Manufacturing requirements for manufacturing of non sterile PPEs as per Medical Device Rules 2017 of Pakistan

1. Manufacturing
Requirements
for Non-Sterile
PPEs
Dr. Muhammad Sohail(PharmD)
Member GHWP
Member APACMed
Ex-Member HDAP

2. Contents
1. General Part
2. Technical Part
4. Documentation
5. Trainings
3. Labelling

3. General Part
 Name of Manufacturing Unit
 Address of Manufacturing Unit
 Name of Production In-charge
 Name of Quality Control In-charge
 Name of CEO

4. Technical Part – Location and
Surroundings
I. Area
 It shall be appropriate
II. Location
 Site verification
 Fee of Rs.5,000/= with land and ownership document
 Industrial area location (no site verification inspection required)
 It shall not be in residential or commercial area
 Site verification inspection is required for unclassified area

5. Technical Part – Building design and
construction
 Adequate size and design
 Fire alarm system
 Fire extinguisher
 First aid kits
 Emergency exit
 Quality of ventilation

6. Technical Part – Services
 Electrical Supply
 Lighting
 Pest Control
 Temperature & Humidity Control
 HVAC not mandatory however,
hygienic environment and cleanliness
required
 Waste management for wastewater
treatment and hazardous waste

7. Technical Part – Storage area
(Raw material, In-process and Finished goods)
 As per requirement of material and product

8. Technical Part – Production
 ISO - 13485
 ISO - 14971
Standards
Personnel
 Qualification – As determined by MDB
 Experience – As determined by MDB
Equipment
 Equipment and lines must be identified
Health & Safety
 Electrical cables and switches should be
properly covered

9. Technical Part – Quality Control
Personnel
 Qualification – As determined by MDB
 Experience – As determined by MDB
Equipment
 As per PPEs intended to be manufactured

10. Labelling
1
 As per Chapter VI of Medical Device Rules,2017

11. Documentation
 SOPs from procurement till dispatch
 SOPs for emergency exit and alarms
 Evacuation plan
 Employees medical record
 Written responsibilities for all personnel with training record

12. Trainings
 ISO-13485
 Batch Processing
 Disposal, Storage and Handling of Wastes
 Emergency Evacuation Drill and Equipment

13. THANK YOU