instantgmp cmpliance series - packaging and labeling
DESCRIPTION
Keeping in GMP compliance during packaging and labeling operations means meeting special requirements. This presentation describes these requirements.TRANSCRIPT
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InstantGMP Compliance Seriesfor cGMP Dietary Supplements
Packaging and Labeling
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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.
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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
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InstantGMP™
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