Service Description:
– Design Qualification – Facility Master Program (Program and
Form – Checklist)
– Includes requirements per Title 21 Food and Drugs, Chapter I, FDA
Department of Health and Human Services, Subchapter B –
Food for Human Consumption, Part 117 CGMP HARPC for Human
Food, Part 111 CGMP in Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary Supplements, and Part 507 CGMP
HARPC for Food for Animals
– Includes requirements for: Site Location and Construction,
Construction of Premises and Equipment, Floors, Drains and
Waste Traps, Walls, Partitions, Doors and Ceilings, Stairs,
Catwalks and Platforms, Lightings and Light Fittings,
Inspection/Quality Control Area, Dust, Insect and Vermin
Proofing, Ventilation, Equipment, Utensils and Protective
Clothing, Cleaning and Sanitation, Hand Washing, Staff
Amenities, Change Rooms, Laundry, Sanitary Facilities,
Lunchrooms, Water Supply, Water Treatment, Quality of Air and
Other Gases, Storage and Handling of Goods, Storage of
Hazardous Chemicals and Toxic Substances, Process Flow, and
Grounds and Roadways.
Requirements:
– Send approved company logo and your facility address to be
incorporated on the documents, if applicable, to
info@consultareinc.com.
– Google Meet – Screen Share for discussion. To be scheduled by our
FSQA Compliance Team, if applicable.
Deliverables:
– Design Qualification – Facility Master Program
– Design Qualification – Facility Master Checklist
Delivery Date:
-2 to 3 Business Days upon receipt of completed information
required for inputs.
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