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We have all heard of the good manufacturing practices (GMPs) regulations proposed for dietary supplements by FDA. We have also heard all of the dates that these “proposed” regulations will be published in the Federal Register and eventually in the Code of Federal Regulations, which will change the proposal to a law. Many dietary supplement manufacturing companies fear that this new law, when approved, will hinder operations, making it more difficult to perform to their customers’ expectations, and will make their operations more costly.
In some cases, the costs of doing business will increase. However, many companies will make the new regulations work to their advantage. In fact, many companies have found that following stricter guidelines has actually increased productivity and improved product quality while decreasing expensive rework.
HISTORY OF THE DIETARY SUPPLEMENT MANUFACTURER
To illustrate how this can happen, we must go back to the birth of the dietary supplement industry and follow the path that led up to today’s dietary supplement manufacturer. Originally, dietary supplements were manufactured by pharmaceutical companies. These companies were in the business of producing drugs. They became very aware of the costs involved in poor planning which resulted in poor quality. Most drug manufacturers invented ways of checking each of the manufacturing processes leading up to the finished product in an attempt to identify problems before the products were finished.
Eventually, in the 1970s, FDA came up with the GMPs for drugs. At that time, very few companies manufactured only dietary supplements. Virtually every bottle of vitamins or minerals a consumer could buy in any store was still being made by a pharmaceutical manufacturer. Products like Bayer Healthcare’s (Morristown, NJ) One-A-Day, GlaxoSmithKline’s (Research Triangle Park, NC) Geritol, and Wyeth Consumer Healthcare’s (Madison, NJ) Centrum are still made by pharmaceutical manufacturers today. A few companies such as Nutrilite (Buena Park, CA) and Shaklee (Pleasanton, CA) had ventured into the dietary supplement manufacturing industry, but they sold their products using exclusive marketing techniques, not through the mass market. Even then, Shaklee, as well as others, contracted the services of pharmaceutical companies to produce many of their products.
During the 1970s and continuing through the 1990s, companies were created with the sole purpose of manufacturing dietary supplements. This took place during much growth in the demand for dietary supplements. Many manufacturing companies were created out of the needs of marketing companies that handled the promotion, sales, and distribution of the products. Unfortunately, the growth of the industry was far too great for the small manufacturers to worry about things like GMPs. These small manufacturers eventually became large manufacturers with no established foundation (or organization) to help control the inner workings of their businesses.
Competition continued to force companies to concentrate on production levels and delivery times rather than on organized planning and quality issues. This caused many quality concerns that eventually became public and in turn damaged the industry’s reputation. How did those large pharmaceutical companies make dietary supplements and make a profit? They followed an organized plan that worked for all products, dietary supplements and drugs alike.
PLANNING IS THE KEY TO PRODUCTIVITY
The normal process in starting a business is to research the type of business one desires to operate. Then, a business plan and organizational plan are developed. The business plan is composed of many models of expectations and risks, and it usually determines the amount of financing needed to get started. The organizational plan basically builds the foundation for how the operation will function.
Most companies entering into the dietary supplement industry fail to create one or both of these plans. Assuming that financing is not a concern, a company will be very limited in running a successful operation without an organizational plan. An organizational plan will include how orders will be received from customers, how customers will be billed, how raw materials will be ordered, how the products will be produced, and who will handle these tasks, among many other aspects of day-to-day operations.
The organizational plan is the most important plan in making a company into a success. Once it is in place, only slight modifications may be necessary to ensure that the company runs efficiently. GMPs are an integral part of the organizational plan, even if they are not required for dietary supplement manufacturing. Such a plan is based on internal “laws” created to help ensure the company’s success. Those laws are the company’s standard operating procedures (SOPs).
PROCEDURES CREATE A STATE OF CONTROL
Can a company operate without SOPs? The answer is yes, but that company’s efficiency and product quality will suffer. Many companies maintain operations without a strong set of operating procedures. However, companies that have revised their operations have, for the most part, experienced tremendous increases in productivity and better quality. In some cases, productivity rose by as much as 300% without additional equipment or personnel. This growth is directly attributable to the efficiency created by well-written procedures and well-conducted procedural training.
In essence, drug GMPs and the proposed GMPs for dietary supplements support the simple idea of a state of control over a manufacturing facility. In other words, FDA wants each company to develop a binding set of laws that will be enforced by the company to ensure that a plan is in place and followed. This plan (or set of procedures) will ensure that the successful performance of processing a product can, and will, be duplicated to produce the same quality results each time the product is manufactured. A company that captures this concept will be more successful than a company that does not, simply because it is well organized.
How can an existing company that did not build an organizational plan build one now without hindering ongoing operations? The answer may be simpler than expected. According to the GMPs for drugs and the proposed GMPs for dietary supplements, all procedures must be drafted, reviewed, and approved by the appropriate organizational unit(s), and reviewed and approved by the quality control unit (QCU). The key to this requirement is identifying or defining the “appropriate organizational unit.” What FDA means by this is, “Who will be responsible for following the procedure(s)?” If a procedure is created for a process to be completed in compounding, then the appropriate organizational unit will be compounding or someone who is responsible for compounding.
BUILDING A PROJECT FOR SUCCESS
A successful approach to creating the necessary procedures is to have a project organized just for that purpose. The person who manages the project must be well versed in what a well-written procedure looks like. Others involved in the project will be representatives of the involved departments where procedures are necessary. The idea is to have the employees themselves write the procedures. The project manager will ensure that the formats are correct and all requirements for the procedures (according to the GMPs) are met. The QCU (usually quality assurance) will also review and approve all procedures. The purpose of the QCU review is to ensure that GMP requirements are met and to ensure that the procedure is written in a way that will protect the quality of the product.
The focus on complete written procedures must be maintained, but at no point can a company claim they have finished writing procedures. Writing procedures is not something that has a deadline; it is a continuing function of doing business. Procedures are living documents that evolve to become more and more efficient within a company’s operation. Beyond just the writing of procedures is the training of the employees on those written procedures. Procedures are not meant to sit on the shelf. They are to be used as tools for training the employees, and to continue to be used as a reference guide in each phase of the operation. Training must be adequately sufficient and frequent enough to ensure that employees remain familiar with all procedures related to their job(s).
To ensure that each procedure accurately portrays the actual methods used during processing, each procedure must be validated. This simply means that if the procedure is followed as written, the results are as expected. There is little need to create a formal validation protocol for every procedure, especially for those procedures that will be followed frequently on a day-to-day basis. It won’t take long to discover if such a procedure might fail to produce the expected results. Some procedures, however, must be officially validated, and documents proving validation must be created. Cleaning procedures are a good example of procedures that must be validated.
Keep in mind that the proposed GMPs for dietary supplements and the GMPs for drugs refer to “procedures.” In fact, the regulations do not make mention of SOPs. What this means is that a company will have different types of procedures. SOPs are those that are followed as a standard and are written to ensure that machines are cleaned in a consistent manner, samples are taken in a consistent manner, yields are checked in a consistent manner, etc. Procedures particular to single product are not considered “standard.” Therefore, each batch has a set of procedures necessary for producing that product that may not work for other products. Do not try to include SOPs in batching procedures or try to include batching procedures in SOPs. Doing so will definitely create confusion and hinder productivity.
TAKING ADVANTAGE OF GMPs
Yes, companies can take advantage of FDA’s GMPs. The good thing about being in a regulated industry is that things are written in black and white. A well-organized company knows what it is doing and exactly how it does it. Mistakes and poor quality are not mystical in their origin. They have their roots in poor planning and the absence of policies or procedures. Companies that build an organizational foundation are more successful. They make a better product with better efficiency, thus making a better profit. Success is always preceded by good planning.
In today’s world, customers look for the systems within a company that will ensure quality products. This is especially true with contract manufacturers. A customer of a contract manufacturer will usually conduct an audit to ensure that the contract manufacturer follows a regimented GMP program. This audit will always include the contract manufacturer’s organizational plan, which includes the company’s SOPs. Being prepared in this area is the key to gaining a potential customer’s business, as well as maintaining that state of control over the processes and quality of the products a company will produce.
A company that maintains a state of control and promotes and enforces regulations, procedures, and policies is a company that produces high-quality products in the most efficient manner with the least amount of mistakes and rework. In other words, that company is highly successful.
Gary Callahan, senior vice president of Robinson Pharma’s (Santa Ana, CA) drug division, has more than 35 years of management experience in the pharmaceutical 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 has managed key projects resulting in four state-issued drug licenses for four different drug manufacturing companies in California. He is also the author and course director of the two-day short course, “Writing SOPs for cGMP Compliance,” which is offered through the Center for Professional Advancement (East Brunswick, NJ) in association with the Center’s Institute for Applied Pharmaceutical Sciences. The course is recognized by the International Association for Continuing Education and Training (McLean, VA), the Society of Manufacturing Engineers (Dearborn, MI), the American Society for Quality (Milwaukee), and the Accreditation Council for Pharmacy Education (Chicago).