It’s been eight years since FDA published its final rule regarding GMPs (good manufacturing practices) for dietary supplements. Still, this late in the game, many are perplexed about what the regulations are asking for.
There are still companies that believe they are doing everything in a way that FDA will approve of, even if they aren’t exactly in line with the GMP regulations. Other companies dive head first into dissecting the regulations and come up with their interpretation of the meaning of GMPs. And finally, there are companies that rely on the interpretation of the GMPs by organizations that never manufactured any product, much less a dietary supplement or drug product. Do any of these scenarios sound familiar?
GMPs are not meant to be magical or mystical or even difficult to understand. The key to success for any company (in any industry) is the planning of the operation and the execution of those plans. FDA is actually looking for just one thing … a “state of control." So what is that elusive state of control? Simply put, companies are required to establish a “Production and Process Control System." Oops! Did I just mention what is covered in Title 21 of the Code of Federal Regulations, Part 111, subparts E, F, G, H, I, J, K and L? These subparts all cover the requirements to have a production and process control system.
The backbone of a production and process control system is the standard operating procedures (SOPs). The GMP regulations emphasize the requirement for written procedures in every subpart, with the exception of subparts E, H, I and L, which refer more to documentation. It is obvious that poorly written procedures or not having procedures at all is the main contributor to the lack of compliance by companies and regulatory action seen from FDA. Well-written procedures are the tools that make a company not only become compliant, but also more successful in their everyday operations.
So, what is a well-written procedure? First, never write a procedure to satisfy a GMP requirement. That’s right. Procedures are written to give control over the company. FDA wants companies to build in those things that will aid in that control. Specifications for raw materials and components, master manufacturing records (MMRs) to ensure the product will be produced the same way each time, and testing for verification of meeting specifications at each significant phase of processing are all ideas to ensure products are of the same specified quality and content every time they are manufactured.
Keeping this in mind, the next step is to focus on the best content for each written procedure. Procedures need to be easy to follow. Procedures need to be descriptive enough to ensure employees will understand and follow them. Procedures need to be written in a step-by-step format. Most of all, procedures need to be simple. FDA will tell you the same. Too often, companies write SOPs as if they are trying to impress the most intellectual minds. The problem is, no one can understand them, not even the intellects. So the first rule is to KISS: Keep it Simple … Friend.
After that, consider what SOPs should be included in your operation and what SOPs are there for show or fluff. Many companies write procedures and use them as “window dressing." They believe they can put the SOPs aside so they can produce more quickly. Then, if FDA comes along, they can show them all of these impressive SOPs and the inspector will think well of the company. WRONG! Think of SOPs as the laws you established to govern company, and FDA as the law enforcement organization that can—and will—enforce those laws. Therefore, do not write to prove that you have overkilled the GMP requirements. Remember, these are procedures that will ensure the control of your facility. Write them to serve you, not FDA. Just make sure to include the requirements stated in the GMPs.
Finally, be cautious of what so-called GMP experts and organizations say must be included in your SOPs. If it is not outlined in the actual GMPs, don’t make up additional regulations that can’t be found anywhere. What might these be? For example, nowhere in the GMPs does it require “job descriptions." While some will refer to 21 CFR 111.12 and 111.13 or 111.14, these sections do not require “job descriptions." SOPs are description enough to direct your employees. At most, I would recommend “job specifications," which simply state the requirements (i.e., experience, degree, etc.) to obtain a particular position. Another misnomer is delivering truck inspections; this is not a GMP requirement. While some may think it makes good sense, realize the delivering truck only came from the local warehouse to your facility. Before that, your materials were in a warehouse that holds all kinds of goods, not just foods or dietary ingredients. And, other trucks were involved before the warehouse. Who knows what they looked like? The last misguided direction by many has to do with the qualifying of suppliers. The GMPs do not require you to audit a supplier of raw materials. FDA simply wants you to build confidence in the certificate of analysis supplied by your supplier.
In summary, SOPs represent your production and process control system. Make them work for you.
Gary Callahan has more than 40 years of hands-on and management experience in the pharmaceutical and dietary supplement manufacturing industry. Throughout his career, he has implemented many GMP and SOP programs in several different companies to meet compliance standards set by FDA. Callahan holds a bachelor’s degree in business administration and a master’s in business management from Almeda College and University. He has also worked on the research and development of new drug products at the University of Iowa, School of Pharmaceuticals, and has been licensed by the California State Board of Pharmacy.
Looking for more information on GMP Compliance?
Gary Callahan will speak on “The ABCs of GMP Compliance (KISS)" as part of the GMP Workshop at SupplySide West. The three-hour workshop will take place on Friday, Oct. 9, at Mandalay Bay in Las Vegas. Visit http://west.supplysideshow.com/workshops.aspx for the complete agenda and to get registered.