Master Production Record

MPR #:

5503

Product Code:
Chewable Vitamin C

Drug Name:
Chewable Vitamin C Tablets

Strength:
250 mg

Number:
147 1

Cover Page
Manufacturing Date: Author: Theoretical Yield: Purpose: Formulation Id:

Sam Ops 1050 kg Production for Distribution

Batch Size: MPR Version #: Scope:

5503 105000.000 23 ea 1 Commercial Supply in North America

Bill of Materials
Part Ver Material Qty/Batch Unit Composition Unit

158 159 160 161 162 163 164 165 166 167

1 1 1 1 1 1 1 1 1 1

DIPAC F.D. & C. Yellow #6 F.D. & C. Yellow #3 Orange Flavor Orange Juice Oil OilVeltol Vanillin Candex Sodium Ascorbate Ascorbic Acid

477.48 6.72 0.63 10.10 0.34 0.11 2.63 196.88 259.64 59.23

kg kg kg kg kg kg kg kg kg kg

Equipment
Equipment #: Equipment Name

PK001 PK010 TP16

2 Cu. Ft. V Blender 10 Cu. Ft. Twin Cone Blender Manesty Beta Press Rotary Tablet Press, 16 station

In-Process Testing
Step Test Method Purpose Specifications

MPR Approvals
Approver Job Function Date/Time

KWagner01

Production Supervisor

Master Production Record

MPR #:

5503

Product Code:
Chewable Vitamin C

Drug Name:
Chewable Vitamin C Tablets

Strength:
250 mg

Number:
147 1

Manufacturing Instructions
Step Material Action: Inventory: Step Material Action:

100.00 WEIGHING
Performer: Part: Target:

0
Verifier:

Ver.

101.00 Weigh two portions of DIPAC of 75.000 kg each and one portion of 327.478 kg
Performer:

0 477.48 Range: 477-478

Part: Target: Verifier:

Ver.

Inventory: Step Material Action: Inventory: Step Material Action: Inventory: Step Material Action: Inventory: Step Material Action: Inventory: Step Material Action: Inventory: Step Material Action: Inventory: Step Material Action: Inventory: Step Material Action: Inventory:

102.00 Weigh out 6.72 kg of F.D. & C Yellow #6

Performer:

0 6.75 Range: 6-7

Part: Target: Verifier:

Ver.

104.00 Weigh 10.101 kg of Orange Flavor S.D.

Performer:

0 10.101 Range: 10.0-10.2

Part: Target: Verifier:

Ver.

105.00 Weigh out 0.63 kg of F.D. & C. Yellow 3

Performer:

0 0.63 Range: 0.60-0.65

Part: Target: Verifier:

Ver.

107.00 Weigh out 0.340 kg of Orange Juice Oil

Performer:

0 0.340 Range: 0.33-0.35

Part: Target: Verifier:

Ver.

108.00 Weigh out 0.105 kg of OilVeltol Plus

Performer:

0 0.105 Range: 0.100-0.110

Part: Target: Verifier:

Ver.

109.00 Weigh out 2.625 kg of Vanillin

Performer:

0 2.625 Range: 2.620-2.630

Part: Target: Verifier:

Ver.

110.00 Weigh out 196.875 kg of Candex

Performer:

0 196.875 Range: 196-197

Part: Target: Verifier:

Ver.

120.00 Weigh out 259.644 kg of Sodium Ascorbate

Performer:

0 259.644 Range: 259-260

Part: Target: Verifier:

Ver.

Master Production Record

MPR #:

5503

Product Code:
Chewable Vitamin C
Step Material Action: Inventory: Step Material Action: Inventory: Step Material Action: Inventory: Step Material Action: Inventory: Step Material Action:

Drug Name:
Chewable Vitamin C Tablets

Strength:
250 mg

Number:
147 1

130.00 Weigh out 59.231 kg of Ascorbic Acid

Performer:

0 59.231 Range: 59-60

Part: Target: Verifier: Part: Target:

Ver.

200.00 0
Verifier: Part: Target: Performer: Ver.

BLENDING
Performer:

210.00 0
Verifier: Part: Target: Ver.

Preblend #1 211.00

Ver.

Load 75 kg DIPAC into suitable blender

Performer:

Verifier: Part: Target:

212.00 0
Ver.

Pass the F.D. & C. Yellow 6, F.D. & C. Yellow 3 and Orange Flavor S.D. through a #20 screen
Performer:

Inventory: Step Material Action:

Verifier: Part: Target:

212.05 0
Ver.

Load the screened F.D. & C. Yellow 6, F.D. & C. Yellow 3 and Orange Flavor S.D. into the blender
Performer:

Inventory: Step Material Action:

Verifier: Part: Target:

213.00 0
Ver.

Load the second container of DiPAC (75 kg) into the blender and blend for 15 minutes
Performer:

Inventory: Step Material Action:

Verifier: Part: Target:

215.00 0
Ver.

Discharge into suitable lined containers. Record:Gross WTTare WTNet Wt.

Performer:

Inventory: Step Material Action: Inventory:

Verifier: Part: Target:

220.00 0
Verifier: Ver.

Preblend #2
Performer:

Master Production Record

MPR #:

5503

Product Code:
Chewable Vitamin C
Step Material Action:

Drug Name:
Chewable Vitamin C Tablets

Strength:
250 mg

Number:
147 1

222.00 Charge the Dipac, Orange Juice Oil, Veltol Plus, and Vanillin into a suitable P.K. blender
Performer: Part: Target:

Ver.

Inventory: Step Material Action: Inventory: Step Material Action: Inventory: Step Material Action: Inventory: Step Material Action: Inventory: Step Material Action: Inventory: Step Material Action:

Verifier: Part: Target:

223.00 0
Verifier: Part: Target: Ver.

Blend for 15 minutes

Performer:

224.00 0
Ver.

Discharge into a suitable lined container

Performer:

Verifier: Part: Target:

230.00 0
Verifier: Part: Target: Ver.

FINAL BLENDING
Performer:

231.00 0
Ver.

Weigh 327.478 kg DIPAC and charge into a suitable blender.

Performer:

Verifier: Part: Target:

232.00 0
Ver.

Add Premix #1 and Premix #2 to the contents of the blender.

Performer:

Verifier: Part: Target:

233.00 0
Ver.

Charge the blende with Candex (196.875 kg), Sodium Ascorbate (259.644 kg) andAscorbic Acid (59.231 kg)
Performer:

Inventory: Step Material Action: Inventory: Step Material Action:

Verifier: Part: Target:

234.00 0
Verifier: Part: Target: Ver.

Blend for 15 minutes

Performer:

235.00 0
Ver.

Pass 21.00 kg Stearic Acid through a #20 mesh screen and charge into the blender.
Performer:

Inventory: Step Material Action: Inventory:

Verifier: Part: Target:

236.00 0
Verifier: Ver.

Blend for 5 minutes

Performer:

Master Production Record

MPR #:

5503

Product Code:
Chewable Vitamin C
Step Material Action: Inventory: Step Material Action: Inventory: Step Material Action: Inventory: Step Material Action: Inventory: Step Material Action:

Drug Name:
Chewable Vitamin C Tablets

Strength:
250 mg

Number:
147 1

237.00 Discharge the blend into suitable containers

Performer: Part: Target:

Ver.

Verifier: Part: Target:

300.00 0
Verifier: Part: Target: Ver.

COMPRESSION
Performer:

301.00 0
Ver.

Set up rotary tablet machine using 1/2" round standard concave tooling
Performer:

Verifier: Part: Target:

301.05 0
Ver.

Compress tablets to a target hardness of 7 kp

Performer:

Verifier: Part: Target:

302.00 0
Ver.

Collect the tablets in double lined cartons with a desiccant bag between the liners.
Performer:

Inventory: Step Material Action:

Verifier: Part: Target:

303.00 0
Ver.

When compression is complete, record Gross wt., Tare wt., Net wt. of the compressed tablets.
Performer:

Inventory:

Verifier: