InstantGMP Compliance Seriesfor cGMP Dietary Supplements

Equipment

Electronic cGMP Manufacturing Execution System2

Background

• Dietary Supplements are orally ingested products that contain an ingredient that is intended to supplement the diet

• Not controlled by the FDA until 2007• By 2010 any manufacturer or distributor of

dietary supplements had to be in compliance with GMP requirements

• Now 1 in 4 manufacturers inspected by FDA receive Warning Letters

Electronic cGMP Manufacturing Execution System

Equipment

• Located to ensure procedures are followed correctly

• Designed to facilitate cleaning and maintenance

• Constructed to prevent corrosion or deterioration of product

• Adapted to serve intended needs• Maintained properly at all times

Electronic cGMP Manufacturing Execution System

Equipment for Herbals

• Herbal materials can generate dust and can be susceptible to biological contamination

• Vacuum and wet-clean, dry after wet cleaning to prevent microbial growth

• Use non-wooden equipment• Only use wooden equipment when called for by

tradition, then dedicate to one product

Electronic cGMP Manufacturing Execution System

Equipment Layout and Design

• Minimize risk of cross contamination• Permit effective cleaning and maintenance

• Avoid potential for dust and dirt build-up

• Be aware of any adverse effects on the quality of products

Electronic cGMP Manufacturing Execution System

Equipment Maintenance

• Maintenance assures equipment is always ready for intended use

• Scheduled maintenance for major equipment

• Logs are needed for:

– Equipment use

– Preventative maintenance schedule

– Record of maintenance

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Equipment Log

Electronic cGMP Manufacturing Execution System

Balances and Measuring Equipment

• Must be capable of weighing or measuring the materials over the desired range

• Must be verified for their range of weights and precision.

• Must be calibrated regularly• Proper records of calibration, check weighing

and use must be maintained• Records should show what was done, by

whom, and the actual results obtained.

Example of Floor Scale Record

Electronic cGMP Manufacturing Execution System

Production Equipment

• Designed to be easily taken apart and cleaned

• Contact parts of suitable non-reactive materials so there is no hazard to the products

• Defective equipment removed, or labelled to prevent use

Electronic cGMP Manufacturing Execution System

Equipment Cleaning

• Cleaning procedures needed for each piece of equipment

• Separate cleaning procedures may be needed for different products

• SOPs should describe cleaning procedures

• Equipment should be tagged as clean or dirty

Electronic cGMP Manufacturing Execution System

• Equipment cleaning should be validated• Equipment design should promote easy

cleaning• Cleaning on scheduled basis, procedures

and records• Avoid spreading dust when cleaning with

compressed air, brooms or brushes• Washing and cleaning should be

documented in logs

Washing, cleaning and drying

Electronic cGMP Manufacturing Execution System

Making Compliance Easy

• InstantGMP has equipment logs to record all equipment procedures

• Provides convenient way to document cleaning and maintenance

• Quality can use the history when investigating deviations or diagnosing quality issues

InstantGMP™

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