September 1, 2015

Training Management Best Practices for Emerging Life Science Companies

Jeff Mazik

Jeff Mazik, Vice President, Life Science Solutions, AssurX

No matter how good your written policies are, or how clean a facility you operate, or how successful you are in the marketplace, it can all fall apart without a strong handle on your organization’s training needs and ability to effectively manage a training program. Ensuring that your staff is properly trained to do their work is a basic expectation for regulatory bodies in the life science industries. In order to manage this extremely important activity, your organization must:

  • Properly identify and maintain training requirements
  • Manage all associated training activities
  • Identify, provide, and manage training materials and locales
  • Be able to successfully report on an individual’s training history
  • Ensure outstanding training needs are being completed in a timely manner
  • Ensure training is effective

Implementing a best practice solution for training management is essential to help an emerging life science company ensure compliance and quality. Regulatory agencies in the life science industries demand that your company has proper controls in place that ensure your staff, employees and non-employees are properly trained, that their training is documented, and that changes that require re-training are properly maintained, communicated, and rolled out, resulting in auditable documented training.

trainingblogUtilizing an electronic training management system is preferable, but regardless of the system, there are a few things one must begin to compile to be ready to implement a structure that helps a training organization or human resource staff successfully manage training. Another important goal here is the ability to create an environment where a change to a training requirement results in an immediate and logical set of training tasks to be assigned to affected trainees. This is essential in ensuring ongoing quality within your organization’s training environment.

So how does one begin creating such an environment? The first step is understanding your own organization’s training landscape. Your organization has a number of people, each may play multiple roles (this is especially true with start-ups), and, as such, each role has its own training needs and requirements. Also contained in this landscape are many training elements that need to be managed. These include documents and courses that might be required. You will need to gather this information and get it into a structure that allows the easiest management as changes occur. Also, it is imperative that you have a good idea of how changes will be handled as they will inevitably occur and also to identify how these changes will be communicated.

Once you have a good understanding of your current landscape, the next step is to follow a four step process to identify and structure the data so as to be ready to manage the training for your organization. Let’s take a look at each step:

  1. Requirement Building. The goal of this step is to identify and document all training elements (documents and courses) that are required to achieve a specific requirement (e.g. Manager Requirements, Sterile Cleaning requirements, General Human Resource requirements, etc.)
  2. Role Identification. The goal of this step is to identify the roles/major activities that are present in your organization (e.g. Shift Manager, Line Operator, Employee, etc.)
  3. Role-to-Requirement association. The goal here is to take the defined requirements, and assign them to the Roles identified. Note that some roles have multiple requirements to complete. For example: the “Shift Manager” may have both the “Sterile Cleaning” requirement and “Manager” requirements assigned to him/her
  4. Identify employee’s role(s). The goal here is to assign the identified role (or roles) to the individuals, showing which roles they perform for our company. (For example, John Smith serves in the “Shift Manager” and “Employee”)

When completely implemented, if a new training document (for example) is added to a requirement, all employees whose role incorporates that requirement will now be required to be trained. Or if a person changes roles within an organization, the act of assigning that role to that person will trigger the need for new training and assign it to that person.

This four step approach provides you with a very powerful way to manage training in your organization. It helps you organize training by roles for an employee or contractor, but it also helps you organize requirements for those roles. In effect, you are now able to manage your complete employee and contractor training in a grouped fashion.

Importance of Automation:

At first glance, to manually manage these lists in a spreadsheet or other common office tool can be very overwhelming. That is where implementing a training management solution, configured to handle training management particularly, helps out tremendously. Advantages of using a training management solution include:

  1. Immediate email notification whenever new training is required (triggered by adding or changing of roles, requirements, courses, or documents)
  2. Ensure timely staff training (due dates tracked and charted, reminders sent)
  3. Ensures appropriateness of staff training (only those affected get training notification)
  4. Easily manage changing training requirements
  5. Quickly identify “who-needs-what” training
  6. Easily identify outstanding delinquent Training and escalate to management, if necessary

Plus, there are many advantages if the training management system is integrated within the company’s document management system. Examples include:

  1. Automatic training notifications generated as a document revision becomes available for training
  2. Overall paper reduction
  3. Ensures user is accessing and training on the current version of the document
  4. Training documents can be provided online via a “click” (potentially minimizes users need to hide old versions of documents)

Bottom line: if implemented accordingly, using this four step approach within a best practice training management system results in an environment where people are trained to do the job they have been hired to do.

Note on resources:

Many start-ups and emerging companies in the life science industries are constrained in a number of ways — notably in funds and resources. This can present many hurdles in trying to get a useful training management system in place. In order to minimize costs and expending copious resources, some options to consider include: selecting a solution that can effectively address multiple business or quality needs to increase ROI, a solution that provides a lower cost option of hosting off-site (e.g., cloud-based solution), one that utilizes non-proprietary infrastructures, and one that can be configured without requiring programming resources.

Other items to be aware of:

A best practice approach for implementing an electronic training management system also includes these other important attributes. They are true needs that best of breed quality management systems will provide:

Communication: Automatic assignment of training when requirements change and then communicates those assignments effectively.   Notification to users of coming-due uncompleted training tasks, and course registrations.

Client experience: The electronic system should incorporate end-user functionality that increases performance and acceptance such as: including built-in instructions within the process itself as well as visual hints or cues that make it obvious to the user where the document is in the process and what to do next. Also, it’s preferable to use dashboards displaying only data pertinent to the user.

Control: As with any validated system, changes to the process need to be controlled and managed under change control procedures. Also, control of business processes is key. The system should provide seamless integration and flow to other quality and/or business processes, such as to document management, or to provide CAPA generated re-training tasks.

Compliance: The electronic system must meet all applicable regulatory requirements (e.g. 21 CFR Part 11). Also, implementing reminders and escalations when tasks are due (or late!) helps you to stay in compliance to objectives and agreed upon timelines.

Configurability: The solution you use should be easily configured, maintained, and updated, breaking you from a strong reliance on costly programmers, consultants, and specialized IT resources to make a change or to add a step to the process.

The above is a summary of a Webinar conducted recently titled “Training Management Best Practices for Emerging Life Science Companies”. If you are interested in getting more details Training Management Best Practices and to view a demonstration of a Web-based solution that meets these best practice elements, please request a replay of the 60-minute Webinar here.

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Quality Takes Time, FDA’s CDER Reminds Drug Makers

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Scholars still debate how long it took to build the Great Wall of China, but it’s generally agreed it was built in stages between the Fifth Century B.C. and the Sixteenth Century A.D.. The Great Pyramid of Giza took about twenty years to construct, according to ancient historians, but it must be remembered that Egypt’s rulers were pretty rough on their non-volunteer workforce. Deadlines had a deeper meaning back then.

By contrast, the Center for Drug Evaluation and Research (CDER) quality initiative has been with us some ten years, or about the time it took to build the Panama Canal. Both projects have had to dig through – and around – a lot of muck. At the peak of work, excavators in Panama carved out the equivalent of the English Channel Tunnel every 14 weeks. It’s not fair to hold the agency to that same standard.

Pharmaceutical manufacturingInstead, let’s acknowledge that FDA just completed its own new structure called the Office of Pharmaceutical Quality (OPQ). Less bricks and mortar than a shift in human capital, the OPQ will take on some of the functions and staff at the Office of Pharmaceutical Science (OPS), take some preapproval and surveillance inspections duties from the Office of Compliance (OC), and absorb some of the inspection-related activities for bioequivalence/bioavailability and non-clinical studies from OC’s Office of Scientific Investigations. The idea is to make the drug review more integrated with FDA and improve communications both ways.

The agency hopes OPQ will streamline the processes that monitor drug quality throughout the product lifecycle, including drug application review, post-approval improvements, and surveillance and inspections of global manufacturing facilities.

OPQ was built, in part, in response to the falling number of drug-related product recalls over the past few years. FDA believes OPQ will help it better organize and quantify the state of manufacturing at drug facilities in the US and abroad. FDA’s recently been pushing a new approach to quality metrics, as highlighted by CDER’s Russell Wesdyk. His presentation outlines CDER’s revised way of looking at surveillance and adoption of quality metrics that promote the use of a common language to improve measurement.

According to Wesdyk, quality metrics will be used to assist segment sites and producers based on risk when it comes to inspection and reviews. But it won’t issue “restaurant style grades” reporting how one facility stacks up against industry groupings. Wesdyk encourages any interested parties to reach out to him as FDA’s thinking evolves. That’s a good thing.

Remember, it’s not as if the Panama Canal doesn’t require some maintenance now and then. The FDA’s got the right idea here.

The alternative is to build something and then forget about it. We’ve all seen how that usually turns out.  Take a look at the Pyramid of Giza lately?

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FDA’s CDER Unveils Ambitious 2015 Wish List

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

The holidays came a little early for the folks at the Center for Drug Evaluation and Research (CDER). They just released their sometimes optimistic, but always enlightening guidance wish list and overall priorities for 2015. Let’s take a look.

CDER Director Janet Woodcock recently said these are her agencies “front burner” priorities:

  • Implementing and clarifying statutory provisions on drug compounding.
  • Meeting Generic Drug User Fee Amendments (GDUFA) review goals that went into effect Oct. 1 last year.
  • Continue the build out of Office of Generic Drugs “super office.”
  • Build out the Office of Pharmaceutical Quality.
  • Implement and continue to develop Program Alignment Group agreements with the Office of Regulatory Affairs.

She singled out the implementation of a new process, data and document management IT system as a “big deal” goal this year

But there’s plenty more on FDA’s big front burner:

  • Respond as needed and participate in “21st Century Cures” legislative activities.
  • Rapidly re-evaluate regulation of drug advertising and promotion.
  • Execute immediate actions required by the Sunscreen Innovation Act and implement a longer-term plan.
  • Respond to Ebola outbreak.
  • Issue final guidances on abuse-deterrent opioid formulations.

She’s also hoping to fill more than 600 staff vacancies and recruit for a slew of executive positions.

prescription drugsWoodcock’s ambitious goals include five more bulleted pages of additional “important” priorities ranging from implementing a biosimiliars program, working on the Drug Label Improvement Initiative and developing a strategic plan for managing a growing pile of drug imports.

In the agency’s spare time, the plan is to issue nearly fifty guidances in advertising, biopharmaceuticals, biosimiliars, clinical medical/pharmacology/statistical/drug safety, electronic submissions, generics, and labeling, among others. Each of these guidances are already under development, CDER said earlier this month.

It’s certainly important to have goals, and a person’s reach should exceed their grasp, etc, but there’s also the problem of over-promising and under-delivering.

FDA’s got a big front burner but maybe not enough cooks, or oven space, to get it all done in 2015. We’ll keep an eye on it and report back throughout the year. Bon appetit.

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Got Safe Beef? New Report Suggests the US Doesn’t

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

The next time you want a cheeseburger, you might consider hopping a plane and flying to Germany. Or France. Or New Zealand. Basically, anywhere but the United States of America.

Almost across the board, the US ranks at the bottom (“regressive”) for produce traceability programs as ranked by a new Institute of Food Technologists (IFT) report.

IFT checked out 21 countries and rated them “Progressive,” “Moderate,” or “Regressive” based on a handful of criteria.

While the landmark Food Safety Modernization Act of 2010 (FSMA) is expected to improve things here in America, “development of regulations are still in the early stages,” the study noted. Technically, the study is called “Comparison of Global Food Traceability Regulations and Requirements.” That’s quite a mouthful, pun intended. An earlier IFT powerpoint presentation also examined this important issue.

FSMA was signed into law by President Obama on January 4, 2011. FSMA was designed to give the Food and Drug Administration (FDA) new power to regulate the way foods are grown, harvested and processed. The law grants FDA a number of new tools, the most important of which is mandatory recall authority. But that’s all in the future. The IFT report tells us what’s going on right now.

Where to start when reading the report? The ranking of 21 countries (EU, China, Japan and a few elsewhere including Brazil and the land of the Kiwis) found that the US was only one of two major beef exporters without mandatory red-meat traceability systems. It also lagged behind most of the group with a weak consumer access program.

Generally, countries in the EU (France, UK, Germany, Ireland et al) led the group. That’s thanks, in part, to tough standards imposed in 2005 that include mandatory traceability programs for food, feed, food-producing animals and any other substance incorporated into food or feed.

livestockBlog

The US did achieve some distinctions — pretty much all bad. For example, it joined China as the only countries rated regressive when it comes to the breadth of products regulatory traceability regulations.

The US, China and Canada are also the only members of another not-so-attractive-club: Regressive electronic livestock traceability programs.

In its summary, the report diplomatically notes the obvious: The US “trails most other nations.”

Let’s wrap this up on something of a positive note.The US did make the top category for voluntary traceability programs. An optimist might say US meat exporters are significantly exceeding their nation’s relatively lax regulatory requirements. Pessimists might still urge you to think twice before buying that next cheeseburger, chicken sandwich, or tilapia in America — at least until the FSMA kicks in.

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FDA FastStats: A Look Back at 2013 Medical Device Warning Letters with Quality System Deficiencies

In our latest infographic analysis, today’s post highlights medical device warning letters with quality system deficiencies. Surprisingly, warning letters were actually down 12.2% from 2012. However, they are almost double the number (77) issued in 2009. Are we looking at a downward trend? The jury’s still out. The highest number of warning letters issued in the past 10 years was in 2012, with a total of 164. The lowest was 2007, with only 74 warning letters issued.

FDA FastStats 2013 - Warning Letters

 

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FDA FastStats: A Look Back at 2013 Medical Device 483 Observations

As we approach the end of 2014, we will take a look back at FDA’s stats on various topics sourced from their Case for Quality initiative. The FDA believes that the following type of information will:

  • Help industry improve medical device quality by sharing common observations
  • Identify possible areas of emerging concern, and
  • Possibly help firms avoid warning letters

Our first in the series of infographics is 483 inspectional observations.

FDAFastStats2013cr

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FDA’s Local Offices Flex Regulatory Muscle

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

In our latest round-up, it was the District Offices turn to chime in on medical device company alleged shortcomings.

As expected, FDA is shifting more and more of its regulatory focus toward Medical Device Reporting (MDR). In an October 1 letter, the agency’s Baltimore District Office hit Baltimore-based Electronic Development Labs for not having an MDR procedure. Bad idea.

The company may not have recovered very well, either. “The adequacy of your firm’s response dated November 20, 2013, cannot be determined at this time,” FDA’s warning letter said. “Your firm’s response indicates that the development of an MDR procedure was added to a list of action items. In order to determine adequacy, FDA must receive a copy of the MDR procedure for review.” Electronic Develop makes the NervoScope.

The agency also gently encouraged the company to look into eMDR.

As we’ve noted before, FDA eMDR Final Rule requiring manufactures and importers to submit electronic Medical Device Reports (eMDRs) to FDA was published on February 13, 2014. The requirements of this final rule will take effect on August 14, 2015. If a firm is not currently submitting reports electronically, FDA politely encourages it look into it on FDA’s web page devoted to eMDR.

The FDA demonstrated its ongoing interest in CAPA in an October 7 letter from its Los Angeles Office to Alpha Medical, a maker of angiographic balloon catheters.

warning640After Alpha tried to respond to a September inspection, FDA made it clear the reply needed some work. Example: “CAPA 104 was opened on January 10, 2013, concerning non-conformities regarding balloon extension air leaks. The CAPA report references multiple root causes for these leaks; however not all of these potential causes were analyzed and investigated.”

The agency went on, “Your records reference that personnel were retrained, but the corrective actions for which they were retrained were not documented. Additionally, this CAPA was closed on February 22, 2013 without documentation that an effectiveness check was performed.

In an October 10 letter from the Cincinnati District Office, local regulators challenged West Lake Enterprises, maker of medical gas pressure regulators and suction regulators, with CAPA and other violations, including installation that’s not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation. The company responded, and FDA came back with additional questions.

The Denver District Office joined in with an October 28 letter to Xanacare Technologies, maker of SimulCare II, a therapeutic lamp/nerve stimulator/massager. The agency hit them for several issues, including problematic design control, device history records (DHR) and complaint handling. As of late October, the agency said it had not received a response from Xanacare.

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Are You Ready for 21st Century eMDR Submissions?

Jeff Mazik

Jeff Mazik, Vice President, Life Science Solutions, AssurX

If you have been procrastinating on setting up electronic submissions for your adverse event reports to the FDA, you might want to reconsider that decision. Earlier this year, the FDA published its final rule on MedWatch/eMDR reporting. Although not much has changed in this final rule in regard either to required content, the submission process, or submission timelines, the FDA has taken a large step closer to mandating 21st century technology. The final rule states that all required adverse events are to be submitted electronically by August 14, 2015.   The clock continues to tick…

Not sure if you’re handling this new reality properly? Well, here’s a quick way to find out.

Are you (or your management) making any of these statements:

“The FDA always delays, we will just wait and see.”

FDA has shown no indications of changing or extending this electronic submission requirement timeline. Their hardline stance is mostly due to the fact that electronic submissions of the MedWatch form via electronic means (through their ESG) has been available for many years on a voluntary basis. Numerous manufacturers have taken advantage of this technology over the last number of years to streamline adverse event reporting. Soon, the electronic submission process for these reports becomes mandatory.

We don’t submit a lot of complaints, we will just wait until we have something to report.”

Maybe your company does not have many adverse events to report…maybe only once in a blue moon (great for you!). However, if you wait until a complaint occurs (after August 14, 2015), and the complaint results in a reportable event that requires submission, you are caught in a very dangerous game of Russian roulette. You see, an electronic account is required to be set up prior to an eMDR submission. FDA has previously stated that the setup of an account takes between two-to-six weeks (not counting the form completion process and ensuring all was filled out correctly). Now, depending on the adverse event, you will have between five to 30 days to officially submit it to the FDA, electronically. With a two to six-week wait on an account, you will be caught in a waiting game that in all likelihood will make you non-compliant. That’s not a good place to be.

Don’t get caught in this game where you are most likely going to lose. There are options available to do this submission electronically in a secure, managed, workflow driven environment.

“Ok, Im convinced, what options do I have for submitting electronically?”

If you already submit your adverse events to the FDA electronically, there is nothing you need to change. However, if you do not and are still submitting via paper/PDF, now is the time to start investigating your options. Although the FDA provides the eSubmitter tool to help you submit the reports electronically, it does not integrate with your electronic quality management system, provide electronic signature approvals, a workflow process, KPI measurements, or the like. In many cases users will be required to re-key or copy/paste data from their original source. This error prone, non-integrated solution leaves much to be desired, but it does serve as a quick and easy way to submit the completed report.

eMDR

AssurX eMDR Process

A better, more integrated business model is available, however. AssurX, a leading EQMS provider, has for many years offered a low cost standalone eMDR electronic submission solution. Furthermore, it can optionally be fully integrated into a complaints management workflow solution for your business, providing electronic reviews and approvals, tracking tasks, generating email notification and escalations, as well as identifying trends and tracking key performance indicators for your business. Either of these AssurX solutions can be implemented on premise, or in a privately hosted “cloud” solution that allows you to implement more quickly and with lower start-up costs.

It’s time. Get started now.

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FDA Warning Letter Analysis: CAPA, CAPA, and More CAPA!

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

After a flurry of activity, it’s been relatively quiet of late on the FDA warning letter front. But three device makers did get some bad news in recent weeks.

FDA’s Philadelphia office hit Pittsburgh-based Zoll Manufacturing Corporation, a make of Class III medical device Life Vest with a number of observations, including failure to document a corrective and preventative action program (CAPA), review, evaluate, and investigate complaints, adequately establish procedures for design validation, and develop, maintain, and implement electronic Medical Device Reports (eMDRs) to the agency.

The eMDR Final Rule requiring manufacturers and importers to submit eMDRs was published February 13, 2014. The requirements of this final rule will take effect August 14, 2015.

Zoll’s senior management was also singled out in the September 23 warning letter for being unable to provide records of adequate attendance at management review meetings in 2013 and this year.

Our west, FDA hit Mission Viejo CA-based Alpha Medical Instruments for CAPA and other violations. Alpha manufactures angiographic balloon catheters.

Corrective/Preventive Action Workflow  as illustrated by AssurXDigging deeper into Alpha’s alleged CAPA problems, FDA’s October 7 letter noted that the firm closed out an investigation without being able to produce documents proving it had conducted an effectiveness check. Additional product problems emerged after the CAPA was closed out. Alpha’s subsequent response was found wanting by the agency.

Alpha was also dinged for failure to establish procedures for reviewing, receiving and evaluating compliance by a formerly designated unit, among other issues.

It’s worth noting that, while industry sometimes complains that FDA inspectors are inconsistent in terms of focus and expectations, it’s pretty hard to say FDA isn’t sticking with its emphasis on CAPA issues.

Finally, FDA identified problems of a different sort at Powers Device Technologies Inc., a Del Ray FL-based manufacturer of the Pacifier Activated Lullaby. The firm was charged in a September 25 warning letter with making unapproved product modifications and marketing those supposed new benefits without agency review. It’s been marketing the product as FDA-approved when, in fact, the agency said it has not approved the product as now constituted. The company must respond later this month in writing to the FDA to address these and other observations.

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FDA Proposals Take a Fresh Look at Some Stale Food Issues

Tamar June

Tamar June, VP, Strategic Marketing, AssurX, Inc.

That landmark Food Safety Modernization Act (FSMA) just keeps getting more and more important. Earlier this month, the FDA unveiled four proposed amendments that will likely make a tough law even tougher.

FSMA, signed into law in January 2011, is designed to tighten food safety regulations and shift the focus to a proactive mindset and away from FDA’s relatively reactive approach in years past. FDA has now proposed seven rules to implement FSMA. This new wave of proposed revisions target four areas: produce-safety; preventive controls for human food; preventive controls for animal food; and the foreign supplier verification program.

The action follows FDA’s May announcement it was engaging in the rule-making and guidance development process required to establish the new prevention-oriented standards. FDA implementation teams have developed a slew of ideas for how the agency can better oversee the food industry, strengthen the global food safety system, and enhance protection of public health. Planning has also begun for the next phase of FSMA implementation, which involves advancing new public health prevention standards and implementing the strategic and risk-based industry oversight framework at the heart of FSMA.

In just part of what could go into effect next year, FDA calls for revisions to the foreign-supplier verification proposed rule. It aims to give importers more flexibility to determine appropriate supplier verification measures based on risk and previous experience with their suppliers.

Arguably, one of the more important FDA proposals is a new call to develop current Good Manufacturing Practices (cGMPs) more applicable to the animal food industry, provide flexibility for a wider diversity in the types of animal food facilities, and establish standards for producing safe animal food.

foodsafety570However, human food processors already complying with FDA human food safety requirements, such as brewers, would not need to implement additional preventive controls or cGMP regulations when supplying a by-product (e.g., wet spent grains, fruit or vegetable peels, liquid whey) for animal food, except for proposed cGMPs to prevent physical and chemical contamination when holding and distributing the by-product (e.g., ensuring the by-product isn’t co-mingled with garbage). That noted, further processing a by-product for use as animal food (e.g., drying, pelleting, heat treatment) would still require compliance with the preventive controls for animal food rule.

FDA’s new amendments would also make exemptions a bit clearer, and raise the requirements defining a “very small business.” To be considered tiny, a firm must post less than $2.5 million in total annual sales of animal food, adjusted for inflation. FDA expects that exemption to apply to just over 4,000 facilities.

The proposed rules also address some supplier issues. FDA wants new controls addressing those occasions when the receiving facility’s hazard analysis identifies a significant hazard for a raw material or ingredient, and that hazard is controlled before the facility receives the raw material or ingredient from a supplier.

If these new FDA proposals become the law of the land, the facility would have flexibility to determine the appropriate verification activity (such as onsite audit, sampling and testing, review of supplier’s records) unless there is reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals.

Industry and any other interested parties have some time to weigh in on the FDA’s proposals. The FDA will accept comments on the proposed revisions of the four proposed rules for 75 days starting next week (September 29) while continuing to review comments already received on the sections of the proposed rules that are going to change. The agency will consider all comments before issuing final rules sometime next year.

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