On July 24, 2012 the FDA issued a Warning letter to United Nutrition Labs for continually failing to comply with current Good Manufacturing Practices (cGMPs) after a thorough on-site inspection. The company was cited for a number of cGMP violations including the following:

• Failure to establish finished product specifications for identity, purity, strength and composition of finished products.
• Failure to conduct identity testing of raw materials.
• Failure to include evidence of sampling in Master Manufacturing records (MMRs).
• Failure to calibrate instruments either according to manufacturer specifications or at regular intervals to ensure equipment is operating within pre-determined specifications.

In addition to the above observations, the responses provided by the company to FDA form 483 were deemed to be insufficient or inadequate. This included failure to implement Standard Operating Procedures (SOPs) to address the lack of finished product testing, despite responding to the FDA Form 483 indicating otherwise. Additionally, it was noted that this firm’s Quality Assurance person was not equipped with the appropriate combination of education, training and experience to adequately perform their duties. This last point should be viewed as the most important since the deficiency in the education, training and experience of the Quality Assurance person was directly responsible for this company’s lack of compliance with cGMPs.

How do you avoid a Warning Letter? By ensuring your employees are qualified to perform their positions through an on-going cGMP training program. Current good manufacturing practices (cGMPs) are general guidelines of best industry practices that are part of the overall quality management system of a company as set out by the FDA under 21 CFR part 111 for dietary supplements. It is important to note the use of the word “current” indicating that cGMPs are dynamic and are constantly evolving to keep up with the demands of an ever-changing industry. As such, it is necessary for an effective GMP training program to also be kept current to ensure that employees are up-to-date on the most recent changes to cGMPs. Oftentimes companies fall into the trap of either instituting an ineffective cGMP program and/or one that is not on-going (“we trained our staff once 10 years ago, isn’t that sufficient!”). The FDA indicates that it is the responsibility of the company to ensure that all employees are qualified to perform the tasks outlined in their job description through a combination of education, training and experience – this includes on-going cGMP training. As cGMPs are the backbone of the dietary supplements industry, the onus is on the company to determine the level and frequency of cGMP training that an employee requires. For example, an employee that works directly with the manufacturing of the product may be required to attend intensive biannual cGMP training sessions, while someone in management may only need to attend a yearly refresher. Those who have direct contact with the product, through either material or process control, should be refreshed and kept up-to-date on any changes in the regulatory environment. However, it is also very important for management to be onboard with an on-going cGMP training program and make it part of the corporate culture in order for staff to buy in to the program.

At dicentra we understand that a company may not have the time, resources or knowledge to implement an effective cGMP training program. To address this dicentra can either act as your formal Quality Assurance Person or can assist your company in developing a comprehensive cGMP training program. Remember, quality cannot be tested into a product, but must be “built in” through the implementation of cGMPs from the beginning to the end of your product lifecycle.

dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or at dicentra.com

References:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm313468.htm