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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Supplements in the Resource Center at

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