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Manufacturing
Requirements
for Non-Sterile
PPEs
Dr. Muhammad Sohail(PharmD)
Member GHWP
Member APACMed
Ex-Member HDAP
Contents
1. General Part
2. Technical Part
4. Documentation
5. Trainings
3. Labelling
General Part
 Name of Manufacturing Unit
 Address of Manufacturing Unit
 Name of Production In-charge
 Name of Quality Control In-charge
 Name of CEO
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
Technical Part – Building design and
construction
 Adequate size and design
 Fire alarm system
 Fire extinguisher
 First aid kits
 Emergency exit
 Quality of ventilation
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
Technical Part – Storage area
(Raw material, In-process and Finished goods)
 As per requirement of material and product
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
Technical Part – Quality Control
Personnel
 Qualification – As determined by MDB
 Experience – As determined by MDB
Equipment
 As per PPEs intended to be manufactured
Labelling
1
 As per Chapter VI of Medical Device Rules,2017
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
Trainings
 ISO-13485
 Batch Processing
 Disposal, Storage and Handling of Wastes
 Emergency Evacuation Drill and Equipment
THANK YOU

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Manufacturing requirements for non sterile PPEs

  • 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