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