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TitleProcess Validation of Liquid
File Size139.2 KB
Total Pages24
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Page 12

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Protocol No.: Process Validation Protocol for Oral liquid/Suspension

Quality Assurance Department Page 12 of 24

Title : Validation Protocol for B. No. :



Prepared By Checked By Approved By









5.0 Sampling, Test Parameters, Acceptance criteria



5.1 Sampling locations:



































Sampling site: - Top (A), Middle (B), Bottom(C) position; use the sample tube for A&B

and bottom valve for Position C

Sampling Qty.: -About 100 ml from each sample site

Sampling Time: - While mixing is on: - After ____ minutes, after ____ minutes, After _____ minutes

__________ minutes A,B & C ____________minutes A,B & C ________ minutes A,B & C

Total samples:________

1. TOP –SAMPLE A

2. MIDDLE –SAMPLE B

3. BOTTAM –SAMPLE C

BOTTOM VALVE

Page 13

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Protocol No.: Process Validation Protocol for Oral liquid/Suspension

Quality Assurance Department Page 13 of 24

Title : Validation Protocol for B. No. :



Prepared By Checked By Approved By







5.2 Sampling:



Stage / Test Parameter Equipment

(Size, Location & Time)

Acceptance Criteria

Sugar syrup Preparation Determination on each sample, for

temperature, & Clarity

Not more than ______

minutes

Manufacturing

Appearance

pH

weight per ml

Identification



Assay



Sampling thief

� As specified in the BMR

� Ref. std. :

� As specified in the BMR

� As per standard testing

procedure

� Assay 90 % to 110 %



Bottle washing Visual inspection inspected for particulate

matter

Filling & sealing

Volume

Appearance

Odour

Colour



Measuring cylinder

Visual inspection,

Visual inspection

Visual inspection



Not less than label claim.

As specified in the BMR.

As specified in the BMR

As specified in the BMR

Capping Leak test

Cap breaking and recapping

Complies leak test

Labeling & Packing Clean, Position & Proper Sealing Clean label and proper sealing

Page 23

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Protocol No.: Process Validation Protocol for Oral liquid/Suspension

Quality Assurance Department Page 23 of 24

Title : Validation Protocol for B. No. :



Prepared By Checked By Approved By







Data recording sheet VIII



Sr

No

Name of critical equipment / Utilities Qualification /

Validation file

reference No

Date of Qualification /

Validation

1 S.S. Manufacturing tank

2 S.S. Storage vessel

3 Filter press

4 Transfer Pump

5 Washing Machine

6 Filling Machine

7 Sealing Machine

8 Labeling Machine



Utilities:

1 AHU System

2 Water System

3 Compressed Air

4 Steam

5 Lightning

6 Drain

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