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Autoclave Design Qualification Report

1) The document is a design qualification report for an autoclave at D.Y. Patil College of Pharmacy in Pune. 2) It outlines the objectives, scope, responsibilities, user requirements specifications, factory acceptance test procedure, and approval for the autoclave. 3) The autoclave will be used to sterilize media, glassware, and products, and the design qualification is to ensure it was manufactured as per specifications and complies with the scope of supply.

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Navdeep Chaudhary
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583 views3 pages

Autoclave Design Qualification Report

1) The document is a design qualification report for an autoclave at D.Y. Patil College of Pharmacy in Pune. 2) It outlines the objectives, scope, responsibilities, user requirements specifications, factory acceptance test procedure, and approval for the autoclave. 3) The autoclave will be used to sterilize media, glassware, and products, and the design qualification is to ensure it was manufactured as per specifications and complies with the scope of supply.

Uploaded by

Navdeep Chaudhary
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd

[Link].

COLLEGE OF PHARMACY, PUNE


DESIGN QUALIFICATION REPORT
Instrument: Autoclave (Instrument No. )
REPORT NO. DYP/QAT/PV/DQ/RP001/2016-17 EFFECTIVE DATE
[Link]
DYP/QAT/PV/DQ/PC001/2016-17 PAGE NO. 1of 9
NO.

INSTRUMENT DETAILS
Name of Equipment Autoclave
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 Objective:
To perform design qualification of Autoclave 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 Autoclave
The equipment shall be used for Sterilization of Media, glasswares, product etc.

3.0 Responsibility:
Roll No.
Name:
Class and department:

Prepared By Checked By Approved BY


Name &
Designation

Sign & Date


[Link]. COLLEGE OF PHARMACY, PUNE
DESIGN QUALIFICATION REPORT
Instrument: Autoclave (Instrument No. )
REPORT NO. DYP/QAT/PV/DQ/RP001/2016-17 EFFECTIVE DATE
[Link]
DYP/QAT/PV/DQ/PC001/2016-17 PAGE NO. 2of 9
NO.

4.0 USER REQUIREMENT SPECIFICATIONS:

DESCRIPTION SPECIFICATION OBSERVATIONS

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 all 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

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

Prepared By Checked By Approved BY


Name &
Designation

Sign & Date


[Link]. COLLEGE OF PHARMACY, PUNE
DESIGN QUALIFICATION REPORT
Instrument: Autoclave (Instrument No. )
REPORT NO. DYP/QAT/PV/DQ/RP001/2016-17 EFFECTIVE DATE
[Link]
DYP/QAT/PV/DQ/PC001/2016-17 PAGE NO. 3of 9
NO.

Customer:

Student name Roll No. Signature Date

7.0 Reference documents


1. Manufacturer brochure:
2. DQ Protocol No.:

Written By Signature Date

Checked By Signature Date

Approved By Signature Date

Prepared By Checked By Approved BY


Name &
Designation

Sign & Date

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