GMP Problems:

Since 2007, dietary supplement manufacturers have to be within GMP regulations under the Dietary Supplement Health and Education Act. The Act spells out regulations relating to manufacturing facility designs, locations, and operational processes. “Grandfathered in” manufacturer facilities are not exempt from compliance within the Act, and thus must adjust their facilities to become compliant.

Why it’s important:

When designing and laying out a facility, there are several things to consider. First, the land and buildings should aid in the manufacturing process and contribute towards quality products. Construction designs must mitigate risks of contamination by properly allowing regular cleaning maintenance to avoid the build-up of dirt and dust. FDA inspectors have issued 483 citations and warning letters for faulty facility designs that contributed to contaminated products. These citations and warning letters could lead to halt operations until the FDA has proof the issues are fixed and the plant is within compliance.

How to improve

Location: The geography area of a plant could have a big impact on facility designs. Special attention should be given to locations with environmental hazards such as flooding, which could impact shipping routes or stop manufacturing operations.

Additionally, surrounding areas next to the plant are also important. Companies located in urban areas will have to take in design precautions which may be different if located in rural settings. If surrounding environments change, measures may need to be taken to adjust cleaning procedures or other processes.

Layout: Plant designs and arrangements should contribute towards quality products. Layouts should avoid contamination risks and allow for effective cleaning and maintenance to minimize dirt and dust build-up.

Facility Flow: The sequence of events and processes should be considered when design the process flow. Equipment layouts should minimize cross-contamination or possible mix-ups. Dirty milling or crushing operations, for example, should be segregated from packaging and contamination with finished products. Materials flow is the process of routing materials through the facility. During this process, material status should be monitored to show if the products are approved, rejected, or quarantined to eliminate cross-flow of materials.

People flow: In addition to product flow, a plan should layout routes for personnel movements. Where employees should enter, movements and paths within the facility, and where they should exit, all should be considered and planned. Limiting movement areas will cut down on contamination possibilities and will limit non-essential personnel movements in critical passages.

Building Materials: Proper building construction materials should be used in order to limit cracks, withstand environmental pressures or vibrations, and allow for easy cleaning procedures. Electrical power supply should be sufficient to maintain consistent performance of instruments and equipment. If constant electrical power supply is not available, the use of power generators will have to be considered. There should also be built in controls to adjust temperature or relative humidity to aid in production processes. Commonly, different materials or products are required to be processed or stored at varying conditions. Temperatures and RH should be monitored and controlled through established SOPs, then consequently documented for record keeping. Additionally, ventilation should keep the air clean and sanitary while products are being produced. Proper ventilation could have drastic effects on manufacturing or storage procedures. Flat surfaces such as walls, floors, or ceilings should be easy to clean and suitable for conditions. Ledges should be avoided as they commonly collect dirt and dust. Overall designs should limit dirt and dust build-up which could contaminate products.

Ventilation and Airlocks: As stated earlier, ventilation is vital in eliminating cross-contamination possibilities. Incoming air should be filtered appropriately to standard to achieve cleanliness to the room standard. Pressure gauges must also be present in areas where air extraction or air-locks are used to maintain control. Recirculated air is often overlooked. For example, if a ventilation system provides 100% fresh air, then other rooms can be used for different products at the same time. Conversely, if a system recirculates air, all rooms must have filters in order to process products at the same time. If filters are not installed, cleaning processes will have to include cleaning all ductwork.

Information about different rooms within a facility can be maintain through a software log on InstantGMP™ MES. Room logs should track any activities conducted in the room, and records of batch numbers produced in that room. Room log records can also include cleaning processes, cleaning agents used, number of products produced, temperature and humidity readings, or any other deviating observations. This log history is important to quality control personnel who will use the log to investigate quality issues involving products produced in a particular room.

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