What is a Scientifically Valid Method?

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 Below]
  4. Developing Compliant Specification – No “By Inputs” Here [View]
  5. How to Select and Qualify a Contract Laboratory [View]

Instructor:

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.

Using Analytical Instrumentation Appropriately

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 Below]
  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]

Instructor:

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.

21 CFR 111 GMP Laboratory Overview

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 Below]
  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]

Instructor:

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.

FDA Proposes Four-Year Compliance Delay for Produce Rule’s Water Standard

FDA issued a proposed rule September 13, 2017, that would extend the compliance dates for agricultural water requirements in the Produce Safety Rule, giving the agency four years to reconsider the water standards to ensure that they are feasible.

FDA Commissioner Scott Gottlieb hinted at a possible “course correction” in relation to the water standards, in a presentation last month at the National Association of State Departments of Agriculture annual meeting in New Orleans.

The agency has gotten the message from stakeholders that the microbial quality standards for agricultural water are “too complicated, and in some cases too costly, to be effectively implemented,” he said.

Under the proposed rule, the earliest non-sprout compliance date for the water standards won’t be until January 2022.

In another announcement, Gottlieb said the planned 2018 produce inspections by states under agency-funded cooperative agreements will not begin until spring 2019. He urged the states to use the 2018 cooperative agreement funding for On-Farm Readiness Reviews — voluntary farm visits by a team of state officials, cooperative extension agents, and FDA produce experts, to give farmers an assessment of their “readiness” to meet the new requirements.

NASDA and FDA have already pilot-tested On-Farm Readiness Reviews in six states, and they are planning to roll out the program nationally this fall.

A NASDA-FDA working group formed to work on plans for training state and federal inspectors recently piloted a regulator training course. The agency has four regulator training courses planned for 2018, Gottlieb said. “We’re committed to offering more training courses before the start of inspections to ensure we train inspectors to meet these needs,” he said.

The agency is also growing its Produce Safety Network of FDA produce safety experts located across the country.

FDA is still working on “a rather large guidance document” on the Produce Safety Rule and Gottlieb said he is aware there is “some frustration that this guidance has not come out yet.” He said the agency now expects to publish the draft guidance early next year.

Gottlieb also noted concerns raised regarding the use of traditional Form 483 reports to document regulatory issues during produce inspections. The agency is “planning to explore additional ways of communicating our concerns about what we observe during produce inspections,” he said.

In response to requests from stakeholders, the agency also has listed eight additional water testing methodsas equivalent to the method incorporated by reference (Method 1603) in the Produce Safety Rule and it and intends to add other methods to the list as they are identified, he said.

Finding the correct balance between food safety and real-world irrigation practices when growing produce, domestic and foreign, has presented FDA with significant regulatory challenges. The extension in the dates for compliance with agricultural water requirements gives the agency more time to accomplish internal produce rule preparations, and allows produce growers more time to adjust irrigation practices if they prove to be needed.

U.S. Dairy Industry Challenge – How Many Food Safety Plans Are Enough?

The U.S. dairy processing industry is facing a significant challenge as it moves toward compliance with the FDA Food Safety Modernization Act (FSMA). This is best captured by a conversation I had with a corporate quality assurance vice president about six months ago. When asked how many written food safety programs each of the dairy plants in his company had, the reply was, “Because of the current regulations, private certification systems, customer expectations and our own corporate food safety requirements, the number ranges between three and five per plant.

I asked how they could manage this number of different food safety programs, which one(s) the plant employees were trained on and how they kept the records required for each written food safety program separated and organized. While he may have had a solution, he did not provide an answer to my question. The challenge is exactly that; with so many demands on dairy plants today to operate in a multi-jurisdictional government world, a multiple customer world and competing, private food safety standards, can one written food safety program meet the requirements for all these different parties?

For many U.S. dairy processing plants, because of industry consolidation, their compliance enforcement deadline for the FSMA “Preventive Controls for Human Foods (PCHF)” regulation was September 2016. The regulation mandates a written food safety program that requires a risk-based hazard analysis incorporating “preventive controls” and development of a supply chain management program. Also, this regulation mandates radiological hazards be considered. The preventive controls program is to be supported by compliance with updated Good Manufacturing Practices (GMPs) found in 21 CFR 117, Subpart B. We will call this “Written Food Safety Plan #1”.

Starting in 2008, many larger dairy companies rebuilt their written food safety programs to comply with the requirements found in one of the Global Food Safety Initiative’s (GFSI’s) recognized third-party food safety certification schemes such as Safe Quality Foods (SQF), the British Retail Consortium (BRC), FSSC 22000 and the International Featured Standard (IFS). While the four GFSI schemes have differences, they all require a written food safety program that utilizes prerequisite programs to support the written HACCP Plan. The hazard analysis part of the HACCP Plan is supposed to incorporate “risk” into the decision-making process but does not require any recognition of potential radiological hazards. The GFSI schemes utilize specific prerequisite programs instead of GMPs to receive their certification. We can designate this as “Written Food Safety Plan #2”.

In May 2017, the U.S.-based National Conference on Interstate Milk Shipments (NCIMS) adopted the most significant changes for Grade “A” dairy plants since the early 1990s. These changes are likely to be accepted by the FDA in October 2017 and enforced in all “Grade A” dairy plants by October 2018. The new requirements will require a FSMA “Preventive Controls-like” written food safety program that will be evaluated by trained FDA Regional Milk Specialists once every three years, in addition to the routine GMP-like state inspections required once every three months. These NCIMS changes are similar, but not the same as required in the FSMA Preventive Controls regulation, with the FDA GMP requirements being somewhat superseded by the NCIMS Pasteurized Milk Ordinance (PMO) dairy plant operational requirements. In addition, the Preventive Control supply chain management requirements were modified to recognize the NCIMS strict requirements for utilizing only raw milk from Grade “A” licensed or permitted dairy farms and dairy ingredients from Grade “A” dairy plants. We recognize this as “Written Food Safety Plan #3”.

Finally, many large dairy companies have mandated policies and procedures on the content and details for a dairy plant’s written food safety plan. These mandated policies and procedures are “enforced” via corporate-based or private auditing companies hired to conduct plant-by-plant assessments. We can call this “Written Food Safety Plan #4”.

The problems related to multiple and possibly competing written food safety programs in dairy plants are significant. First, most dairy plants are challenged, like any food processing plant, with managing one written food safety plan. So how does a plant maintain and implement multiple written food safety programs? Second, how does plant management decide on the instructions and training for the plant staff that are responsible for delivering a safe finished product, based on multiple written food safety plans? Third, most plants are resource-challenged to support one written food safety plan, so where do the resources come from to maintain, implement and train staff on multiple written food safety plans?

A “revolutionary” process is required for a dairy plant with up to four different food safety programs to consolidate into one which contains the key requirements in one written food safety plan. This consolidated plan needs to use hybridization techniques to achieve a “Best in Class” food safety program. Such hybridization in nature many times produces much stronger off-spring with unique and new abilities to meet the challenges of the real world. This is the expectation for the “hybridized”, consolidated written food safety plan that will replace the multiples.

In conclusion, dairy plants need to conduct a hybridization exercise to move toward one “Best in Class” written food safety program that meets or exceeds government, private certification, customer and internal corporate requirements.

With more than 150 independent consultants, EAS has the expertise to assist any dairy plant or company in developing a “Best in Class” hybridized written food safety program. For more information, please contact Allen Sayler, EAS Senior Director of Food and Cosmetic Consulting Services at 571-447-5509 or via email at asayler@easconsultinggroup.com.