Changes are coming to pharmaceutical and food standards

Several medical-gas-related initiatives have quietly been gathering momentum over recent months. They include: Global harmonization of pharmaceutical standards and an update of the FDA cGMP (Current Good Manufacturing Practice) for food and food ingredient manufacturing. This article examines recent events related to these two initiatives, as well as their potential impacts in our industry.

Outside of putting the bubbles in soft drinks, most people are unaware of the extensive use of gases throughout the food industry—from the freezing and chilling of meat, poultry, fruit, and vegetables, to the gas packing of snack foods. Gases touch almost all aspects of the modern food industry at some point of the supply chain, and changes in cGMP requirements could have a significant impact on the gases industry.

The FDA and Food 

It should come as no surprise that FDA is looking to update the cGMP requirements related to food and food ingredients. In a recent announcement of a proposed survey of manufacturers, the agency believes: It is necessary to revisit and modernize the food cGMP’s since these practices were last revised in 1986 and there have been significant changes in food production technology, as well as important advances in the understanding of food-borne illnesses.

The agency also admitted that it lacks an adequate understanding of current manufacturing practices that would serve as part of a regulatory impact analysis. FDA plans to conduct an Internet survey of all domestic FDA-registered facilities that primarily manufacture or process food. The survey will also re-visit all foreign FDA registered facilities that primarily manufacture or process food.

Countries that fall within this survey include facilities that are located in those countries that are the largest food exporters to the United States: Japan, Canada, China, France, Italy, and Mexico. This activity, which is the first step in the FDA process to revise the cGMP requirements, will likely kick off in late 2007 or early 2008. At the same time, FDA is proposing to revise how the food cGMP’s are regulated and enforced.

The food safety regulatory system in the United States is a tiered system that involves federal, state, and (in some cases) local governments. The FDA is responsible for ensuring that all foods transported in interstate commerce, except those under the jurisdiction of the United States Department of Agriculture, are safe, wholesome, and labeled properly.

The role of the state agencies is to conduct site inspections and other regulatory activities that help ensure that safe food is produced, processed, or sold within their jurisdictions. Many state agencies also conduct food plant inspections under contract with the FDA.

The system FDA is proposing will allow these inspections to be performed under the individual state’s laws and authorities, the provisions of the Federal Food, Drug, and Cosmetic Act, or in some states both sets of requirements.

The Succinct Role of FDA

In essence, FDA’s role is to establish a uniform minimum set of standards for food safety, and purity. Where states have parallel requirements in the form of state laws, FDA appears to accept those requirements. Thus, it permits states to regulate and enforce those state requirements, rather than having them follow the Federal Food, Drug, and Cosmetic (FD&C) Act. Where individual state requirements surpass the Federal requirements, food and food ingredient manufacturing companies in those states would also be required to meet those additional requirements, which are above and beyond the minimum Federal standard.

FDA’s recent proposals will permit individual states to conduct site inspections, take samples, and perform analytical analyses. These state-run site inspection programs also include provisions for the individual states to establish recall programs, respond to consumer complaints, resolve industry complaints about the inspection program, and establish record keeping systems related to inspections.

State’s will still have to share all information with FDA, and although a state may have an inspection program approved by FDA, this does not preclude FDA from also conducting inspections in that state.

The exact provisions of the state / FDA partnership for regulating and enforcing food cGMP requirements was outlined in a July 2006 draft document produced by FDA entitled, Manufactured Food Regulatory Program Standards

The comment period for this draft document ended January 17, 2007, and to date, FDA has not issued any follow-on or final documents on this topic. Agreement With European Food Safety Authority In a further development, in July of 2007, FDA signed an agreement with the European Food Safety Authority (EFSA) that addresses the area of food safety risk.

This agreement is focused on facilitating the sharing of confidential scientific and other information, such as methodologies, to ensure that food is safe. This agreement is the first of its kind, and clearly communicates an increasing FDA interest in food safety, and a recognition that in today’s economy an effective program to assure food safety needs to be managed globally.

Wither New Regulations? We Give Them Our Take!

It is too early in the regulatory development process for FDA to even suggest what changes, if any, that body may be contemplating or how their actions will affect food gas cGMP requirements. However, our industry has already put forward its thinking on the appropriate controls and practices for food gas manufacturing.

In December of 2006, CGA issued the Publication M-10, entitled Guide to Food Gas Regulations and Industry Practices. This document outlines the latest industry consensus, within the processes areas and practices firms, about the practices that should be observed during the manufacture of food grade gases.

Documentation Will Be Key

In our opinion, ultimately, the food cGMP requirements will closely resemble most of the requirements the industry currently complies with in the manufacture of medical gases. The most significant change many firms will face is likely to be upgraded documentation requirements. As with medical gases, this documentation will not focus on the product quality of the gases themselves that distinguish and identify a food grade from an industrial grade gas.

The key distinguishing factor (between food gases and the corresponding gas in an industrial grade) will be the paperwork pedigree that accompanies the food grade product.

Another area, which is slowly and quietly gaining momentum, focuses on efforts by both the gases industry and FDA to globally harmonize standards, and ultimately, the compliance requirements between the U.S. and Europe / Asia. While medical gases made in the U.S. generally are not shipped outside the country (with the exception of some distribution to Canada, Mexico, and the Caribbean), most traditional pharmaceuticals are more global in their manufacturing and distribution of products. FDA is seeking to be more participative in the development and recognition of consensus standards, such as ISO.

To this end, FDA adopted a new staff guidance manual in March of 2007. The purpose of this manual is to establish agency-wide policies and procedures related to standards management, and ensure a unified approach to developing and recognizing standards within FDA. This appears to mark a shift in historical agency thinking. Traditionally the FDA has been highly reluctant to recognize or reference consensus standards outside of USP / NF and NFPA 99 standards. FDA has significant influence over both. Harmonization Between the Gases Industry and FDA Over the last decade, the GAWDA / CGA coalition has (unsuccessfully) approached FDA a number of times, in an attempt to have them recognize the CGA standards related to medical gases.

This new approach, hopefully, portends FDA’s becoming increasingly receptive to engaging our industry in a dialogue that will lead to realistic, manageable, and effective compliance requirements.

The gases industry has begun the process of closer cooperation of consensus standard activities related to medical gases. During the last 10 years, there has been a tradition of informal cooperation, regarding medical standards, between CGA and European Industrial Gases Association (EIGA). These two bodies have now decided to initiate joint meetings to discuss on-going initiatives and opportunities, and to cooperate more closely.

While any harmonization process is a slow and difficult road to travel, having joint European and U.S. agreement on medical compliance standards will ultimately strengthen and support any further efforts to have FDA recognize our industry’s consensus standards.

To most independent manufacturers of medical gases, these harmonization activities will likely appear to be of little interest. However, most of the rest of the world does not have a strong community of independent gas manufacturer as we have in the U.S. In fact, most of the cylinder business outside the U.S. is run by one major gas company. It is possible that, inadvertently, a provision or requirement could be subtracted or added that would unnecessarily limit the operational flexibility of the independent producers.

The harmonization process needs to be conducted in a manner in which all viable options are preserved, while achieving both compliance with regulations and harmonization of standards. To be effective this requires relevant and timely commitment from GAWDA and its members to the process, and is a key reason B&R, as the GAWDA Medical Gases Consultant, will be directly involved in on-going harmonization activities, providing the viewpoint of the independent manufacturers.

For more information on regulations that affect medical gas producers and end-users contact Ron Ball at B&R Compliance Associates LLC (317) 297-8518; e-mail: ron.ball@brcompliance.com or visit B&R on the web at www.brcompliance. com

Specialty Gas Report THIRD QUARTER 2007 //