Understanding the Relationship between GMPs and Adulteration
25 September, 2014 Marc C. Sanchez, Contract In-House Counsel & Consultants, LLC
Good Manufacturing Practices (GMPS or cGMPS) are a bit of a misnomer. The name implies the practices only apply to manufacturers, but the limitation is in name only. It suggests a rigid system of procedures more suitable for multinational corporations than start-ups, mid-size companies, or importers. In truth GMPs are policy goals that do not specify how an activity is done, just the result it should achieve. The name also lacks any link back to the overarching purpose of the practices. GMPs are not a scoring or rating system. Instead GMPs are a crucial link to avoiding adulteration and ensuring quality. The practices set a floor or safety net of minimum facility sanitation practices to ensure cosmetics are not indirectly contaminated. It also establishes a consistency that secures quality. GMPs are oft cited by the FDA following facility inspections in Form 483s and Warning Letters because it provides a window into the culture and compliance mindset of a facility. That mindset suggests the likelihood of adulteration or larger compliance violations.
GMPs Control Indirect Adulteration
|GMPs are policy goals that do not specify how an
activity is done, just the result it should achieve.
The name also lacks any link back to the overarching
purpose of the practices.
It is important to begin with the basics. To understand the role of GMPs and adulteration a few definitions and regulatory concepts must be defined. This discussion will not involve the other common violation for cosmetic products of reclassification as “new drugs” based on labeling claims. That is a form of misbranding one of the two major prohibited acts. Instead the focus is on the other major prohibited act – adulteration.
Adulteration is a multilayered concept. The Food Drug and Cosmetic Act (FD&C) defined the term in 1938 and it has remained that way ever since. The Act defines adulteration in five parts in Section 361. Each part describes a different way a cosmetic may be adulterated, such as with unapproved color additives. Of the five, two parts address indirect adulteration. Subsection (b) describes the scenario where the cosmetic becomes contaminated with “filthy, putrid, or decomposed” substances. Subsection (c) directly tackles a cosmetic “prepared, packed, or held under insanitary conditions.” Both of these subsections provide the framework for indirect adulteration and GMPs.
Indirect adulteration refers to the range of activities occurring around the production, storage, or distribution of cosmetics. The concept captures the idea that the environment in which cosmetics are manufactured and held can contribute to the safety and integrity of the product as much as adulteration through unapproved ingredients. Thus, manufacturers, distributors, importers, shippers and others all play an equal role in contributing to adulteration. Indirect adulteration cannot be captured on a label or website meaning the consumer trusts the product is pure and safe. Whether or not they know it consumers rely on GMPs every time they buy a cosmetic. It is the invisible link of trust that makes adverse events particularly damaging.
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Indirect adulteration is subject to several controls. Indirect adulteration may involve chemical, physical, or microbiological hazards. Chemical hazards, for example, could involve the storage of cosmetics near cleaning supplies or pesticides. Physical hazards run the range from flakes of metal or plastic to lost latex gloves. Microbiological hazards are perhaps the best known. Pathogens can enter a product from a number of sources including employee health and hygiene to facility conditions that allow standing water to pool. No matter the type of hazard GMPs offer a control and verification activity to safeguard against potential adulteration. GMPs should therefore be seen not as a compliance hurdle, but as a risk reduction strategy.
GMPs Signal the Compliance Culture of a Facility
Form 483s and Warning Letters often cite GMPs violations because a poor compliance program indicates larger issues. Form 483s are a statutory creature created in 1953 under the Factory Inspection Amendment. The Form 483 as a matter of law must list observations related to adulteration and misbranding. GMP violations, however, are listed as a matter of policy. GMPs are cited because the procedures serve as an indicator of noncompliance. Whether a formal Standard Operating Procedure (SOP) or informal company policy is followed the FDA is looking for assurances the cosmetics manufactured, stored, and distributed by regulated parties are safe. GMPs and good recordkeeping practices provide that assurance.
GMPs also act as indicators of the compliance culture adopted by a facility. No matter if the policies are formal or informal evidence of a proactive compliance culture provides confidence to the FDA. An awareness of quality controls and the regulations suggests a facility firmly in control of its processes and products. GMPs are an outward objective measure of that awareness and culture. It provides the FDA the first indicator that adulteration is likely controlled to the extent possible. GMPs still must be followed, in particular record keeping provisions, and gaps in a GMP program could raise the alarm of possible violations. Adoption of a program nonetheless provides insight into how a facility views the regulations and the risks of adulteration.
Contractors and Criminal Liability
GMPs, even if not followed by a contract manufacturer, can be the source of criminal liability. It sounds sensational or even far-fetched to believe failure to follow GMPs could result in criminal misdemeanor or felony charges. Yet the case law supports it. Under what is known as the Park Doctrine a corporation and its officers may be liable for FD&C violations without intent of wrongdoing, participation in the violative act, or awareness of the acts. Simply being a corporate officer when the violations occur is enough to be personally criminally liable. The doctrine is one of absolute liability, meaning it dispenses with criminal intent and participation. It is also a doctrine of vicarious liability, which allows prosecution for the acts of others. Cases for cosmetic companies tried for criminal violations go back as far as 1943.
Beginning in 2013 the FDA began citing the threat of criminal penalties under the Park Doctrine in Warning Letters. All of the Warning Letters citing the Park Doctrine point the facility’s attention to its potential liability for for the acts of its contract manufacturers. Importers and private labelers of cosmetics should take note. If GMPs do not serve as a basis for criminal penalties, then the adulteration or misbranding created in their absence will. GMPs serve many functions, including guarding against the most severe form of regulatory enforcement – criminal prosecution.
GMPs Offer Consistency to Current Practices
GMPs capture activities likely already performed. Clients are often surprised to learn many GMPs simply formalize policies already in place. For example, nearly every cosmetic seller maintains a customer care department to answer consumer questions, manage refunds, or respond to product problems. A compliant GMP program also requires monitoring consumer feedback to determine whether the issues raised requires regulatory action, such as a market withdrawal or FDA notification. In this example the SOP simply formalizes the process, ensures it consistently occurs, and uniformly generates a record of occurrence. Thus if the FDA were to conduct an inspection the consumer feedback log could be provided as evidence of monitoring consumer calls for potential product issues. An absence of documented complaints strongly supports the argument that adulteration is in check. The same can be said about proper storage, manufacturing and distribution of cosmetics.
Records are perhaps the most important element of a GMP program. The FDA holds to the mantra, “If it is not recorded, it did not happen.” This often renders informal compliance programs in effective. Informal programs may be word-of-mouth or simply a habitual practice. Informal compliance programs may not generate records or may not do so consistently. Gaps in records can be just as damaging as no records at all. Records become particularly important during either a routine surveillance inspection or a for-cause inspection resulting from some adverse event. If records cannot be produced to show quality checks for the production or storage facilities or for the processes that could introduce contaminants, the FDA must assume a risk of adulteration is present.
GMPs can be flexible. Often the fear of adopting a GMP program lies in the misconception the protocols will impose burdensome costs. Typically the thought is the GMP will set a high bar for how a particular activity must be performed. In truth GMPs simply set out broad goals, such as maintaining the facility in a manner to protect against indirect adulteration. This can be done in a myriad of ways, including some activities routinely carried out by a facility. The GMPs do not stipulate how an activity must be done, but simply sets out the goal it should accomplish and the records to attest to its completion.
GMPs Provide Peace of Mind
A FDA inspection or worse a consumer adverse event can induce panic and unnecessary fear. GMPs provide a structure to manage inspections, recalls, and complaints. Structure can provide a sense of calm and order. GMPs also provide the peace of mind that the products are pure and safe for use because quality checks are routinely performed. The more sophisticated the GMP program the greater the assurance. Even a basic GMP program instills confidence that a facility did not contribute to the adulteration of cosmetic products. This confidence will provide a solid basis to interact with the FDA and ample grounds to protect a brand from negative publicity. It is not only recalls that are public, but Warning Letters as well.
Adulteration is ultimately the link to GMPs. A properly implemented GMP program manages the risks of indirect adulteration and promotes a culture to guard against direct adulteration. At its core GMPs are aimed at controlling indirect adulteration from pest control to storage and distribution practices. More broadly GMPs serve as an indicator of the compliance culture of a facility. GMPs are often misunderstood. Rather than a costly barrier, GMPs offer an opportunity to ensure quality, reduce risk of regulatory actions, and protect a brand. GMPs apply up-and-down the supply chain, but offer the flexibility to apply to large and small facilities. Rather than wince at the notion of adopting a GMP program, open your eyes to the singular chance to protect consumers to protect the brand and avoid unnecessary regulatory enforcement actions.
Marc C. Sanchez is the founder of Contract In-House Counsel and Consultants, LLC. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device and drug industries. With a focus on international trade, he advises clients on the regulatory requirements and strategic corporate considerations that affect the importation, distribution and exportation of FDA regulated products. Marc is a frequent national speaker on FDA compliance issues and is considered a leading voice in understanding the Food Safety Modernization Act, which has fundamentally changed food law in the U.S., with interviews and contributions in the Washington Post and Huffington Post. He is also the author of two textbooks, including Springer International’s first food law text.
Sanchez received a Masters in International Commercial Policy from Valparaiso University and earned his J.D. from Lewis and Clark College. He is a member of the Washington Bar Association, Food Drug and Law Institute, and Regulatory Affairs Professional Society.
To learn more about Marc’s practice, visit his website at www.fdaatty.com or email him at firstname.lastname@example.org.