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FDA Inspectors Crave a Good Hot Cup of CAPA

February 9, 2012 By Leave a Comment

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

One of my favorite all-time bands, The Kinks, have a fantastic tongue-in-cheek song called “Have a Cuppa Tea” that satirizes the British belief that a good hot cup of tea will solve all of the world’s problems.

I think the FDA misread “Cuppa” and instead decided that if it focused on CAPA it, too, would solve all the of the [medical device] world’s problems.

An analysis of 2011 and 2010 FDA inspection observations in 483s shows clearly that CAPA remains at the top of the charts for the FDA (see charts below).  FDA’s own analysis of its 3,434 483 observations in 2010 found that CAPA was the number one, with a total of 1058 citations. Number for 2011 aren’t yet available, but there’s no indication they are going anywhere but up.

And that’s probably not going to change in 2012, either.

Why is CAPA so important? Melissa Torres, part of the Center for Devices and Radiological Health’s Quality System Team in the Office of Compliance, put it clearly. CAPA matters because it is “linked to so many other requirements.”

Consider this, CAPA touches on:
  • 820.198 Complaint files
  • 820.90 Nonconforming Product
  • 820.80 Acceptance Activities
  • 820.200 Servicing
  • 820.22 Audits
  • 803 Medical Device Reporting (MDR)
  • 806 Reports of Corrections and Recalls…
“…and many more,” Torres emphasizes. Plus, dealing with CAPA effectively helps FDA inspectors relax because they get the sense you have detected and resolved any significant problems.

On the flip side, if you don’t have CAPA in control, you’re going to need a lot stiffer drink than a cup of tea.

The top 10 observations for 2011 were:
  • 21 CFR 820.100(a) – Procedures for Corrective and Preventative Action (CAPA) have not been adequately established;
  • 21 CFR 803.17 – Written Medical Device Report (MDR) procedures have not been developed/maintained/implemented;
  • 21 CFR 820.198(a) – Complaint handling procedures for receiving/reviewing/evaluating  complaints have not been established/defined/documented/completed/implemented;
  • 21 CFR 820.100(b) – Corrective and Preventative Action activities and/or results have not been adequately documented;
  • 21 CFR 820.75(a) – A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures;
  • 21 CFR 820.22 – Quality audits/reaudits have not been performed;
  • 21 CFR 820.22 – Procedures for quality audits have not been adequately established;
  • 21 CFR 820.30(a) – Procedures for design control have not been established;
  • 21 CFR 820.30(i) – Procedures for design change have not been adequately established;
  • 21 CFR 820.20 – Management with executive responsibility has not ensured that an adequate and effective quality system has been fully implemented and maintained at all levels of the organization.

The top 10 observations for 2010 were:

  • 21 CFR 803.17 – Written Medical Device Report (MDR) procedures have not been developed/maintained/implemented;
  • 21 CFR 820.100(a) – Procedures for corrective and preventive action have not been adequately established;
  • 21 CFR 820.100(b) – Corrective and preventive action activities and/or results have not been adequately documented;
  • 21 CFR 820.75(a) – A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures;
  • 21 CFR 820.198(a) – Complaint handling procedures for receiving/reviewing/evaluating  complaints have not been established/defined/documented/completed/implemented;
  • 21 CFR 820.50 – Purchasing controls,. Lack of or inadequate procedures Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established;
  • 21 CFR 820.198(a) – Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established;
  • 21 CFR 820.198(c) – Complaints involving the possible failure of a device/labeling/packaging to meet any of its specifications were not reviewed/evaluated/investigated where necessary;
  • 21 CFR 820.22 – Procedures for quality audits have not been adequately established;
  • (tie) 21 CFR 820.22 – Conducted quality audits/reaudits have not been performed;
  • (tie) 21 CFR 820.30(i) – Design changes – lack of, or inadequate procedures.
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CDRH 2012 Strategic Priorities Emphasize QA, Life Cycle Management

February 1, 2012 By Leave a Comment

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Deciphering the FDA is a bit like trying to understand what the old USSR was up to in the days of the Cold War.  In those days, it was called Kremlinology, or the study of a complex, secretive organization.  We need a catchphrase for those of us today who try to figure out what the FDA means when it says something, or what it means when it says nothing, or what it means when it tells you what it means. You get the idea.

The FDA has been talking a lot of late about transparency. Its 2011 initiative is an agency attempt, it says, to open up about how it does business. FDA is accepting comments on it until February 28.  The jury is still out on whether this initiative will accomplish much.

Our latest piece of FDA evidence is CDRH’s 2012 Strategic Priorities.

CDRH devotes the Introduction of the document about looking ahead to patting itself on the back for its 2011 achievements, e.g. its report, “Understanding Barriers to Medical Device Quality,” that reviews the challenges that the FDA and industry face in supporting well‐integrated, best‐quality manufacturing practices and strategies that industry and the FDA can take to overcome these barriers.

CDRH also reminds us that “to complete this work [in 2011] our staff went above and beyond their already demanding workload. This is a remarkable achievement.”

Good to know.

In 2012, CDRH says it will continue to emphasize four priority areas:

  1. Fully Implement a Total Product Life Cycle Approach
  2. Enhance Communication and Transparency
  3. Strengthen Its Workforce and Workplace
  4. Proactively Facilitate Innovation to Address Unmet Public Health Needs

CDRH promises in 2012 to “improve” its premarket programs. By April 1, it pledges to begin its Triage of Pre-market Submissions Pilot to “increase submission review efficiency and better manage the pre-market review workload.”

And by the end of the year, CDRH pledges to publish a proposed rule to clarify the circumstances under which it could rely on clinical studies conducted in and for other countries. CDRH also says it will finalize all guidance documents it has issued as part of its overall plan to improve its premarket programs.

We’ll keep an eye on these and other promises throughout the year and report back as FDA hits or misses its own targets.

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Filed Under: FDA Regulated, Featured, Medical Devices, Michael Causey, Quality Management, Regulatory, Risk Management Tagged With: , , , , ,

FDA Provides Important Clinical Trials Guidance

January 25, 2012 By Leave a Comment

Patrick Stone, President, TradeStone QA

In the age of electronic documents and electronic signatures, the FDA is still defining and providing guidance for 21 CFR Part 11 concepts it began in 2003.  It seems we all really need to catch up.

Now that FDA provides small business webinars and blogs about “the most pressing public health issues of the day”, it is refreshing to note that FDA does not deem all electronic records as regulated; however with human clinical trials, most if not all records are reviewable (investigator discretion).

Basic concepts like hybrid records (paper based, e-records) and meta-data (audit trail data-points) should be well defined by now and not mysterious to industry.  Enforcement discretion still applies for most Part 11 electronic review by FDA investigators.

The new risk based approach will need to be well documented and defined before approval is granted by the respective review division.  In 2007, FDA provided the most up to date guidance and current thinking on computer systems used in human clinical trials.

The three main concepts in this risk based approach are:
  1. Subject protection
  2. Human subject rights, and
  3. Data integrity.

Once you can establish and document these three risk based controls you are ready to begin your clinical trial. The risk based approach continues throughout all phases of your clinical trial.

For clinical trials the FDA designates three tiers of data:
  1. Data entry
  2. Data review (PI or monitor)
  3. Data processing including transfer to FDA for your application.

Companies conducting clinical trials in the all-electronic environment with e-patient source, e-case report forms, and scanned regulatory records may find that costs go down. You have spent multi-millions in assets to implement validated e-systems so now you may use “alternative monitoring” methods for your monitoring controls.

Human clinical trials can be monitored from a desk if your monitoring plan is deemed acceptable to the review division. You do not necessarily have to pay travel expenses for multi-site monitoring anymore. Here is the game changing draft guidance for “Oversight of Clinical Investigations  A Risk-Based Approach to Monitoring” and I have also included the link for the 2012 Small Business webinar “Electronic Source Documentation in Clinical Trials” here.

There’s more to this subject and we’ll revisit it again.

Patrick Stone is the author of Bubble Gum Badge – An FDA His-Story. You can also follow him on Twitter.
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Filed Under: Bloggers, FDA Regulated, Featured, Medical Devices, Patrick Stone, Pharma/Biotech, Regulatory Tagged With: , , , ,

Misguided FDA Food Regulations Will Hike Costs, Not Safety

January 23, 2012 By Leave a Comment
Julie Gunlock

Julie Gunlock, Senior Fellow, Independent Women's Forum

2012 will mark another year of aggressive food regulation at the FDA. On tap, salt regulations and industry-wide regulations dictating which foods can be advertised on television.

In October last year, the FDA announced in the Federal Register that it would begin accepting comments on “approaches to reducing sodium consumption.” The announcement cited 2005 medical studies’ findings that excess sodium consumption is a contributory factor in the development of hypertension. Yet studies conducted subsequent to that 2005 study came to different conclusions.

For instance, in 2006, the American Journal of Medicine published a study of 78 million Americans. It found that the more sodium people ate, the less likely they were to die from heart disease. In 2007, a study published in the European Journal of Epidemiology found no association between urinary sodium levels and the risk of coronary vascular disease or death.  Most recently, in 2011, researchers in the U.K. reviewed data from seven studies with over 6,200 participants who reduced their salt intake. The results showed that while eating less salt did lower blood pressure, it did not reduce the risk of dying or of having heart disease.

saltEven the relationship between salt and hypertension has been questioned. A recent study published in the science journal Nature suggests genetics, not diet, is the major contributor to hypertension. Another study in 2011 suggested that obesity, not salt, determines an individual’s blood pressure.  Clearly, the science is not settled on salt. Therefore, individuals – not government regulators – need to make decisions about their own diets.

The FDA’s call for regulation also suggests that the food industry isn’t responding to consumer demand for lower sodium food products.  This simply isn’t true.  From potato chips to tomato sauce, consumers can choose a variety of low-salt and even no-salt items.  In other words, the market is working to meet the health needs of the American consumer.

The FDA is also interested in regulating how the food industry advertises their food products.  Reducing childhood obesity is a top priority for the Obama Administration and regulating how food is marketed to children is one method the administration feels will accomplish this goal.

In the spring of 2011, an interagency working group made up of four powerful federal agencies (including the FDA) issued recommendations on what food products can be advertised on television during children’s programming.

Many viewed this regulation as unnecessary since food advertising during children’s programs has already declined 50 percent between 2004 and 2010.  In addition, 17 of the leading food companies (which represent more than three-quarters of the products advertised to children under twelve) have signed the Children’s Food and Beverage Advertising Initiative pledge to only advertise healthy foods.

Despite these voluntary efforts on the part of industry, the working group developed a set of extremely stringent “nutrition principles” under which a food must fit in order to be allowed to advertise.  Yet nearly every type of food a child might enjoy (even foods parents generally consider healthy) failed to meet these new guidelines.  Items like milk, cheese, crackers, yogurt, bottled water, and canned soups would have been banned from television advertising.

Responding to outcry from the food industry (and consumers), Congress included a provision in the Consolidated Appropriations Act of 2012 requiring the working group to conduct a cost-benefit analysis of their proposed regulations. While this news was met with some relief by the food industry, the FDA will still likely pursue some form of advertising regulations on food manufacturers in 2012.

Those advocating regulations on the food industry—on specific ingredients and marketing—believe these measures will result in healthier Americans.  Yet it is doubtful that they will impact anyone’s real food choices.  Instead they will hike food costs as companies work to satisfy government regulators by overhauling their products.

You can follow Julie on Twitter here.

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Filed Under: FDA Regulated, Featured, Food, Regulatory Tagged With: , , , ,

FDA Offers Salty Recipe for Increased Food Regulation in 2012

January 3, 2012 By Leave a Comment

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

To salt or not to salt? That is the question. Well, it’s one of the questions.

It’s actually bigger than a battle over a popular condiment, according to some folks who oppose what they say is the FDA overplaying its regulatory hand.

We’re not going to settle this controversy here, but some experts suggest you may be able to sprinkle a little salt on your food without feeling guilty about increasing your risk of heart disease and high blood pressure.

However, some say the FDA has gotten too activist and one-sided in its approach to the condiment – and that it’s just another sign that the FDA in 2012 will be more strident with regulatory overreach that won’t help food consumers and will harm food manufacturers.

saltThe FDA is generally following the lead of a 2010 report from the IOM that says salt contributes to serious health problems. The agency is working on a guidance now that would promote ways to reduce salt consumption by Americans in their diet.

“I think the FDA is adding unnecessary bureaucratic layers” that aren’t improving food safety and are in fact making it harder for food manufacturers to do business, says Julie Gunlock, a senior fellow at the Independent Women’s Forum, a non-partisan research and educational institution that seeks to combat what they say is the too-common presumption that women want and benefit from big government. In the case of salt, for example, Gunlock says the FDA is ignoring more recent studies that at least question the strong connection between salt and the health problems.

Gunlock has written extensively about what she calls “the damage” caused by intrusive FDA regulations. She focuses on the harm to food processors and manufacturers, and the role of parents in making dietary decisions on behalf of their children.

For Gunlock, it’s more than just a battle over salt. She sees this issue as just another example of the FDA taking authority away from state regulators and telling consumers what they can eat. “Unfortunately, I think we’ll see tougher FDA actions in 2012 against a food supply chain that is already safe and probably doesn’t need additional regulation like this.”

When trying to predict what will happen in 2012, it’s important to recall that the Food Safety Modernization Act, signed in January 2011, ushered in a new era of increased security measures, processes and controls for food safety officials; most orchestrated by the FDA, notes Don Hsieh, director of commercial and industrial marketing with ADT Security Services. He works to educate brands on how to build a proactive food defense program and how food officials can effectively comply with FDA regulations.

Simply put, the FSMA is the” most significant expansion of food safety requirements and FDA food safety authority in over 70 years, since the original Food Drug & Cosmetic Act in 1938,” Hsieh says.

And FDA is clear on its intent. “The historic FSMA is aimed at transforming our food safety efforts toward prevention and based on risk analysis” said LeeAnne Jackson, PhD, Health Science Policy Adviser, FDA.

Hsieh reminds us that recalls are bad for business, to put it mildly. One of the largest food recalls was the recall of peanut products produced by Peanut Corporation of America. What resulted from this mass distribution of contaminated product were 714 confirmed infections, nine deaths and $1 billion in losses to the United States peanut industry. The Peanut Corporation of America filed for Chapter 7 bankruptcy and its owner and CEO appeared before Congress under Congressional subpoena. Although the cause of the outbreak was one firm and did not involve major peanut butter brands, consumers reacted by avoiding the peanut butter category and sales plunged 25% after the recall announcement. “This points out the importance of not only protecting the food supply chain for your company’s products but being able to prove that your supply chain was not impacted by a specific incident,” he sums up.

But are food processors ready for 2012? Doesn’t sound like it. As Hsieh points out, for most food manufacturers, “documentation is typically done by a person with a clipboard checking off items on a paper check-off list. Given FDA’s mandate of providing documentation of compliance, these documents may not accurately reflect compliance and are difficult to access and compile.”

Looking ahead to 2012, that’s probably an understatement.

 

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Filed Under: FDA Regulated, Food, Michael Causey, Regulatory Tagged With: , , , ,

2012 Crystal Ball Predicts a More Aggressive FDA

December 15, 2011 By Leave a Comment

Patrick Stone, President, TradeStone QA

Will 2012 be a Mayan prophecy year of doom and gloom at FDA or will they get the job done for US/global public safety? According to the FDA website, 2012 will be a year of global regulatory operation and enforcement with emphasis on medical devices, drugs, and food products. Will the 2012 budget from congress for FDA provide the necessary funds as supplemented by MDUFA and PDUFA to complete this global mission?

Third party audits may be a new driving force in the completion of this bold global mission as with the European Union ICH mandates. How will FDA review the third party audits and enforce them accordingly?

The growing pains of letting go of the steering wheel may take FDA some time to get used to. Trusting international “accredited” third party audits may take some time for FDA to digest, too. FDA is used to being in the driver seat for all aspects of firm review and enforcement especially for medical devices and drugs. There may be an uptick in regulatory action internationally and some more supply chain shortages in both medical devices & drugs due to expanded review process.

FDA logoDomestically, FDA will try to inspect the few medical devices & drugs manufacturing firms left within our borders. The focus may be on dietary supplements and food firms in order to meet congressional mandates for the Food Safety Modernization Act (FSMA). I can only hope that FDA mandates better labeling for our food products with strict guidelines on labeling the percentage of that food product which is imported.

According to FDA,”Nearly two-thirds of the fruits and vegetables–and 80% of seafood–eaten domestically come from outside the U.S.”

As consumers we need to be able to make informed decisions about the food we eat and where it is harvested. Processed foods are not labeling the percentage of imported ingredients within their product. FDA should also focus on human clinical research domestically with an emphasis on training inspectors to complete this goal. We may have lost domestic manufacturing for medical devices & drugs — however human clinical trials have not decreased at the same rate.

Clinical trials must be conducted domestically in order for the test article to be marketed in the US. Logic should dictate that FDA review more of these medical devices & drug human clinical trials. Unfortunately political appointees with no FDA experience lead the mission here, so logic and science are not always a driving force. The field investigator can only do what they are told not what is logically necessary to complete the public safety mission.

Crystal balls aside, let’s hope 2012 is a better year for the FDA.

Read more about FDA’s 2012 inspectional and enforcement trends here.

Patrick Stone is the author of Bubble Gum Badge – An FDA His-Story. You can also follow him on Twitter.

 

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Filed Under: FDA Regulated, Food, Medical Devices, Patrick Stone, Pharma/Biotech, Regulatory Tagged With: , , , , ,

Obama Executive Order on Drug Supply Misses The Point

November 14, 2011 By Leave a Comment

Patrick Stone, President, TradeStone QA

The Obama Administration’s recent Executive Order Reducing Prescription Drug Shortages states that some health care providers may hoard drugs that are in short supply.

I am wondering how this is possible if the drugs are not even available to hoard? In this Executive Order it specifically states that root cause analysis and solutions may be out of FDA control. Only the US Congress may appropriate funds for HHS/FDA work force initiatives.

According to the Executive Order, pharmaceutical manufacturers are requested to report timely drug manufacturing discontinuances. But the order clearly misses some important points. The problem is that FDA already knows about drug discontinuance when they order a hold on product or issues a 483 for GMPs with a warning letter follow up.

Moving drug manufacturing out of our country further compounds this drug shortage. It may take years for a drug firm to re-start operations after a move from the US. The fact our US government gives incentives to big drug manufacturers to leave the US with huge tax breaks is also part of this problem.

Generic Drug TabletShipping drug manufacturing to India and China for cultural exchange or to bring up the standard of living is a slow process filled with FDA/GMP regulatory pitfalls. Expedited regulatory review must take place where the pharmaceuticals are manufactured, many of which are overseas.

I am not sure how this is possible when most of the FDA’s funds are already earmarked for FSMA food priorities and congressional mandates. I do applaud Sec. 4 mandating the FDA to communicate with the US Department of Justice (DOJ) on price gouging and hoarding to seek enforcement actions. I am still wondering how hoarding will be possible if the drugs in short supply are not available at all.

This short and sweet Order will hopefully prod the US Congress to address this problem with the full force of the US constitutional authority. Time is a luxury factor we do not have. As I stated before in a previous blog, the pharmaceutical industry and FDA must collaborate to mitigate further risk to national security.

Patrick Stone is the author of Bubble Gum Badge – An FDA His-Story. You can also follow him on Twitter.

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Lilly CEO Calls on FDA to Lighten Up

November 8, 2011 By Leave a Comment

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

The FDA has to speed up adoption of a “Benefit-Risk Framework” to improve decision-making in the regulatory process, said John Lechleiter, Ph.D., chairman, president and CEO of Eli Lilly and Company.

Speaking at recent industry conference, the CEO of the drug giant called for a regulatory process that focuses both on recognizing and appreciating benefits while identifying and minimizing risks. Such a balanced approach would help increase the flow of needed medicines to patients and reverse a trend of fewer new drugs getting approved, he said.

“The stakes are high,” Lechleiter said. “The only way to make inroads against [chronic and other] diseases is to sustain the pace of medical progress.”

The FDA appears to be a bit on the defensive here. It recently issued a report touting its record approving drugs it says demonstrates it isn’t stifling innovation at all thank you very much.

The backdrop to this battle is the upcoming reauthorization of the Prescription Drug User Fee Act (PDUFA) V. Originally enacted in 1992, PDUFA and its iterations set the foundation for how FDA will manage the drug review process for five years, beginning in October 2012.

Lilly’s Lechleiter stressed the importance of a non-partisan course for reauthorization. “As a basis for the drug review process, PDUFA is too important to get bogged down in partisan politics,” Lechleiter said. “As Congress considers reauthorization next year, we hope to see a ‘clean’ bill – one free of extraneous and controversial provisions that would politicize the bill and further complicate matters for all parties.”Lechleiter said the regulatory system must continue to evolve to meet 21st century needs.

Lechleiter offered five key characteristics of a “state of the art” regulatory approval system:

  1. Timely – “There are far too many conditions for which therapy is inadequate or nonexistent. We need a system that is not only effective, but efficient as well.”
  2. Predictable – “The system must be predictable in its judgments, its decisions, and the criteria on which those decisions were based – whether scientific, ethical, legal, etc.”
  3. Consistent – “The system must be consistent across review divisions using standardization and repeatable processes – so that an innovator clearly understands the regulatory requirements and so that institutional learning can be harnessed to replace time-consuming one-off learning by review groups and division.”
  4. Transparent – “The system needs to be transparent in its judgments and criteria so [stakeholders] understand the rationale for its decisions.”
  5. Scientifically rigorous – “This requires scientific expertise within the agency – or access to the expertise – that understands, engages in, and influences the constantly evolving external scientific environment and ensures that standards are up-to-date.”

Lechleiter also discussed ways to strengthen a medicine’s benefit and lower its risk, including calling for greater emphasis on improved outcomes for individual patients, through the development of tailored therapeutics.

“From the point of view of patients and their doctors, a tailored therapy will provide a better benefit/risk trade-off, because they can have a higher degree of confidence that it will work effectively and with minimal harmful side-effects relative to the benefit obtained,” said Lechleiter. “From a value-for-money standpoint, tailored medicines should also reduce the heavy costs associated with non-responders. In other words, payers will get what they are paying for.”

Cry havoc and let slip the dogs of war. This one isn’t over by a long-shot.

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Filed Under: FDA Regulated, Michael Causey, Pharma/Biotech, Regulatory, Risk Management Tagged With: , , , ,

Former FDA Inspector Calls for Increased International Inspections

November 3, 2011 By Leave a Comment

Patrick Stone, President, TradeStone QA

Here’s an idea: More FDA inspections outside the US, at a lower cost.

How?

If FDA trained other countries health organizations to conduct FDA business with Memorandums of Understanding (MOU), less money could be used to travel with more inspections completed. This training could be accomplished online and by going out with FDA International Investigators. The EMA should have a MOU if their model is similar to FDA’s. The advent of all electronic review should alleviate the need for more international inspections.

I admit I may be over-simplifying the issues with training monies and bringing foreign inspectors to US training facilities. But I think the basic idea holds water.

Host nations can send their inspectors for knowledge sharing and training with justifiable beneifits to the host nations public health. FDA can also video link for training, as is done currently for new hire training.

FDA logoUnfortunately, innovative options are scarce at the FDA Senior Executive Service level (SES) and the old way of doing business is ingrained into the government model. For the short term FDA will try to increase international inspections in all program areas with a focus on food work.

I’ve observed many international drug and device firms receiving warning letters and multiple item 483 forms. If this current warning letter trend continues, the blame may fall on lack of FDA regulatory guidance.

The core mission of FDA is to protect the US public from harmful health products. Sending FDA field Investigators to where the products are manufactured and undergo human clinical trials is one of the only ways to accomplish the core mission. Ensuring that field investigators are proficient for the task and seasoned investigators stay engaged will be the challenge.

The international firms with compliance issues should be reviewed by their country’s FDA equivalent for cross training on regulatory compliance.

On the job training is used here at home as a component of new hire training. FDA will have to think outside the box if Congressional Mandates for International travel are to be met.

Congress must also understand that it is not only the amount of funds that insure successful international travel, it is also about proficient field investigators as well.

I have faith that FDA field staff will answer the challenge because they always do.

Patrick Stone is the author of Bubble Gum Badge – An FDA His-Story. You can also follow him on Twitter.

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Filed Under: FDA Regulated, Food, Medical Devices, Patrick Stone, Pharma/Biotech, Quality Management, Regulatory Tagged With: , , , , , ,

FDA Promises ‘Sea Change’ in Food Regulation

November 2, 2011 By Leave a Comment

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

The new mantra for food manufacturers better be prevention, prevention, prevention according to current and former FDAers commenting on the January 2011 passage of the mammoth Food Safety and Modernization Act.

“This law represents a sea [of] change for food safety in America, bringing a new focus on prevention…” FDA Commissioner Margaret Hamburg says.

But former FDA Commissioner of Foods Dr. David Acheson takes it further in a new white paper from Plex Online. The new law “will result in significant changes for FDA-regulated food manufacturers and processors.” FDA’s emphasis on prevention will require registered facilities to develop and maintain a written food safety plan, for starters, Acheson stresses in a new white paper “Food Safety plans: New Requirements for Registered Facilities.”

As we’ve blogged before, most registered food facilities will be required to develop a clear, detailed safety plan that documents the facility’s:

  • Prerequisite programs are in place to ensure food is produced in a safe and sanitary manner;
  • Hazard analysis that identifies all potential risks throughout processing;
  • Preventive controls that are implemented to mitigate risks;
  • Monitoring of preventive controls to ensure they are properly implemented;
  • Verification that the preventive controls have the intended reduction in risk; and
  • Re-analysis of the hazards and preventive controls when there are significant changes in the process or every three years.

Acheson, now with Leavitt Partners, notes that regulated entities must soon be “able to quickly access records and demonstrate compliance with the food safety plan requirements.” They’ll also be expected to have “implemented a robust food safety program” if they want to maintain a position as a food safety leader.

He advises regulated entities to develop well-documented safety plans with strong monitoring procedures and corrective actions, for nine key areas:

  1. Facility Information: Facilities will need to document a description of the food, the methods of distribution and storage, the intended use and intended customer for all products produced.
  2. Prerequisite Programs: These programs will require a written plan, established monitoring procedures, established corrective action procedures, and an established recordkeeping system.
  3. Hazard Analysis: Facilities will be required to conduct and document these to identify potential product-related hazards, including biological, chemical, and other hazards such as terrorism.
  4. Preventive Controls: Once identified, each hazard must be evaluated to determine the significance of the hazard if it isn’t controlled, the likely occurrence of the hazards, and if it constitutes a “critical control point” that must be addressed.
  5. Monitoring: Each critical control point must be then monitored to ensure compliance with the critical limits.
  6. Corrective Actions: Beyond on-going monitoring, facilities must establish and document procedures for taking proper and effective corrective actions when critical limits aren’t met.
  7. Verification: Facilities will then need to verify that the preventive control and critical limits result in the intended control and reduction of hazard.
  8. Record-keeping: The new legislation authorizes the FDA to request access to a regulated entities’ Food Safety Plan. Each entity must establish a record-keeping system that documents their hazard analysis, critical control points, monitoring, verification, and corrective action plans and follow-up.
  9. Re-analysis: facilities are required to conduct one of their food safety plan and hazard assessment whenever they implement significant changes or every three years.

It will take some time for the FDA to decide exactly how it will enforce the new law, and its interpretation will clearly have some impact on food manufacturers and other regulated entities. But it’s equally clear that the new law means big changes for companies that make food for a living.

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Filed Under: FDA Regulated, Food, Michael Causey, Quality Management, Regulatory Tagged With: , , , ,
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