GMP Problems:

Dietary Supplements must be manufactured within cGMP regulations which are listed in the Dietary Supplements Health and Education Act that became law in 2007. The FDA has inspected many dietary supplement manufactures and distributors which have resulted in half of the companies receiving citations for failure to be within GMP requirements in 2010. Half of the companies that were cited also received Warning Letters from the FDA threating to halt all processes until compliance issues were resolved. A commonly cited issue was manufacturers failing to keep their production equipment within regulations and under compliance.

Why it’s important:

Equipment used in production must be located, maintained, and operated properly to avoid cross-contamination or mix-up possibilities. The FDA will consider supplements adulterated if equipment is not within compliance, and the Agency will expect “contaminated” supplements be rejected. If these products make it to market, the FDA could mandate recalls which would have undesirable effects on a company’s economic health and reputation.

How to improve

Equipment Design:

Proper design of equipment will assist in simple cleaning and maintenance procedures as well as prevent operations errors. Proper design could allow batch numbers to be changed and adjusted within machines, for example, if a labeling machine has a block which was required to be removed prior to setting up a new batch, physical checks and changes are required. However, new products and devices are available that can streamline this process and permits batch number changes through simple keyboard commands. Through this new technique, safeguards and random checks would have to be implemented to advert unintended batch number changes.

Special consideration should be made to ensure manufacturing equipment is constructed of proper materials which suit the range of processes and materials that manufactured on site. Construction materials should not interfere, corrode, or deteriorate in anyway which could influence manufacturing or testing procedures.

Equipment Layout: Equipment arrangement and location should minimize risks of product cross-contamination. Intricate equipment should be arranged in location and position to ease facility maintenance and allow effective cleaning techniques to avoid potential build-up for dust or dirt.

Equipment Maintenance: Proper equipment maintenance is necessary to ensure that equipment is prepared to fully function the correct way. There should be regularly scheduled maintenance dates and times for major pieces of equipment. Logbooks or software should be used to record equipment use, scheduled prevent maintenance, and timeframes for regularly scheduled upkeep. Depending on the age of equipment, more or less maintenance may be required to reduce quality issues. Commonly tablet presses provide manufacturers with issues. As the tablet machine ages, malfunctions could result in an output of out-of-specification tablets.

Production Equipment: Materials must not be reactive with the processing equipment. Often, this means that very high quality stainless steel or another suitable material must be used. Additionally, construction materials should not present hazards to products that are being manufactured, such as a reaction or unintended absorption between the produced product and the manufacturing equipment. Commonly, plastics or materials containing plasticizers often are absorbed or are seep into unintended materials and products.

Equipment Cleaning: Equipment used for production must be regularly cleaned even if it is exclusively used to produce one product. Regular cleanings is even more important for equipment that is used to product a number of different products. Equipment should be easily taken apart and designed to allow all crevices and surfaces to be cleaned thoroughly and visually inspected.

Proper cleaning procedures should be documented, especially for equipment which produce numerous products that need different cleaning techniques. It is important to review SOPs and verify cleanings are being conducted regularly and properly to ensure complete compliance.

Cleaning methods should be validated for effectiveness, and then written in the form of SOPs which should include every step and cleaning process. Extra tests should be conducted if the cleaning process includes the use of compressed air, brooms, or brushes. Compressed air is commonly used to move dust and dirt from some crevices; however, the air is uncontrollable and often just pushes the dust and dirt to other areas and equipment. The same results are common for brushes and brooms.

Cleaning records should be logged and documented. When cleaning is done as a part of production, the batch numbers of the products produced on the equipment should also be recorded.

The InstantGMP™ MES contains software logs which allow anyone to verify that equipment has been properly cleaned and maintained, or if the equipment is cleaned and ready for production of a new batch or product. These logs can be adjusted to meet manufactures needs, such as providing a convenient place to record preventive or regular maintenance.

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