The equipment used in GMP production of dietary supplements must comply with the FDA requirements as outlined in their DSHEA Act. This article summarizes these requirements.

Putting it in a nutshell, the FDA (the U.S. Food and Drug Administration) basically requires that all the equipment you use for dietary supplement manufacturing must be capable of doing what they are supposed to do (in this situation, the equipment for dietary supplement manufacturing must function properly). This requirement refers to both old and new equipment. Otherwise stated, the old equipment that manufacturers used before these CGMPs (Current Good Manufacturing Practices) must function as good as the new equipment. If the criteria are not met, the manufacturer can face the risk of getting a significant penalty.

Possible Limitations Of Old Equipment

It must be mentioned that some of the old systems may not function well enough to be considered validatable or they may work only within a very small range of environmental conditions, such as humidity or temperature. Moreover, some of them might be a lot more sensitive to electromagnetic interference, which may cause them to malfunction. Regarding both the design and the development of these systems, the current terms of use must be taken into account as soon as possible. This is highly important when it comes to prevents any potential problems that can affect not only the productivity of the company, but also the quality of the dietary supplements.

The limitations mentioned above must be taken into consideration whenever installing these systems. Moreover, the equipment must be tested according to IQ/OQ (installation qualification/operational qualification) and see whether the systems are eligible to use. In addition, proper maintenance is also essential and a team of well-trained specialists must perform it regularly. These two aspects can significantly prolong the lifetime of these systems and increase the quality of the final product. Nevertheless, maintenance and quality control must be performed by authorized personnel only. The quality control team must thoroughly inspect calibrations on a regular basis, in order to make sure that the equipment for GMP dietary supplement manufacturing works as it is supposed to.

The Importance Of Periodic Controls

A periodic inspection can reveal one or more problems regarding the equipment, problems which can interfere with the quality of the dietary supplements if they are not addressed. These problems are not easy to identify, this is why regular inspection of the equipment is absolutely necessary. The control team can identify and address any equipment-related problem in a time-effective manner. If these problems are identified in a timely manner, the technicians can efficiently solve them and prevent them from affecting the overall quality of the products. This regular inspection is fully compliant with Sec. 111.37(b)(8), which states that the quality control team must thoroughly review all the records for equipment calibration before approving them. This is one of the most important regulations set by the United States Food and Drug Administration.

At the moment of speaking, formal process validation is not required for the equipment. The final Sec. 111.30(e) only states that you must check the equipment in order to make sure that it works according to the intended use. Moreover, it also states that a correct quality control operation for instruments and equipment must include: checking and approving all the processes needed for controls and instruments; Reviewing instrument calibration records on a constant basis and periodically checking mechanical, automated or electronic equipment. All these actions aim to monitor the equipment and ensure that it functions according to its intended use.

The final Sec. 111.117(a), (b), and (c) mentions that the quality control team must carefully review the records for gauges, apparatus as well as recording devices, check and approve the processes needed for instrument calibration and, last but not least, check all the available records for equipment calibrations and inspections.

To sum up, these are the Good Manufacturing Practices (GMPs) that apply to dietary supplement manufacturing. They aim to prevent equipment from interfering with the quality of the dietary supplements, because this can pose serious health threats to those who consume them. Nevertheless, these new regulations can be considered a win-win situation, due to the fact that if manufacturers constantly check their equipment, they can find any problems that may cause the equipment to malfunction. By identifying and solving the problems in real-time, the manufacturer can save a lot of money that he would otherwise spend if the problem extended to other components.

An equipment log is the ideal solution to keeping track of equipment, how it was used and when it was cleaned or maintained. InstantGMP provides an equipment log as part of its manufacturing execution system for GMP manufacturing. It allows operators to record preventative maintenance dates and when calibrations will be due. They can access this log during manufacturing so they can update the use of each piece of equipment in real time for each batch where that equipment is used.

Find more articles like this one 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: Medical Business
Keywords: GMP Compliance, Dietary Supplements, Manufacturing Execution Software, Electronic Batch Record