name :-…………….. Batch Size :-…………….

Batch No. :-…………….

Date Manufacturing :-……………. Exp. Date :-……………..

Date of Commencement: - ……………

Packing Material Requisition

Issued By: - Received By:-

Attached Precoding of Packing Specimen

Leak Test: - Comply ( ) / Not Comply ( )