Tag Archives: GMP

Vitamin Companies – Ask Your Contract Dietary supplement Manufacturer These three Inquiries About G

If you’re a small , you deal with a whole new set of issues starting this June. On June 25, smaller supplement and vitamin companies join large and medium sized organizations in staying necessary to meet the FDA’s current very good production practices (GMPs).

These GMPs are basically a long time coming. When it was handed in 1994, the Dietary Dietary supplement and Overall health Training Act (DSHEA) required that the FDA set up and enforcing GMPs. But it wasn’t right up until 13 years later on, in 2007, that the FDA eventually itemized them. In 2008 the FDA began enforcing them with big manufacturers, followed by medium-sized makers in 2009.09.

Now, it’s your flip.

For Modest , GMPs Provide Positive aspects As Properly As Difficulties

Even though to some extent these regulations may possibly look onerous, they basically are a boon to an sector challenged by uneven criteria and the client mistrust that comes with it. For this explanation, numerous companies have welcomed the enforcement of these very long overdue rules. Industry gurus predict that the enforcement of GMPs will increase the industry’s picture and boost the by now continuous industry progress for nutritional supplements.

Nonetheless, earning certain you survive this challenging yr could require some significant alterations in your manufacturing course of action. And it absolutely indicates that you need to have a strong manufacturing partner who is prepared to enable you meet compliance with no a hitch.

To make certain you have the correct companion, the following are 3 strategic questions to inquire them about GMP compliance:

1.What has been your history of applying GMPs to your production approach and what are you carrying out now to insure you’re compliant?

Long before the FDA’s GMPs went into effect in 2007, many quality companies followed very good production practices borrowed from the pharmaceutical marketplace, other nations, or established informally within just the nutrition industry alone.

It’s definitely doable that some organizations will be able to establish compliance with constrained adherence prior to the establishment of FDA suggestions. But there are clear rewards to working with a companion who has made most of the move presently:

A organization that has been following GMP recommendations ahead of the FDA enforced them is more possible to have a core commitment to good quality. Wouldn’t you somewhat function with a manufacturer who has on its own invested in excellent manage instead than a single forced into it by regulation?

Secondly, acquiring the appropriate tools is an individual matter… Having personnel knowledgeable in employing the tools is a different… And possessing a organization tradition created by these knowledgeable people today – a tradition that previously focuses on looking for issues, spotting them and attending to them – is even much better.

Applying GMPs successfully to manufacturing takes additional than just new equipment or even new personnel. It can take a firm that has woven superior manufacturing into the way it operates. With nicely-tested systems and seasoned people today in put, it can meet GMP needs effectively.

2.Do you use any type of internal auditing to catch issues just before an exterior inspection does?

At one stage or other, the supplement producer you’re operating with will have an FDA inspection of the plant. Hopefully this will go easily with probably a couple of recommendations, but no main problems.

However, the only way to guarantee that there are no disturbing surprises is to be proactive by checking for compliance before the inspector comes. To this finish, see if your dietary supplement producer has set up an inner audit method.

With this process, an inner audit staff routinely pays surprise visits to different departments and assesses their functionality. The team’s reviews enable to initiate discussions, repair issues and increase creation methods. Ideal of all, this comes about before you have an FDA inspector breathing down your neck.

three.How will the implementation of these rules influence my manufacturing charges and timetable?

Just about all vitamin manufacturers have had to make some adjustment to meet new regulations. This contains expenses like new gear, new facilities, or employing new personnel. And these demands have also introduced new schedules to accommodate new methods or added actions like raw materials evaluation. The two the expense and the scheduling can conclusion up impacting your manufacturing prices and agenda.

These new costs are unavoidable. Some firms will not be able to meet the new expenses and will stop up closing as a end result. The ones that pull through, on the other hand, can seem forward to enhanced consumer self-assurance that can only raise the nutritional dietary supplement industry’s constant expansion.

In the brief run, a very good spouse will not only share the increased money burden with you but will also work with you to search for price tag price savings. Potentially it means securing new raw substances or scaling up your manufacturing to larger runs. Perhaps it implies identifying new packaging that will enable you save on shipping.

A good dietary supplement producer will support you seem for alternate options that can aid you proceed creation in a timely manner without having dropping a balanced earnings margin.

For A Productive Partnership, Request Your Dietary supplement Manufacturer These Queries

Meeting these new specifications will challenge your small business on a lot of fronts. By partnering with a good agreement producer, on the other hand, you can streamline the adjustments to these alterations and guarantee your goods and enterprise are compliant.

If you’re already working with a contract producer, inquire your spouse these 3 queries. By doing so, you’ll obtain a deeper insight not only into their potential to meet GMP demands, but also their dedication to do the job with you in creating high high quality items and a powerful enterprise. This discussion will make your partnership a productive an individual.

On the other hand, if your agreement supplement manufacturer companion are unable to aid you meet these requirements to your satisfaction, search for one who can. You’ll avoid a great number of headaches by obtaining a sound GMP-compliant manufacturer. Use these questions as part of your initial interview process.

Vitamin Supplement Manufacturer: Fusion Formulations
So you want to build a successful vitamin supplement branded product. Welcome to the world of Fusion Formulations – a leader in customized contract manufacturing of nutraceutical, vitamin, supplement, mineral and botanical tablets, capsules and powders, plus nutraceutical beverages.

Achieve Maximum Sale For Your Dietary Supplements Products

The supplements market is booming as people have realised the numerous benefits that your health stands to gain from supplements. To be able to penetrate this market you need the latest trends in the supplements field for marketing. Private label for dietary supplement services is now the way to go.
Before looking for a private label for dietary supplement manufacturer you should take into consideration what is needed for the manufacture of supplements. Here we consider points such as the supplement formulation, manufacturing process and packaging. A private label for dietary supplement manufacturer should be a well reputed OEM drugs manufacturer of supplement products and should also have a GMP license as a minimum.
Your supplement product should deliver the best results. The only way to ensure this happens is by enlisting a private label for dietary supplement company that has experts who are professionals in the fields of nutrition and toxicology. N.D. chemists, Ph.D. pharmaceutical scientists and regulatory compliance specialists are such persons who have the requisite expertise and tools to ensure that your dietary supplements will provide your customers with maximum benefits.
A company that offers private label for dietary supplement services has to be an all inclusive company; this company should have state of the art pharmaceutical manufacturing equipment that is flexible enough to manufacture different products from different customers. Your private label for dietary supplement company of choice should have a packaging line that can be able to provide for solid dosage e.g. gelatine encapsulation, film and colour coating, tablet press and so forth. The facility of choice should be able to manufacture small lots to large batches at affordable rates. This is especially good when catering for small or large demands from the market.
The quality control systems in the private label for dietary supplement facility should be GMP approved. This facility should have an in-house analytical laboratory capable of testing for microbial activity and heavy metals. A private label for dietary supplement company that incorporates third party lab testing of their products into their testing procedures is an added plus.
You would not want your dietary supplement products to be the first product a private label for dietary supplement service facility manufactures; the risks of the product failing in the market will be too high. On the contrary, look for a company that has wide and long experience in offering private label for dietary supplement services and which brings added value to its customers.
Nutralab Canada is a leading contract manufacturer that provides private label for dietary supplement products service. They have more than 10 years experience offering this professional service to customers all over the world.

Today , our consumer has highly appreciated the value of private label dietary supplement products defined by scientific based formulation, properly manufactured using top quality ingredients, sold at a very competitive price. It is no longer true and hardly success as it used to be by copy the most popular product and make it cheaper. Today, private label success highly relies on quality and effectiveness of products for that it may need our investment and commitment.
when choosing a private label partner, most important criteria should be someone who know and understand the quality standards both in ingredients and good manufacturing process ( GMP) , as well as overall industry experience in scientific and regulatory supports to the finished product formulation, testing , marketing and compliance.Ultimately, your private label partner should have the ability to produce a high quality product in a timely manner for a reasonable price.
We, at Nutralab Canada, will be your good partner that you can stand behind with confidence for your success !

Dietary Supplements Are They Dangerous

Dietary supplements refer to any health products that can supplement our diet. They include vitamins, minerals, amino acids, digestive enzymes, Probiotics, herbal supplements, glandular extracts and dietary fibers etc.

The consumption of dietary supplements has been rising every year. Whereas many people believe that dietary supplements can improve their health or prevent certain diseases, some consumer groups or medical professionals have warned that dietary supplements can be dangerous. So, the question is: are dietary supplements really dangerous? Unfortunately, the question does not have a simple answer.

Dietary supplements, by its broad definition, include thousands of different products. In 2004, Consumer Reports listed 12 potentially dangerous dietary supplements. Many of them are herbal products. Some of these herbs have been used by herbalists for hundreds of years and are considered as safe. However, when the active substances in these herbs are extracted in pure or concentrated form and consumed over prolonged period, they can be dangerous to some people.

Many dietary supplements such as vitamins and minerals are safe and can supplement what is missing in our diet. However, even the benign supplement can become dangerous in overdose. In local news, a woman was reported to give her two teenage daughters mega dose of vitamin A for prolonged period, thinking that the supplement is good for the eyes. Both suffered from acute liver failure and one required a liver transplant to save her life. Vitamin A is not dangerous but mega dose of vitamin A is hepatotoxic. In this case, ignorance itself is dangerous!

The quality of dietary supplement is also an important factor. The presence of contaminations, such as heavy metal, drugs, and toxic substances can make a benign supplement dangerous. One example is the presence of microcystin toxin in blue green algae dietary supplements. Microcystins are natural toxins from certain strains of blue green algae that can cause liver damage and liver tumors. According to the research conducted by Health Canada, only one strain of blue green algae, Spirulina, is free from microcystins as Spirulina is harvested from controlled ponds. Most of the non-Spirulina blue green algae supplements are contaminated by microcystins, especially those harvested from natural lakes. Daily consumption of these dietary supplements would exceed the acceptable level of microcystin intake established by Health Canada and WHO.

Good manufacturing practice (GMP) is another key factor to safeguard the quality and safety of dietary supplements. Dietary supplement manufacturers in compliance of GMP standards have to test the identity of raw materials, implement a quality control unit, provide expiration date for the finished products, maintain good records of batch production and written procedures, and hire personnel who are trained to understand and follow GMP. This practice can reduce the chance of having batch to batch variation in strength, composition, purity and quality of finished products.

To sum up, although most dietary supplements are safe when consumed according to the label, consumers are advised to educate themselves before taking these supplements. What are the functions of these supplements? How long should I be taking them? Are they manufactured by reputable companies in compliance of good manufacturing practices? Never consume more than the recommended dose unless supervised by health care professionals. If you are pregnant, breast feeding, or suffering from pre-existing health conditions, you should also take extra precaution and consult with your doctors or nutritionists.

Increased Trouble for Dietary Supplement Liability Insurance Applicants

On Dec. 22, 2007, a bill signed by President Bush a year earlier became law. It set a required reporting system of profoundly adverse events (SAE) for dietary supplements sold and used in the United States. With further requirements, it mandated the company whose name appears on the product hold records related to every report for six years from the time the report is initially received.

In spite of this, just those adverse events that are “serious” must be reported. The definition of “serious” is understandable and includes, but isn’t restricted to, death, a life-threatening experience and in-patient hospitalization.

But has any person studied the implications of not disclosing SAE reports to their product liability insurance carrier? No, and the consequences of not doing so could be dire.

Almost each application for product liability insurance for dietary supplement companies has a question identical or very similar will this: “Is the applicant aware of any fact, circumstance or situation which one might reasonably expect could give rise to a claim that would fall within the scope of the insurance being requested?” Companies subject to the new SAE notification requirements should think about this subject carefully prior to responding either “yes” or “no.” If a business is maintaining the required SAE records, can the company in good faith answer “no” to the question? Hardly.

And what are the aftereffects of answering the question falsely? Put plainly, if a lawsuit arises from a previously documented SAE incident, the insurance company will confidently deny the claim after it discovers (and it will) the SAE was documented in the companys records. The insurance company will allege fraud for inducing it to issue a policy based on concealed information. It will not simply deny the claim, but most likely will look to rescind the policy completely.

Thus, the latest SAE reporting requirements have introduced a new necessity to disclose such events to a product liability insurance company when applying for the insurance, or risk a claim turned down when a claim is created.

The GMP (good manufacturing practice) inspection procedure holds comparable risk. It is well known the amount of FDA inspections for GMP conformity have risen dramatically. According to FDA data, only seven GMP inspections occurred in 2008, which increased to 34 in 2009 and to 84 in ’10. As of Sept. 13, there have been 145 inspections in 2011. A lot of of these inspections have resulted in warning notices to companies citing a range of violations and calling for a swift reply outlining remedial steps to be followed. These letters are a matter of public record and can be seen on the FDAs website. With the number of inspections and enforcement undertakings overall on an abrupt rise, it stands to reason that more companies will be receiving a warning notice of some gravity in the near future.

An additional question on nearly all product liability applications is virtually the same as or identical to this: “Have any of the applicants products or ingredients or components thereof, ever been the subject of any investigation, enforcement action, or notice of violation of any kind by any governmental, quasi-governmental, directorial, regulatory or oversight body?” Once more, a “yes” or “no” answer is called for. If a business has had an audit that resulted in a warning letter, it again should ponder carefully before answering the question. If the company has been issued a warning notice, the only logical response to the question is “yes.”

Tips To Selecting A Dietary Supplement Liability Insurance Broker

Insurance premiums for commercial general liability, including product liability, have declined in recent years but still remain a significant cost for all sectors of the dietary supplement industry. In addition to premium cost, companies must be concerned about} two other critical aspects of product liability insurance.

The first is the limits of insurance needed. In prior years, most companies were able to satisfy customers with limits of $1 million per occurrence/$2 million aggregate. However, during the recent “hard market” for liability insurance, many of the large retailers raised their vendor requirements to $5 million.

The second important consideration has to do with the coverage, in particular the ingredient exclusion that each insurance company attaches to their policy. These ingredient exclusions apply to both single-ingredient products (for example, St. John’s wort) and to any formulated product containing an excluded ingredient. These exclusions vary greatly and are continuously changing. Regrettably, with each negative press release or 60 minutes segment,the list of excluded ingredients is getting longer, not shorter, so care must be taken to be sure that the ingredient exclusion attached to a company’s policy maximizes the coverage for the products that it sells.

What are the qualities a company in the dietary supplement business should look for when selecting a retail insurance broker?

Specialization in the Product Area: A broker with just one or two clients in the dietary supplement business may not be bound or motivated to be on top of industry issues on a daily, weekly or monthly basis. In addition, brokers who have active accounts in the industry should be capable and agreeable to share references to accentuate their performance claims. It is also beneficial to ask for a copy of a typical underwriting package shown to wholesale brokers for companies characteristic of your own.

Understanding the Issues: Busy brokers within an industry such as the nutraceutical market know the importance of understanding industry issues and act to stay informed, including attending trade shows and industry networking events. Companies can gauge a broker’s industry experience by the questions the broker poses about the company’s business operations. For example, an experienced broker could ask questions about your company’s GMP (good manufacturing practice) standards, manufacturing certifications and association memberships.

Insurance Industry Connections: A competent retail broker should be able to readily name all of the current insurers for product liability and ascertain specific traits of each one (minimum premium, ingredient exclusions, minimum and maximum deductibles, etc). Also, companies should review whether the retail broker’s wholesale broker has knowledge of, and is dedicated to, the dietary supplement industry.

Logistical Abilities: It is crucial to ensure the retail broker selected has adequate support staff to service your account-issuing certificates of insurance promptly and answering routine questions in a timely, accurate {manner|way}, for example. In addition, it is worth reviewing whether the broker can deal with other insurance options for your company, such as workman’s compensation or fire coverage, if need be. If you sense that it might be time to consider a new retail broker, don’t wait until the renewal quote arrives. Start seeking alternatives at least three months prior to the renewal date; a motivated, professional retail insurance broker will give good advice and answer questions at any time, regardless of renewal date.

Selection of an insurance broker is a highly technical and critical matter. All the principals of the company should be involved in the decision. If the selection is made with these stated criteria in mind, the result will be maximized protection of company assets from insurable legal liability events.

How to choose good dietary supplements

Any shopper who walks into a grocery store, health food store, pharmacy or searches online is confronted with thousands of dietary supplements. How does a consumer know what to choose?

Listed below are some questions to ask when choosing good dietary supplements:

1. What information is printed on the label?

The label should indicate the names of the nutrients and the amounts contained, the forms used of the ingredients, and the number of tablets. The label should also provide you basic information about the company (address, contact information), recommended dosage, manufacturing dates, and expiration others.

2. How reliable is the supplement company?

There are several factors to check about the supplement manufacturer:

Is the supplement manufactured under good manufacturing practice, GMP?

Does the manufacturing process eliminate the risk of product contamination or incorrect labeling?

Were the supplements tested independently for purity and strength?

Does the manufacturer have good quality control?

Is information freely available on the company website or in the product literature?

Does the company have a customer service phone number or department and are they willing to answer questions?

3. How many products does the company offer?

It there is only one item, the company may not have a full range of supplements that can work together in a complementary fashion. They may also just produce one product to cash in on current fad. If the company has a wide range of products, they probably have a lot of knowledge about combinations of supplements that work well together. Those companies are automatically copying the synergistic elements found in nature.

4. How is the supplement being delivered to the consumer?

Is the supplement in a pill, powder or liquid? Often a pill is too compressed to dissolve easily in the stomach and it passes through without be adequately digested. The label should state that the tablets meet the USP dissolution standards and so they will dissolve in the stomach. An even better choice is a supplement that is manufactured in a powder form that can be mixed with water. This kind of supplement is very easily absorbed in the small intestine.

5. How knowledgeable about the supplement are the workers at the store?

A store that sells quality supplements usually has staff that are knowledgeable about the products. They can guide customers toward the right products based on the customers’ needs. If the worker can not explain why one particular supplement is better than another or how they are different, then the manager should be consulted, the literature in the box perused, or the company website investigated.

The recommendations of friends or relatives can certainly provide some point of reference but the information provided by experts is more trustworthy. Anecdotal information cannot be verified or substantiated. Since each person’s body is different, the results might not be the same for each person.

Supplements are valuable and necessary additions to good nutrition and healthy living, but they should not be consumed on a whim or without full knowledge of their properties or effects. The purpose of dietary supplements is to enhance health. If the wrong supplements are chosen, they will not perform the way the customer wants them to. Possible ill effects could be suffered and money will certainly be wasted.

Dietary Supplements And Nutraceuticals Compliance With Fdas Current Manufacturing Requirements

Recently FDA announced an aggressive campaign to enforce the Good Manufacturing Practices (GMP) regulation on manufacturers and suppliers of dietary supplements in the US. Also, a vast majority of supplements are imported from manufacturers located in countries with poor GMP requirements for such products.

To address these issues, FDA now requires manufacturers of dietary supplements to follow GMP requirements closer to those for drugs than those for foods. These requirements include stricter documentation, standardized processes, use of trained personnel, adequately designed facilities, quality testing, packaging and shipping, and audit trails of processes. These requirements have created lots of anxiety in an industry filled with small businesses with few products, and international companies marketing in the US.

Compliance techniques can be simple and implemented with relative ease leading to better products both in terms of quality and potential benefit to consumers leading to better acceptance.

If you are a manufacturer, importer, supplier, stocker, marketer, shipper, or user of dietary supplements, this webinar will describe the US GMP requirements and techniques to be compliant using easier, shorter and convenient strategies. We will discuss ways to demonstrate compliance to the current regulations and regulatory trends for the near future. Common findings and possible solutions will be discussed. Case studies will be presented for audit experiences in many countries including US, China, Israel, Taiwan, and India.

Areas Covered in the Seminar:

– Key manufacturing issues related to dietary supplements and nutraceuticals.
– Raw material sourcing, validation, accountability, and documentation techniques.
– Facility design and planning issues.
– SOP and training requirements.
– How do these changes impact products currently in the market.
– Techniques to ensure compliance at international manufacturing sites.

Learning objectives:

Learn how to be compliant with current GMP requirements in the US for dietary supplements in less than an hour to increase credibility of existing products and make it easier to launch more products in the US market in the near future.

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

– Manufacturers and marketers of dietary supplements
– QA/QC/Compliance/Regulatory affairs professionals
– Regulatory and quality professionals working in companies involved in manufacture and sale of dietary supplement, nutraceuticals and similar products
– Regulatory and quality professionals working for US companies that are considering the purchase of such products manufactured in non-US markets or vice versa
– Regulatory, compliance and quality professionals consulting with companies developing such products for the US market
– Business professionals looking to understand the risks and benefits of investing in such products
– Senior management of such companies in India, China, Africa and Latin – America considering marketing their dietary, nutraceutical and similar products in the US

Instructor Profile:

Dr. Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD ( www.amarexcro.com ). His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide.