GMP Problems:

Dietary Supplements Health and Education Act (DSHEA) came into law in 2007 and was completely implemented in 2010. DSHEA mandates all dietary supplement manufactures be in compliance with Good Manufacturing Practices (cGMPs) located in the regulation act. Regulations include layouts, locations, and operations of the manufacturing facility. Every dietary manufacturer is required to meet the standards, even if they facilities were built prior to when the regulations were published. FDA inspectors have begun inspecting pre-established facilities and have found that half of the plants contain serious violations which have resulted to one quarter of those plants receiving warning letters. FDA inspectors have issued 483 citations and warning letters threatening producers to become compliant with the standards or risk being shut down.

Why it’s important:

Manufacturing locations and control operations must contribute to the quality of the output products. Selecting positions for equipment and other items must chose to avoid contamination risks but still permitting effective cleaning and maintenance techniques.

How to improve:

Once a facility is properly located, the design phase begins. One the important aspects of design is giving thought to the various separate areas that will be needed for each of the major functions in the facility. These areas might include:

After choosing a facility location, the next phase is designing the plant. A key aspect of design is to give thorough thought to what areas should be separated to improve facility functionality. Areas to consider include:

– Receiving/Shipping

– Weighing

– Production

– Packaging/printed material

– Storage Areas

– Ancillary areas

Receiving/Shipping: The areas for receiving and shipping products are typically near loading docks or large entrances to the plant. These areas are located on the exterior of the plant, thus opening the plant to the elements outdoors including, weather, insects, rodents, and other pests. Designs should include ways to separate the outdoor elements with the rest of the plan while unloading or shipping is occurring. Additionally, containers bring products or ingredients into the plant should be cleaned to prevent bringing unneeded dirt into the plant. A simple cloth wipe-down or quick vacuum of the containers outside of the plant should eliminate most waste located on the containers. If a separate closed-off area is not available for cleaning, an air curtain should be implemented to provide some protection to the plant.

Warehousing: InstantGMP™ MES contains software which allow employees to record incoming materials and product numbers. Employees can electronically record what is being received, how much, and necessary vendor information. Electronically recording this data can automatically update inventory modules so that all processes can be updated in real-time.

Storage Areas: Plants should have separate areas for storage of various materials and products. Storage areas should be big enough for product output levels and to ensure segregation of different types of products. Examples of products that should be separated or segregated include: raw materials, packaging materials, intermediates, bulk, final products, released, quarantined, or rejected products and materials.

Packaging/printed material: In some countries, half of all product failures occur through issues with printed materials which unfortunately result in product recalls. Ensuring the plant has security of storage areas, and issue receipts of all printed materials will alleviate many of these issues. The quality control standards for printed components must be stringent and regulated, especially if labels are required to be printed in a foreign language. Preventing mix-ups is the easiest way to reach compliance and avoid recalls.

Weighing: In order to eliminate risk of cross-contamination or mix-ups, careful attention needs to be given to the design of operation, control, recording, and cleaning systems. Environmental controls should guarantee that any powders are contained with the allowed area. To provide proper separation between weighing areas and the rest of the plant, air handling, pressure differentials, airflow patterns, or dust extraction systems need to be implemented.

Production: Special accommodations and materials should be available for employees or visitors to change clothes and footwear before entering the production areas. There should be strict storage areas for outside materials and clothing as well as pathways to assist in proper entrance or exit to the plant. Separating and segregating outside materials with materials approved for inside the plant is the best way to ensure cleanliness.

Individual air lock systems are an easy way to provide entrances to manufacturing areas as one-way pathways. Personnel should only travel in one direction changing or putting on extra clothing as an attempt to maximizes cleanliness and prevent cross-contamination.

The flow of production materials should mirror the sequence of production equipment to eliminate mix-ups or cross-contamination. Areas should be designated as work or storage areas. Logically positioning equipment will reduce risks involved with contamination, mix-ups, or skipping production steps.

Ancillary areas: Appropriate areas should be designed for proper rest and refreshment of employees. These areas should be separate from the manufacturing, packaging, storage, or quality control areas. Washing and toilet facilities should be closed off and not directly accessible from any of the plant process areas. Additionally, maintenance workshops should be segregated from any production areas. Keep proper tools in the manufacturing area placed in their proper containers.

Summary: Well thought-out manufacturing designs will include specialized areas for storage, warehousing, production, shipping, and other necessary purposes. It is key to integrate and plan for segregating non-essential areas to control contamination possibilities. The plant facility planning should be extensive and should not overlook any details which could influence product production or facility cleanliness.

You can find more articles like this 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