Does GMP Compliance Mean A Quality Assurance Process Providing High Quality Supplements?

Sunday, December 27, 2009

By : Wanda McCormick

Fact… 45% of all supplements you buy are defective in some way. Will the GMP change that?

Until now there have been no laws requiring the label to accurately tell you what is actually in your bottle of vitamins or supplements. So the government has begun requiring certification programs that must be verified by an independent lab on all supplements and vitamins. The GMP or Good Manufacturing Practice certification will begin in 2009. This verifies quality control, cleanliness, checking the identity and potency of ingredients, and testing of the final products for potency, purity and authenticity.

There will be plant inspections to observe cleanliness. This was implemented due to truly filthy conditions observed in equipment used to process and bottle supplements. I saw a picture of one that was processing a powder with cob webs actually inside the machine’s duct work and powder everywhere, on the floor, handles and knobs. If the powder could get out so easily and spiders could get in, then what insects etc were actually in the powder?

Testing will be done on raw materials coming into the plant. This is due to so many instances of products coming from overseas that were not what they were supposed to be. In order to make more money the products were “cut” with other less expensive ingredients. In one instance China companies added Melamine to baby formula. Melamine is used to make the plastic place settings you see in department stores. 13,000 children were hospitalized after drinking the tainted baby formula. 22 companies were involved and the contaminated formula had been sold all over the world. Chinese parents were in a panic not knowing what was safe to feed their infants. Other examples of contaminants include heavy metals foune in 25% of products coming from both India and China. What makes this so dangerous is that manufacturers are buying “boat loads”, literally, of product and just putting them into capsules without any product testing. Whatever is in the imported powder goes right into your capsules.

Then there will also be testing of the final product for potency, purity, and authenticity. Potency just means that the amount listed on the label is actually the amount in the bottle. For example is there really 500 mg of Vitamin C in each pill? Many times the making of the finished product uses heat which destroys some of the potency, but the label lists the original potency of the raw product.

Let me give you an example, whey protein comes from milk. One way it is taken out of the milk keeps just about all the whey protein undamaged. Another way to remove whey involves heat which is a cheaper process. It keeps the cost down, but destroys some of the protein. Labels will now be required to reflect this difference in potency. Purity means that the final product contains no contaminants, like heavy metals, insect parts or melamine.

Authenticity means that the final product is what it says it is, that a bottle of calcium really is calcium. Until now 10% of what you buy on the shelf doesn’t even have the main, active, ingredient in it. Sometimes it is just a powder or pill that looks like the real thing. One of the articles I read talked about a companies problems with it’s product. It was not what it was supposed to be. It turned out the independent lab that was doing the testing for the manufacturer was using “visual testing” to tell if the product was pure or not. This entailed putting a special wavelength of light on the powder and if the product glowed then it was considered pure and authentic. What they didn’t take into consideration was that other powders also glow under that same light. While this was a cheaper test that helped to keep cost low, it did not do what it was supposed to do! While the more expensive chemical testing easily showed the product had been "cut" with something else and was not pure or authentic.

The upside to all this is obvious, that we will “really” get what we are paying for. It will provide the real health benefit it is supposed to and it won’t make us sick from contaminates. But there is a down side. Foreign suppliers will have to export the real thing or we won’t buy it. With all the super cheap products no longer available, the demand and the price for the real thing will go up. Also manufacturers will have to replace outdated equipment, set up quality controls and in-house testing or hire independent labs. Some will not be able to afford the updates and will go out of business. Even if the manufacturers are able to upgrade, they will still have to pass government testing in order to be certified and some will just not pass. Those manufacturers that do survive will see a higher demand for their products, which will generate more sales to offset the added costs, but most likely will still pass the increased cost along to us, making our supplements cost more.

The silver lining is that there are manufactures out there that already do all this and won’t be effected,and have always given us the best possible products. Now everyone will know who they are. Sometime in 2009 you will start to see symbols on the certified products testifying to their quality. Look for the GMP stamp of approval. You can see some of the symbols on my website at http://thebestproteinshakes.com/numbers-dont-tell-it-all/ and Dr Kones who helped me write this article has volunteered to answer any questions about nutrition you might have. His email address is on the same page as the Certification Symbols.

My site discusses Protein powders and how much they vary, so it is crucial to know what's in them. It's http://www.thebestproteinshakes.com/. Visit and let me help you compare the different types of protein powders. It shows how to read and understand the labels. Then it helps you sift through it all to find the best protein for you.

A Recommended Quality System Model With Management Software

By : Alberto Sanchez

In the pharmaceutical industry, it can be difficult to find a quality system model that provides a rendezvous point to conform with the FDA's cGMP initiative, 21 CFR Parts 210 and 211 regulations, the FDA's Critical Path Initiative, ISO 9000 standards, and the requirements of foreign regulatory bodies.

The FDA, however, has created a quality systems model in the Quality Systems Approach to Pharmaceutical cGMP Regulations guidance document that can show pharmaceutical companies a high-functioning system that will help meet all of those regulations. One of the categories the document focuses on is management responsibilities, and we will discuss those responsibilities and the possibility to automate many of the associated administrative tasks.

According to the FDA's Quality Systems Approach quality system model, senior management should demonstrate commitment to developing and maintaining the quality system. The development of a quality system takes time and dedication. No matter how much a manager may know about the complexities and the "ins and outs" of various quality system models, he or she will invariably need to commit to the development of the quality system itself.

Management should be responsible (to reasonable degree) in all aspects of quality system maintenance and will often be in charge of data analysis and subsequent decision making issues. However, managers often spend most of their energy on the early stages of the quality system which are usually nothing more than tedious administrative tasks. This is unfortunate since many of the stages of quality system maintenance are prime opportunities for automation.

Quality management personnel in regulated pharmaceutical environments can take advantage of "automation benefits" by using software solutions. In short, these solutions should provide the data and trending technology that makes it easy to identify quality system deviations and nonconformance events. With effective automation technology, important responsibilities of quality system maintenance are still managed but tedious administrative can be automated.

Another responsibility for managers is to ensure that quality system plans are always aligned with a manufacturer's strategic plans. A quality system-regardless of the type-is never an entity unto itself.

It really is part of everybody's business. That is why it is essential that the quality system plans of any pharmaceutical company meet with the goals and realities of other systems and processes that occur throughout the industry.

It can be difficult, however, to align quality system management with other processes and departments (even beyond manufacturing) because departments have a natural tendency to be disjointed and subjective. An automated process will allow pharmaceutical companies to essentially connect quality, compliance and everyday procedural processes with applications that are launched from one platform.

In the pharmaceutical industry, it sometimes seems that the facets of managerial responsibilities are innumerable. However, modern quality management solutions (GxP management solutions for instance) have been designed to consolidate and considerably ease the efforts required by pharmaceuticals management personnel.

A New Paradigm to Address the High Cost of Vendor Qualification

By : Norm Howe

When FDA inspected a Heparin supplier, Shanghai No. 1 Biochemical & Pharmaceutical Co. Ltd., they thought they were seeing the real plant. It turned out that it was only a show facility. The real plant was a shadow plant located somewhere else. The US-FDA Warning Letter later stated, "The inspection revealed that the facility was not manufacturing, and did not appear to have ever manufactured, Heparin Sodium USP (or heparin sodium) for the U.S. market."

This case is similar to Baxter Pharmaceutical's experience with their Heparin supplier in 2008. The result of that deception was that hundreds of patients suffered life-threatening reactions like severe hypotension, low blood pressure and over 80 people died.

As of today there are more than 150 wrongful death cases filed against Baxter. The cost of defending itself in those suits in legal fees and employee time will be high to say the least. Even if Baxter were to win those cases, they would lose. The effort of an integrated supplier compliance program now seems small in hindsight.

Could this happen to you? How do you protect the quality of your product? What are FDA's expectations for supplier qualification? The Heparin experience shows that even an extreme onsite inspection won't necessarily reveal severe quality problems. How does one confirm that the supplier plant that you are inspecting is actually the one that supplies your company?

Some things to watch for, according to FDA, include discrepancies in date (e.g., compare when the materials arrived versus when production and testing were done) and if the facility happens to be "renovating" or "not manufacturing the day" you are there for your audit. You have to see the product being manufactured in action. You can also ask to see batch records and other documentation as proof the factory is indeed operational.

Does this solve the Show and Shadow supplier danger? No. Clearly it's not a full solution. And the fact is there is no sure solution. It's very difficult to detect someone who is determined to commit fraud. You as a buyer need to be sure that you have located the actual production facility. Fortunately these instances are rare, and most suppliers at least try to produce a quality product.

But this incident shows how critical a supplier's quality program can be. The message is that even intensive on-site audits cannot find major vendor problems. 'Show and Shadow' is just an extreme example.

Although FDA's suggestions are certainly valuable, they and all the other responses to the increasing concerns over vendor quality all seem to say one thing: more intensive audits. More intensive audits, of course, mean higher costs. And as we have seen even an intensive audit isn't guaranteed to find all the problems at a supplier. The problem is that audits are only a snapshot; a surface skim at a point in time.

Any pharmaceutical or medical device plant is a very complex place. Unless you plan to take up residence at the vendor you have no chance to understand the true nature of these operations. And what company in today's cost-cutting climate has the resources to do that? Keep in mind that an audit costs more than what you pay for your auditors to investigate the vendor. The vendor has to spend their time escorting the auditors around, digging out records, and following up on action items. Guess who has to cover that cost. The assumption today is that a BETTER audit means a LONGER audit. There has to be another way.

What's needed is a new paradigm for vendor qualification; a tool that can drill deeply into the vendor's operation at low cost; something that can provide a more lasting measure of the vendor's performance than simply an audit.

To get to the solution we have to answer this question, why don't vendors always comply with the regulations. My answer, based on years of auditing and operations management, is that by far the most common reason is lack of knowledge of the regulations through-out the organization. I'm not talking here about a general understanding of requirements. I mean a deep Knowledge of the details of how to comply with the regulations - not just that the packaging room needs to be inspected before packaging operations begin; but that previous materials have been removed, packaging and labeling materials inspected, extraneous materials removed, documentation, etc.

Sure, there is generally someone in most vendor organizations who knows the regulations. But in poorly performing companies the attitude is often that regulatory compliance is up to the Quality Department.

My proposition is that once everyone in an organization KNOWS the regulations as they apply to their jobs, DOING the job right is straightforward. The biggest hurdle to overcome is disseminating detailed Knowledge of what needs to be done to all the employees.

How can one use this relationship to assist with the problem of supplier qualification? What if it were possible to objectively measure what all the employees of a supplier know about GMPs (Good Manufacturing Practices)? That deep Knowledge plus a broad snapshot of the supplier based on an audit will give you a strong measurement of the supplier's performance.

The next question is how does one measure that Knowledge. Knowledge is not so easily measured in an audit. You can check training records. Usually you will see who sat through what training class, or who was checked off as proficient in on-the-job training. There is rarely any indication of what people actually KNOW.

So how could we effectively measure the Knowledge of all of a supplier's employees? Well, technology gives us an edge today that didn't exist not too long ago. Computer Based Training provides a reliable, and relatively cheap way to assure that all employees have a minimum skill level. Online GMP courses train and test any employee who has access to the internet. Learning Management Systems track who knows what, and make the results easily visible to management.

If you as a customer insist that suppliers test their employees and provide you with verification that all their employees have passed their GMP courses, then you can have a high degree of confidence that the supplier has the Knowledge to make compliant products. You as a customer can have independent access to the training verification reports. When your auditors cross-check the training reports against the names on batch records, the vendor suddenly becomes completely transparent.

There's another advantage when everyone in an organization is passing the same tests, peer pressure. It's not easy for one person to bypass a GMP requirement when everyone around knows that it's the wrong thing to do.

Requiring your vendor to give their employees online, verified GMP training insures that they have a deep Knowledge of the regulations. This doesn't really cost any incremental money because this is something the vendor should be doing anyway. Combining the visibility of an online Computer Based Training system with an audit can make your supplier's quality program truly transparent.

Top Ten Qualities to Look for in an Online Pharmacy

By : Amadou Moustapha Sall

As you may have noted, there are thousands or even hundreds of thousands of websites selling pharmaceutical products or drugs. These are called ONLINE PHARMACIES or PHARMACIES ONLINE.

Can they be trusted? Are they safe?

Yes, in many cases but only if you are careful and exercise your due diligence: this is all the more necessary since the consequences of cheating with pharmaceutical products can be much more serious than, for example, being conned into buying a useless fiction ebook or piece of sofware.

It can even be literally a matter of life and death.

So, here are the top 10 qualities to look for in an online pharmacy.

Go through the list carefully, use it as a filter for all the online pharmacies you come across, and you'll be covered!

1. ADEQUATE PRODUCT INFORMATION: It should be absolutely honest, say what the product does, what it does not do, side effects, incompatibilities, even... possible after-effects etc..

2. QUALITY: FDA-approved prescription drugs. Storage, Processing, Shipping must be under full compliance with US and FDA Regulations

3/4. SAFETY, SECURITY: If possible it should be accredited by bodies such as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) - "one of the most stringent and respected accrediting organizations dedicated to continuously improving the safety and quality of care provided to the public".

5. EASE OF USE: Easy ordering process, Fast delivery (Fast FedEx Delivery options, if available), Clear and Easy-to-undertstand Instructions for use.

6. DISCRETION: Discreet packaging - is it really necessary for your closest neighbor to know what was in that nice package you received yesterday :-).

7. PRIVACY AND CONFIDENTIALITY: Free consultation online: Like many people, you probably find the anonymity of an online medical consultation rather more pleasant than what could be an embarrassing conversation with your personal physician and his/her office staff.

You complete an online medical questionnaire which is thoroughly reviewed by a licensed physician, and if found suitable for treatment, the prescription will be dispensed and shipped by a licensed pharmacy.

If the consulting physician has any questions or concerns regarding your medical history or needs more information, he or she should contact you by email or by phone.

8. PRICE: Discounted, as much as possible, provided low prices does not mean low quality!

9. INTERNATIONAL ORDERS, if you do not live in the US. This should not be overlooked: Some online pharmacies only sell to customers in the US and Canada. And in some cases, they only tell you AFTER you've gone through almost the whole of the ordering process. This can be quite frustrating.

10. GOOD CUSTOMER SERVICE, including a toll free number for US residents and another number for international customers.

To be on the safe (and pleasant) side, always look for these top 10 qualities in an online pharmacy.

Online Pharmacy what you MUST Know

By : James Murray

At an online pharmacy, you can browse and shop for all the normal pharmacy items you are accustomed too, health care items, vitamins, over the counter medicines, weight loss products, diabetic supplies, and much more.

Also, at an online pharmacy, you have a choice to either visit the pharmacy (store) or have the online pharmacy fill and send your prescription through the mail. When you have your prescription drugs mailed, various pharmacies have to follow particular steps and special rules to check, fill and send your prescription drugs.

When you are at the online pharmacy website and filling out the forms with your name, address, etc. and your doctor's prescription information, they will also need a payment method to finalize the prescription order, plus any insurance payment information or medical plan you are using. Depending on which online pharmacy you use, they will either accept a payment online for delivery purposes or you will have to visit the actual store to complete the prescription payment process.

Also, one very important thing to consider at the online pharmacy your are using is that they have a secured checkout, payment system! An unsecured website will have a web address like http://www , where a secured website address will look like this https://www. The "s" at the end of "http" means it is a secured site. In future, any sites where you purchase items online make sure that this "https" configuration is in the website address, anything else can be hacked and your address, payment, and medical information stolen by Internet criminals.

Online pharmacy is the next generation of pharmacy, with the explosion of the worldwide web, every land based pharmacy will have a web presence, website, if they want to stay in business and be competitive in the pharmacy industry. When you finally select an online pharmacy website that you would like to do business with, check their site credentials, make sure that they are a "Verified Internet Pharmacy Practice WebSite" defined by the "National Association of Boards of Pharmacy." If you are concerned about the online pharmacy site and they aren't answering all your questions, there are many other sites on the Internet to choose.

One good tip about choosing online pharmacies is to select one that is associated with a large pharmacy chain, a well known pharmacy group. This way, you know the large pharmacy or someone else you know and has dealt when them before. The trust factor is minimized and your security, bank and credit information will be kept secured. "The Online Pharmacy" is the future of Pharmacy!