InstantGMP Compliance Series - Facility Areas
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Transcript of InstantGMP Compliance Series - Facility Areas
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InstantGMP Compliance Seriesfor cGMP Dietary Supplements
Facility Areas
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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
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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
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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
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Electronic cGMP Manufacturing Execution System5
Receiving
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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
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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)
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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
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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
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Weighing Records
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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
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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
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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
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InstantGMP Room Log
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Room Log
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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
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InstantGMP™
Find more videos on cGMP Compliance for Dietary
Supplements in the Resource Center at
www.instantgmp.com