instantgmp compliance series - facility areas
DESCRIPTION
This presentation describes the various GMP areas in a production facility.TRANSCRIPT
InstantGMP Compliance Seriesfor cGMP Dietary Supplements
Facility Areas
Electronic cGMP Manufacturing Execution System
Basic Principles of GMP Areas
• Separated areas for separate functions– Receiving/Shipping– Storage– Packaging/printed material– Weighing– Production– Ancillary areas
Electronic cGMP Manufacturing Execution System
Receiving/Shipping
• Typically housed in same area near loading dock
• Often has large garage style door to outside• Should be kept separated from production and
storage areas• Needs extra attention to prevent inspects and
pests from entering building
Electronic cGMP Manufacturing Execution System
Incoming Containers
• Clean incoming container using a vacuum cleaner
• Clean with a cloth or duster to finish
• Use air curtains and air tunnels if there are no segregated areas available
Electronic cGMP Manufacturing Execution System5
Receiving
Electronic cGMP Manufacturing Execution System
Warehousing
• Separate storage areas of sufficient capacity and control
• Orderly storage of categories of materials and products
• Separate and segregated areas: starting materials, packaging materials, intermediates, bulk, finished products, quarantined, released, rejected, returned and recalled products and materials
Electronic cGMP Manufacturing Execution System
Storage Areas
• Quarantine area: clearly marked and access restricted
• A separate sampling area is the norm: no risk for contamination or cross-contamination
• Segregated areas for rejected, recalled and returned materials and products
• Safe and secure areas for highly active, radioactive materials, narcotics and other materials (risk of abuse, fire, explosion)
Electronic cGMP Manufacturing Execution System
Packaging/Printed Material
• Critical to ensure compliance with correct labelling of products
• Special attention to sampling• Special attention to safe and secure storage• Ensure compliance with specifications, prevent
mix-ups
Electronic cGMP Manufacturing Execution System
Weighing
• Weighing operations – in separated areas• Appropriate design (see also training material on
HVAC)• Provision for dust control• Smooth, impervious, durable, easy-to-clean
finishes• Cleaning procedures and records• Documentation, e.g. SOPs, logs and records
Weighing Records
Electronic cGMP Manufacturing Execution System
Entrance to Production
• Separate area needed to change and store clothes
• Step through in changing room keeps production area separated and clean
• Keeps outside dust and dirt from entering production area
Electronic cGMP Manufacturing Execution System
Production Area
• Layout in sequence of production to avoid mix-ups and cross-contamination
• Appropriate cleanliness level• Adequate work and in-process storage space• Orderly and logical positioning of equipment• minimizes risk of contamination, mix-ups and
missing production steps• Specially designed areas for packaging
Electronic cGMP Manufacturing Execution System
Environmental Controls
• Effective ventilation with air control facilities• Including filtration of air to a sufficient level to
prevent contamination and cross-contamination – also external environment
• Control of temperature and relative humidity where necessary
• Regular monitoring of conditions during production and non-production periods
InstantGMP Room Log
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Room Log
Electronic cGMP Manufacturing Execution System
Ancillary Areas
• Rest and refreshment rooms separate from manufacturing and quality control areas
• Changing, washing and toilet areas accessible and appropriate numbers
• Maintenance workshops separated from production - if not possible – tools in reserved areas
• Animal houses well isolated – separate air handling and entrance
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Small ScaleGMP Manufacturing Facility
Material flow
InstantGMP™
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