InstantGMP Compliance Seriesfor cGMP Dietary Supplements

Packaging and Labeling

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

Packaging Materials

• Primary packaging materials come in contact with the product

• Secondary packaging contains artwork and messages for consumer

• Printed packaging materials are inserts inside the secondary package Cartons are used to ship the packages

• Each one needs an approved, controlled label

Electronic cGMP Manufacturing Execution System

Packaging and Labeling

• Requirements specific for dietary supplements• Products received for packaging need

specifications• Must be identified and consistent with purchase

order• Packagers/labelers who return the product to the

manufacturer do not need to comply

Electronic cGMP Manufacturing Execution System

Packaging and Labeling Specs

• Specifications are needed to assure product received is consistent with your purchase order

• Specifications have to be set for any point in the packaging or labeling operation where control is needed to assure the quality of the final packaged product

• Specs are not needed for components, in-process testing or any part of the manufacturing process that is done elsewhere

Electronic cGMP Manufacturing Execution System

Label Information Includes:

– Product name– Quality– Batch number– Expiry or retest date– Warnings, if required– Storage conditions– Names of manufacturers and suppliers

Electronic cGMP Manufacturing Execution System

Incoming Inspection

• Inspect product and documentation to make sure in-coming product and labels meet specs

• Visual examination must be done at a minimum• Documentation may be an invoice, certificate,

guarantee or other supplier provided information

Electronic cGMP Manufacturing Execution System

Unique Identifier

• Identify each unique lot within each unique shipment

• Be able to trace the lot to:– The supplier– The date received– The name of packaging and label– The status of the component

• Use identifier for each disposition of a lot

Electronic cGMP Manufacturing Execution System

Quality Review

• Packaging and labels must be quarantined until the Quality Unit can release them

• Quality Unit must collect representative samples• Quality must assure correct packaging and

labels are specified in the master manufacturing record

• Quality must review any test results

Electronic cGMP Manufacturing Execution System

Storage and Release

• Store in secure conditions with authorized access

• Roll labels where possible in place of cut labels

• Loose materials stored and transported in separate, closed containers - to avoid mix-ups

• Issued by designated personnel• SOP for issue and returns

Electronic cGMP Manufacturing Execution System

Summary

• Packaging and labeling controls are needed to meet the cGMP requirements

• Specifications make sure that product is properly identified and is consistent with your purchase order

• Labels need specific information• Incoming inspections mut be done on each product• A unique identifier lets you trace each lot• Packaging and labels are in quarantine until disposition• Keep printed packaging materials, labels and cartons

organized and stored properly to prevent mix-ups.

Electronic cGMP Manufacturing Execution System

InstantGMP™ MES

• Electronic cGMP Manufacturing Execution System• Specifically designed for manufacturing GMP regulated

products• Modules for specifications, inventory control and

electronic batch records for packaging and labeling operations

• Quality requirements and cGMP compliance are built into the software

• Meeting FDA regulations is easy

InstantGMP™

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