Downloaded 71 times
Uploaded byInstantGMP™
InstantGMP Cmpliance Series - Packaging and Labeling
The document outlines compliance requirements for packaging and labeling of dietary supplements under cGMP (current Good Manufacturing Practices). It emphasizes the necessity of specifications, quality inspections, and unique identifiers to ensure product integrity, alongside the need for organized storage and handling. The InstantGMP MES is introduced as a software solution designed to facilitate adherence to these cGMP regulations.
More Related Content
Similar to InstantGMP Cmpliance Series - Packaging and Labeling
InstantGMP Cmpliance Series - Packaging and Labeling
- 1. InstantGMP Compliance Series forcGMP Dietary Supplements Packaging and Labeling
- 2. Background • Dietary Supplementsare 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 2
- 3. 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
- 4. 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
- 5. Packaging and LabelingSpecs • 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
- 6. 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
- 7. Incoming Inspection • Inspectproduct 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
- 8. Unique Identifier • Identifyeach 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
- 9. Quality Review • Packagingand 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
- 10. 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
- 11. Summary • Packaging andlabeling 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
- 12. InstantGMP™ MES • ElectroniccGMP 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 Electronic cGMP Manufacturing Execution System
- 13. InstantGMP™ Find morevideos on GMP Manufacturing in the Resource Center at www.instantgmp.com
Editor's Notes
- #2 The staff at InstantGMP prepared the GMP for Dietary Supplements Compliance Series of presentations to focus on good manufacturing practices and GMP compliance for dietary supplements manufacturing. These are brought to you by our quality and manufacturing experts in the hope that it will help you avoid any GMP compliance issues in your shop. This presentation will address procedures for packaging and labeling.
- #3 Dietary Supplements are orally ingested products that contain an ingredient that is intended to supplement the diet. Manufacturing of dietary supplements was not controlled by the FDA until 2007. At that time the Dietary Supplements Health and Education Act became law. It required all manufacturers or distributors of dietary supplements to be in compliance with GMP requirements by 2010. Since then 1 in 4 dietary supplement manufacturers inspected by the FDA have received Warning Letters threatening to stop their operation if compliance issues are not addressed. This series was started to provide education and guidance for dietary supplement manufactures who want to improve their good manufacturing practices compliance. Packaging and labeling control fall under good manufacturing practices.
- #4 Packaging materials and printed packaging materials need their own special care. The product will come into direct contact with the primary packaging materials so it important that these materials such as ampoules, bottles and foil used in blister or strip packing, are picked for their ability to contain the product without allowing an interaction with the product. Secondary packaging is generally the outside packaging that is seen my the final consumer so attention to artwork and message is necessary here. Printed packaging materials are inserts inside the secondary package The third level packaging is generally the cartons that are used to ship the product. Each of the primary, secondary and carton packages will need their own approved labels.
- #5 There are certain requirements that are specific for packaging and labeling of dietary supplements. The first requirement is to establish specifications for a product you receive for packaging or labeling as a dietary supplement to make sure that product is properly identified and is consistent with your purchase order. If you are a packager or labeler who packages and labels for the manufacturer and you return the packaged and labeled product to the manufacturer, you would not have to comply with this rule.
- #6 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
- #7 Labels should include the following: Product name Quality Batch number Expiry or retest date Warnings, if required Storage conditions Names of manufacturers and suppliers
- #8 Before you package or label an incoming product, you must visually examine the product and have documentation to make sure your specifications are met. At a minimum, you must conduct a visual identification of the containers, closures and labels and review the supplier's invoice, guarantee, or certification to determine whether your specifications are met. Your documentation may consist of an invoice, certificate, guarantee, or other documentation from the supplier to ensure that the product is adequately identified and is the product that you ordered.
- #9 GMPs requires you to identify each unique lot within each unique shipment of packaging and labels in a way that allows you to trace the lot to the supplier, the date received, the name of the packaging and label, the status of the packaging and label and to the dietary supplement you distributed. You need to use this unique identifier whenever you record the disposition of each unique lot within each unique shipment of packaging and labels. each shipment lot received.
- #10 Packaging and labels must be quarantined until the Quality Unit can release them GMP regulations require the quality control unit to collect representative samples of each batch of packaged and labeled dietary ingredients or dietary supplements to determine whether you used the packaging specified in the master manufacturing record and applied the label specified in the master manufacturing record. Quality personnel need to review and approve the results of any tests or examinations conducted on the packaging and labels;
- #11 Preventing of mix-ups of printed packaging materials such as leaflets, labels and cartons is very important. The access to printed packaging material should be controlled to prevent any unauthorized access. Cut labels and other loose printed packaging materials should be stored and transported in separate, closed containers to prevent possible mix-ups. Only quality personnel should issue printed packaging materials to production according to written SOPs.
- #12 Dietary supplement packaging and labeling controls are needed to meet the cGMP requirements under the DSHEA. Specifications are needed to make sure that product is properly identified and is consistent with your purchase order. Labels need specific information so that information such as product, date of manufacturer and batch number are readily apparent. Incoming inspections such as visual examination must be done on each product. There must be an unique identifier so you can trace each lot, The Quality Unit must quarantine each lot of packaging and labels until they can disposition them. It is important to keep printed packaging materials, labels and cartons organized and stored properly to prevent any mix-ups.
- #13 InstantGMP™ MES is an electronic manufacturing execution system that was specifically designed for manufacturing dietary supplements and other GMP regulated products. It has modules for specifications, inventory control and electronic batch records for packaging and labeling operations. Quality requirements and cGMP compliance are built into the software so meeting FDA regulations is easy.