GMP Compliance Series: Part 9: Packaging and Labeling

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GMP Compliance Series: Part 9: Packaging and Labeling

GMP Problems:

Packaging and labeling of dietary supplements was not controlled by the FDA until 2007 when the Dietary Supplements Health and Education Act (DSHEA) became law. In 2010, the act applied to all packagers and distributors of dietary supplements who had to be in compliance with GMP requirements. Since that time, the FDA began inspecting dietary supplement companies, and 25% of these manufacturers inspected by the FDA have received Warning Letters. A warning letter is the last step before the FDA seeks an injunction to stop operation if GMP compliance issues are not adequately addressed. Packaging and labeling control of dietary supplements fall under these good manufacturing practices regulations.

Why Packaging and Labeling is important:

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 is 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 seen by the final consumer, so attention to artwork and message is necessary here. Printed packaging materials are inserted inside the secondary package. Third-level packaging is generally the cartons used to ship the product. Each of the primary, secondary, and carton packages will need their own approved labels.

How to improve the Packaging and Labeling Process:

Specifications: There are certain requirements that are specific for the 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 the product is properly identified and is consistent with your purchase order.

Labels: Labels should include the following:

  • Product name
  • Quality
  • Batch number
  • The expiry or retest date
  • Warnings, if required
  • Storage conditions
  • Names of manufacturers and suppliers

Incoming Inspection: 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.

Unique Identifier: cGMPs require 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 will need to use this unique identifier whenever you record the disposition of each unique lot within each unique shipment of packaging and labels received.


Quality Review
: Packaging and labels must be quarantined until the Quality Unit can disposition them. cGMP 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;

Storage and Release: 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.

Summary: Dietary supplement packaging and labeling controls are needed to meet the cGMP requirements under the DSHEA. Specifications are needed to make sure that the 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 a 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.

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.

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