GMP Problems

The FDA did not regulate packaging or labeling of dietary supplements until 2007, when the Dietary Supplements Health and Education Act (DSHEA) came into law. Then in 2010, the Act was applied to all packagers and distributors of dietary supplements, meaning they too had to come under GMP compliance. Since FDA inspectors began investigating dietary supplement companies in 2010, one quarter of inspected manufacturers have received FDA Warning Letters. A warning letter is the final step before FDA pursues an injunction to halt operations if compliance issues are not resolved. Packaging and labeling regulation of dietary supplements fall underneath all these GMP regulations.

Why it’s important:

Packaging materials and printed packaging supplies require special attention to care. The manufactured products come into direct contact with packaging materials so it is vital the packaging materials like bottles, ampoules, or foil in blister and strip packing are chosen for their safety in not allowing interactions between the products and packaging. Outermost packaging, seen by the consumer, should have necessary messages or artworks. This outermost or secondary packaging should contain printed insert materials. Third level packaging is the cartons which are used to ship large batches of the product. Each level of packaging needs their own specially approved labels.

How to improve

Specifications: Specific packaging and labeling must meet certain requirements. One requirement is to institute specifications for processing incoming dietary supplement packaging to ensure products are correctly identified and consistent with the purchase order.

Labels: Labels should include the following:

– Quality

– Product name

– Batch number

– Warnings, if required

– Storage conditions

– Expiry or retest date

– Names of manufacturers and suppliers

Incoming Inspection: An incoming product must first be visually examined and proper documentation should show specifications have been met prior to packaging or labeling the product. Review the supplier’s invoice, guarantee, or certification as well as visually inspect the containers, enclosures, and labels to ensure that product has met specifications. Documentation from the supplier should consist of invoices, certifications, or guarantees proving the product is what was ordered.

Unique Identifier: cGMPs require that batches or shipments are tracked from the supplier with information about the packaging, labels, specific dates, current status of packaging, and the dietary supplement within the packaging. A distinguished unique identifier for each batch or shipment should be used to record the disposition of shipments packaging or labels that are received.

Quality Review: Incoming packaging and labels are required to be quarantined until quality units can review them. cGMP mandates quality control units collect samples of each batch of packaging and labeled dietary ingredients or supplements in order to determine if the correct packaging and labeling materials match what is specified in the master manufacturing record. Quality control personnel also need to evaluate and approve results of tests or examinations that were conducted on the packaging and labels.

Storage and Release: It is very important to prevent mix-ups of printed packaging materials such as labels, leaflets, or cartons. Access to printed packaging should be regulated to prevent unauthorized access or tampering. Already cut labels or any other loose printed packaging components should be stored and transported in closed, separate containers to prevent mix-ups. Additionally, only quality control personnel should be able to issue the printed packaging materials to production based on established SOPs.

Summary: In order to meet cGMP requirements established from DSHEA, specifications and controls are needed on dietary supplement packing and labeling. Specifications ensure products are properly identified and consistent with purchase orders. Labels should include easily apparent product identities, dates of manufacturing, and batch numbers. Inspections must be conducted on all incoming products. Quality control units must quarantine each incoming shipments which must have specific traceable identifiers. Organization of packaging materials, cartons, and labels in important to prevent mix-ups.

You can find more articles like these by searching for \”InstantGMP Compliance Series\”.

Rick Soltero, President of InstantGMP designed an electronic manufacturing execution system that is cloud based and Part 11 compliant. He also developed InstantGMP-Lite, an electronic batch record system for cGMP manufacturing. These make staying in GMP compliance easy.

Rick Soltero, President of http://www.InstantGMP.com, designed this electronic manufacturing execution system that is cloud based and Part 11 compliant. He also developed http://www.InstantGMP-Lite.com, an electronic batch record system for cGMP manufacturing. These make staying in compliance easy.

Author Bio: Rick Soltero, President of InstantGMP designed an electronic manufacturing execution system that is cloud based and Part 11 compliant. He also developed InstantGMP-Lite, an electronic batch record system for cGMP manufacturing. These make staying in GMP compliance easy.

Category: Wellness, Fitness and Diet
Keywords: GMP Compliance, Dietary Supplements, Manufacturing Execution Software, Electronic Batch Record