How to Select and Qualify a Contract Laboratory

EAS Webinar Series on GMP Compliance in Dietary Supplement Laboratories

Back by popular demand – Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. will discuss Good Manufacturing Practice (GMP) compliance in the dietary supplement laboratory. This series, originally run in 2015, will discuss various aspects of regulatory compliance with 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, as it pertains to laboratory operations.

This series is a great opportunity to learn how to maintain a laboratory facility with effective laboratory controlled processes as well as evaluate your contract laboratory for the same. Participants in this webinar will get a basic understanding of the available analytical techniques and test methods; and when they are appropriate to establish that dietary ingredient and dietary supplement product specifications for identity, purity, strength, composition, and potential contaminants have been met.

Each one-hour webinar replay

  1. 21 CFR 111 GMP Laboratory Overview [View]
  2. Using Analytical Instrumentation Appropriately [View]
  3. What is a Scientifically Valid Method? [View]
  4. Developing Compliant Specification – No “By Inputs” Here [View]
  5. How to Select and Qualify a Contract Laboratory [View Below]


Tara Lin Couch, Ph.D.
Senior Director of Dietary Supplement and Tobacco Services

EAS Senior Director for Dietary Supplement and Tobacco Services, Dr. Tara Lin Couch is a Ph.D. Analytical / Organic Chemist with exceptional analytical abilities and over 25 years of diverse laboratory and regulatory experience in academic, field, contract, and manufacturing environments. She is a sought-after expert on issues pertaining to Quality Control in both pharmaceutical and dietary supplement manufacturing facilities including the establishment of specifications and the development of well-organized, sophisticated laboratories. As a consultant, Dr. Couch has assisted numerous dietary supplement companies with the development, improvement, and implementation of strong Quality Systems that are scientifically sound, efficient, practical, and compliant with all FDA regulations. She also performs mock FDA inspections, gap-analyses, and contractor facility audits. In addition, Dr. Couch provides GMP and laboratory training via seminar, webinar, and on-site presentations.

The Role of Regulatory Affairs in Product Development

Neil Smith and Sandy Brand, Independent Consultants, EAS Consulting Group, LLC


Prepared by: Neil Smith and Sandy Brand, Independent Consultants, EAS Consulting Group, LLC

November 2, 2017

Regulatory Affairs touches each and every product within a company, ensuring compliance with local regulations and internal policies and the creation of sound guidelines related to labeling, safety, and nutrition. Through the strategic links to trade associations, Government agencies, and NGO’s the business is kept abreast of all changes in regulations that may affect the business, as well as key developments in science, based upon which regulatory affairs professionals provide direction on the product development process so that the business achieves the best outcome.

Proactive Regulatory Affairs professionals should provide strategic and technical advice to all levels of the business and at all stages of the product cycle, from ideation or concept discussions through to commercialization, and beyond. Conversely, proactive engagement with Regulatory Affairs by all levels within the business ensures decision making that is consistent, timely, and accounts for all factors.

White Paper

FDA Issues Guidance on Facilities Exempt from CGMP and Preventive Controls

One of the first steps for assessing a facility’s compliance status under the rules implementing the Food Safety Modernization Act is to consider whether the facility is required to comply or if it may qualify for an exemption, however narrow it may be.

As a simple rule of thumb, if a food establishment is required to register with the agency, it is required to comply with FMSA rules. But some registered facilities may qualify for exemptions from some requirements. The FDA released draft guidance last month on exemptions for “solely engaged” facilities from the current good manufacturing practice (CGMP) and preventive controls requirements in 21 CFR Part 117 or Part 507.

For example, an establishment that exclusively holds raw agricultural commodities (RACs) — other than fruits and vegetables — for human and animal food use, hulls or shells nuts, and does not engage in any other activities covered by the CGMP requirements in Parts 117 and 507 is exempt from the CGMP requirements.

Similarly, if all activities performed by a facility are exempt under one or more preventive controls exemptions, the facility is not subject to the Part 117 and/or Part 507 preventive controls requirements. But if any part of a facility is engaged in an activity subject to the CGMP or preventive controls requirements, the entire facility is then subject to CGMPs, the preventive control requirements, or both, the agency said.

A facility that stores unexposed, packaged human and animal food that does not require time/temperature control, stores grain RACs intended for further processing and distribution, and does not engage in any additional activities covered by the preventive controls requirements is exempt from the preventive controls requirements. However, a facility that stores unexposed packaged human food that does not require time/temperature control but also cuts vegetables – that is, manufactures/processes food – is not “solely engaged” in activities exempt from the preventive controls requirements, so it must comply with the preventive controls requirements in Part 117.

The agency also issued final guidance in October on Current Good Manufacturing Practice Requirements for Food for Animals. The guidance emphasizes the “flexible” nature of the CGMP requirements, and says there may be significant differences in how CGMPs are implemented in facilities where undesirable microorganisms are a food safety concern for the type of animal food produced compared to facilities producing an animal food for animals that are not as likely to be affected by undesirable microorganisms.

This means animal food companies must implement appropriate CGMPs for their unique facility, the type of animal food, and the animal(s) for which they are producing.

There are a number of FSMA initiatives coming out of FDA, the requirements of which can be confusing, particularly in the case of those companies which are authorized an exemption. Greater details on exemptions can be found on FDA’s website. Those companies wishing to discuss their particular circumstances may wish to contact a consulting firm such as EAS to learn more about which rules of FSMA apply.

A Look at the Regulation of OTC Sunscreen Formulations

The process of developing and testing a sunscreen is not unusually difficult but it does require close attention to the regulations and coordination with the testing laboratory preparing the efficacy data.

Sunscreens may be part of a cosmetic line and those that are intended to provide protection from incidental sun exposure during the normal day’s activities are often called “cosmetic sunscreens”. On the other hand, sunscreens intended to provide protection from prolonged sun exposure activities such as beach, pool, or other activities where sun exposure is high and resistance to water or perspiration is required. These products are often called “active or sport” formulations. The formulation requirements for each class are slightly different but the underlying regulations for the products are the same.

In the United States, sunscreens and several other categories of functional products are regulated under the over-the-counter (OTC) drug regulations of the Food and Drug Administration (21 CFR 352). These regulations define the allowable active ingredients (termed UV filters) and their maximum use concentrations, the performance testing required to establish the efficacy of the product (SPF, Broad Spectrum coverage, and water resistance), and labeling of the product.

An important concept of the OTC program is that the active ingredients used in the formulation will be considered safe provided that the regulations are followed. Therefore, the individual new formulation does not require approval from FDA. The specific OTC drug regulations for sunscreens are unique to the United States, but many of the same principles apply in many markets. In the European Union, sunscreens are regulated as cosmetics (for labeling) but certain restrictions for active ingredients and testing apply.

In all major markets, the active ingredients that can be used as UV filters are prescribed by positive lists (that is, only ingredients on the specific list for that market may be used). The maximum concentration of each active ingredient is also indicated. These lists for both specific ingredients and maximum concentrations are not the same across markets. Thus, a product prepared for one market may well not be acceptable in another. For example, the United States has a shorter list of approved UV filters than does the EU and so many EU products are excluded from the U.S. market.

A functional sunscreen formulation is not simply the sum of its active ingredients. If it were, efficacy testing would be rather easy. The remaining ingredients, termed inactive ingredients under the regulation, are essential not only for the aesthetics of the product but for its efficacy as well. To function effectively, the formulation must hold the UV filters in a film on the surface of the skin. The film holds the UV filters to form a “tortuous path” through which the UV light must pass. The filters scatter and absorb the UV light attenuating exposure to the skin below. Since the surface of the skin is not flat, the formulation must form a film that can cover the skin peaks and valley to block the UV light.

While the formation of a surface film is required for function, it can impact product esthetics. Cosmetic sunscreens, such as facial moisturizers, are intended for incidental UV exposure with limited water or perspiration exposure. These products may be successful with less robust film former. Active or sport formulation require considerable water resistance (once they have dried on the skin) and so need more robust, less water-soluble film formers.

In summary, to ensure regulatory compliance of OTC sunscreen formulations, it’s important to closely follow the regulatory and testing requirements.