Information Required
Uploaded by
VIJAY SINGHInformation Required
Uploaded by
VIJAY SINGH1.
NAME OF THE COMPANY :
2. WEBSITE :
3. REGD OFFICE ADDRESS :
4. Mob. No. :
5. Email. :
6. OF ESTABLISHMENT :
7. YEAR OF COMMENCEMENT OF PRODUCTION:
8. TYPE OF BUSINESS :
9. Site Address:
10. Plot Area: ……………………….total Covered Area:
11. Pic of plant front, Lab & Production Area
12. LIST OF MEDICAL DEVICES MANUFACTURING:
13. The area of production is as follows:
S.No. Location Description Area Sq Ft
1 Raw Material Storage Area
2 (De dusting , Quarantine)
3 Finished Goods Storage Area
4 Change room -1(Gents)
5 Change room -1(Ladies)
6 Assembly Area
7 QC lab
8 Microbiology Lab
11 Secondary packaging Area
12 Admin Area
15 Total constructed Area
16 Total Area
14. NUMBER OF EMPLOYEES (ENGAGED IN PRODUCTION, QUALITY, WEAR HOUSE AND DISTRIBUTION
Sr. no. Department Manpower
01 Production
02 Quality Assurance
03 Quality control
04 Washing
05 Storage & Distribution
06 Purchase
07 Production development
08 H.R
09 Accounts
Total
15. QUALIFICATION, EXPERIENCE & RESPONSIBLITIES OF KEY PERSONNEL
Sr. Name Qualification Experience Remark
Production In-charge /manufacturing chemist
1
QC/QA Manager/ analytical chemist
1
Testing Incharge
1
LIST OF MACHINES FOR STERILE NON-STERILE MEDICAL DEVICES
SR.NO NAME OF MACHINE LOCATIONS QTY. REMARKS
1
2
3
4
5
6
7
8
9
10
List of Measuring & Test Equipment
S. No. Name of equipment Location Quantity Remark
1.
2.
3.
4.
5.
6.
7.
8.
9.
