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The objective is cost effective manufacturing

There are key elements to becoming a cost effective manufacturing team.  Managers should be armed with the right tools to guide the productivity and optimization. Their teams should be prepared to react to common problems in the manufacturing environment. Employee performance is the key to holding it all together or seeing the process fail. Effective learning techniques pinpoint key avenues to solving defects and increasing productivity. A simple, yet effective key to managing people is to help them learn. The challenge is that the learning curve is a variable that changes from employee to employee. Repetitive and consistent reinforcement is the key to enhancing the knowledge base rapidly and effectively.  Not everyone is willing to admit that they do not comprehend subjects or learn as quickly as their peers, and guessing and assuming leads to trouble.  Training the trainers has its limitations and trainer burn out is a real and significant issue.  The demand on the manufacturing floor is to understand and follow SOP’s (standard operating procedures) while employing a GMP (Good Manufacturing Practices) mentality.  These requirements must be balanced with equipment function and reliability to ensure everything is in good operating condition and ready to perform.  The single most effective key is having a learning system that combines SOP’s, batch records, theory, and actual employee function with a swat team approach.  The learning system must be a single source and not be effected on the trainer having an off day, poor attendance, lack of trainee comprehension, or interruptions.  The ideal scenario would be a learning station that can be used in a training room or on the production floor.  This system could be used to review a procedure, provide self evaluations, and document employee comprehension and performance.  This is the most effective way to achieve Cost Effective Manufacturing.

Posted by Mike on March 5th, 2010 :: Filed under Blending, Certification, Formulation, Invitation & Objectives, On line seminars, Production, Tableting, cGMP's, granulating

If you make it, they will come!

They being the FDA that is… If you manufacture, package, or label drugs or dietary supplements, you will see the FDA at some point. I have had clients who didn’t think they had to comply if they manufactured the products but someone else packaged and labeled them. I’ve had the opposite too where someone who bought bulk tablets and capsules, then packaged and labeled them didn’t think they needed to comply because they were not manufacturing them. Well, both companies need to comply!

Typically, GMP inspections take place every two years. Drug companies are used to seeing the FDA, but Dietary Supplement companies are new to this. Just to refresh everyone’s memory, supplement companies with more than 500 employees had to be in compliance with the supplement GMP’s, 21 CFR Part 111, by June 25th of 2008. The FDA has been out inspecting these companies and several EIR’s, along with their 483’s are on the FDA’s website. Go to http://www.fda.gov/AboutFDA/CentersOffices/ORA/ORAElectronicReadingRoom/default.htm You’ll need to navigate through them to find the supplement ones, but there is some interesting reading there.

This past June 25th, companies with 20-500 employees had to be in compliance with Part 111. A couple of my clients have already seen the FDA at their facility so that’s proof that FDA is out on the job. So, anyone that didn’t think this was real or that FDA wouldn’t be able to get these inspections done, think again! As I said earlier, if you make it, they will come.

Next June 25th, companies with fewer than 20 employees hit their compliance deadline. My hope is that every company making supplements reads the regulations, apply them to their organization, and be ready when the FDA shows up at your facility.

If you are wondering if you are ready or not, no worries! Techceuticals can definitely help. Contact me at carol@techceuticals.com or give me a call at 843-815-7441 and I will be happy to help answer your questions and provide you with the help you need.

Until next time, have a quality day!

Carol (Brennon) Tousey, ASQ CQA

Posted by Mike on October 2nd, 2009 :: Filed under cGMP's
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Confused about Raw Material Identification Requirements?

I understand there is still a great deal of confusion surrounding the Raw Material Identification requirements in the Dietary Supplement GMP’s. I hear from clients daily that they still don’t know what to do, how to do it, and when to do it. Let’s see if we can help clear up some of the questions folks are having out there!

First off, let’s review the regulations so we know why ID testing is required. According to 21 CFR Part 111, Subpart E, 111.75, “before you use a component, you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient” What that means is that for every unique lot of incoming dietary supplement ingredients, you will need to conduct at least one test or examination that will confirm the identity of that material before use approve it for use and use it in manufacturing.

Let’s be clear about the unique lot of incoming components before we move on. Let’s say you receive a shipment of Vitamin C. You ordered 500 kilograms of Vitamin C and the shipment arrives at your dock. When you do your receiving inspection, you have 2 50 kilo boxes of lot#A360, 4 50 kilo boxes of lot#B720, and 4 50 kilo boxes of lot#A470. To comply with the regulations, you would need to conduct your identity test of a sample from lots A360, B720, and A470, so you would need to do three identity tests on this incoming shipment because it contains three different lots of material, even though it’s the same material, received at the same time. Its always a good idea to request that your order be filled with one lot of material whenever possible.

Now that you’ve ID tested those three lots, the next time you get a shipment of Vitamin C, it has two lots; A470 and C220. Provided you have it written in your inspection SOP correctly, you would not need to ID test lot A470 again since you’ve already tested it, but you would need to test C220. Make sense?

The next thing to look at is how to do the ID testing. Since no one test or examination will give you all the identity information you need, you really have to know your materials well to specify what test or examination you will do. I once talked with a client who was struggling with how to test one of his incoming materials. He used broccoli in one of his powders. Yup, raw broccoli! He bought fresh broccoli, dehydrated it, then ground it into a powder and used that in his product. We made the examination simple - if you have raw broccoli, a visual and organoleptic test will definitely identify the material as broccoli since nothing else will look and taste like raw broccoli. If he were to buy the broccoli all dried and powdered, then his test would be different. Then he would need a more complex method like FTIR, HPLC, or some other way to detect the chemical markers that provide broccoli’s unique fingerprint. You must spend the time to get to know your materials well so that you can pick the test or examination that will provide you with certainty that the material is in fact what it needs to be. That may be an HPTLC test or it could be a simple microscopic analysis. The thing is, you get to decide what the test is, as long as you can show it is scientifically valid and will provide you with verification that the material is what it says it is. The regulations state that you can use, “gross organoleptic analysis, Macroscopic analysis, microscopic analysis, chemical analysis, or other scientifically valid methods” so as you can see, you have the ability to be creative with your identity testing. Just be sure whatever method you decide to use provides you with verification that the material is what it needs to be.

I’ll give you another example, back in my manufacturing days, the company I worked for used Zinc Oxide as an active ingredient for an OTC drug product. All OTC ingredients need to be identity tested also. The USP listed several different ways to identify this material. One of them was that when heated strongly, zinc oxide would turn from its original white powder form to a yellow powder, then return to white when cooled. I could have sent the material out for IR testing or another form of chemical analysis, but instead, we specified that heat test as the ID test and it worked. It was scientifically valid, fast, and provided verification that the material was in fact what it needed to be. So you see, you can use a test that may seem too simple, but gives you the information you need. But you MUST spend the time getting to know your materials well first!

I hope this helps answer some of the questions out there.

Carol Brennon, ASQ CQA

Posted by Mike on June 25th, 2009 :: Filed under cGMP's
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