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Tablet Compression Machine Qualification

The document details the design qualification of a tablet compression machine. It outlines the objectives, scope, responsibilities, user requirements, FAT procedure, design approval, and reference documents for qualifying the machine's design.

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gayatri maldhure
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508 views4 pages

Tablet Compression Machine Qualification

The document details the design qualification of a tablet compression machine. It outlines the objectives, scope, responsibilities, user requirements, FAT procedure, design approval, and reference documents for qualifying the machine's design.

Uploaded by

gayatri maldhure
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
  • Scope
  • Objectives
  • User Requirement Specifications
  • FAT Procedure
  • Reference Documents
  • Design Qualification Approval

DESIGN QUALIFICATON REPORT

Instrument : Tablet Compression Machine


REPORT NO. EFFECTIVE DATE
REF. PROTOCOL NO. PAGE NO

INSTRUMENT DETAILS

Name of Equipment Tablet Compression Machine


Location of the Equipment
Equipment Identification No.
Model No
Make
Date of Purchase

TABLE OF CONTENTS

1.0 Objective
2.0 Scope
3.0 Responsibility
4.0 User requirement specification
5.0 FAT Procedure
6.0 Design qualification approval
7.0 Reference documents

1.0 Objectives:
To perform design qualification of Tablet Compression Machine and assure
that the machine is manufactured as per the URS and it complies with the
scope of supply.

2.0 Scope
The scope of this qualification document is limited to the design qualification of Tablet
Compression Machine . The equipment shall be used for compression of drug to form
it’s tablet dosage form.

Prepared By Checked By Approved By


Name &
Designation
Sign & Date
DESIGN QUALIFICATON REPORT
Instrument : Tablet Compression Machine
REPORT NO. EFFECTIVE DATE
REF. PROTOCOL NO. PAGE NO

3.0 Responsibility

4.0 USER REQUIREMENT SPECIFICATIONS:

DESCRIPTION SPECIFICATION OBSERVATION

5.0 FAT Procedure


After the completion of the erection work of the machine, client shall be informed to
perform the FAT
Client shall perform the FAT at the manufacturer site and record the data in the
prescribed FAT document as per details given below
1. Test criteria
2. Design verification check list
3. Deficiency and corrective action report
4. Pre installation requirement
5. Final report

Prepared By Checked By Approved By


Name &
Designation
Sign & Date
DESIGN QUALIFICATON REPORT
Instrument : Tablet Compression Machine
REPORT NO. EFFECTIVE DATE
REF. PROTOCOL NO. PAGE NO

6.0 Design qualification approval :


According to the data collected as a result of this study, the equipment has been properly
designed & qualified in accordance with standards and is now available for process
qualification.

Suppliers Name Position Signature Date

7.0 Reference documents :


1. Manufacturing brochure
2. DQ Protocol No.:

Written By Checked By Approved By


Signature
Date

Prepared By Checked By Approved By


Name &
Designation
Sign & Date
DESIGN QUALIFICATON REPORT
Instrument : Tablet Compression Machine
REPORT NO. EFFECTIVE DATE
REF. PROTOCOL NO. PAGE NO

Prepared By Checked By Approved By


Name &
Designation
Sign & Date

DESIGN QUALIFICATON REPORT Instrument : Tablet Compression Machine REPORT NO.
DESIGN QUALIFICATON REPORT Instrument : Tablet Compression Machine REPORT NO.
DESIGN QUALIFICATON REPORT Instrument : Tablet Compression Machine REPORT NO.
DESIGN QUALIFICATON REPORT Instrument : Tablet Compression Machine REPORT NO.

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