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What are the Manufacturing Principles for the Therapeutic products in Australia?

The Therapeutic Goods Administration (TGA) currently licenses the manufacture of medicinal products in Australia in accordance with the Australian code of Good Manufacturing Practice for Medicinal Products (dated 16th August, 2002). On the 29th July 2009, the Australian government legislated the implementation of a new set of manufacturing principles under the Therapeutic Goods (Manufacturing Principles) Determination No.1 of 2009. This determination (with some minor exceptions) effectively replaces the current code with the Guide to Good Manufacturing Practice for Medicinal Products (PE009-8) (dated 15th January, 2009) published by the Pharmaceutical Inspection Co-operation Scheme (PIC/S)

The updated principles are scheduled to become mandatory for all manufacturers of medicinal products (who are subject to the TGA) one 1st July 2010. In the interim, the TGA will accept compliance with either the existing manufacturing principles, or the updated principles.
Table 1: Implementation dated for the Therapeutic Goods (Manufacturing Principles) Determination No.1 of 2009 Date Active TGA code of GMP for Medicinal Products Prior to 29th July 2009 Australian code of GMP (AUG 2002) 29th July 2009 to 30th June 2010 Australian code of GMP (AUG 2002) or PIC/S Guide to GMP (JAN 2009) 1st July 2010 PIC/S Guide to GMP (JAN 2009).

What does GMP stand for in the pharmaceutical industry?

GMP (Good Manufacturing Practice) is used internationally to describe a set of principles and procedures which, when followed by manufacturers of therapeutic goods, helps ensure that the products manufactured will have the required quality.

What do the Aust R and Aust L numbers mean?

They show that the medicines are accepted by the Therapeutic Goods Administration for supply in Australia and are included in the Register. The number is printed on the outer packaging so that it can be seen easily

AUST R medicines are assessed for safety, quality and effectiveness. The include all prescription only medicines and many over-the-counter products such as those for pain relief, coughs and colds and antiseptic creams.

Prescription only medicines do not display their purpose on the label as the decision for using them lies with a doctor; however, over-the-counter medicines must have a purpose displayed.

AUST L medicines can only contain pre-approved low-risk ingredients. They are used for minor health problems and are reviewed for safety and quality. They include sunscreens over SPF4 and many vitamins, mineral, herbal and homeopathic products. A purpose must be included on the label.

What is the Marketing Authorisation issued by TGA Australia?

The marketing authorisation is the approval or authorisation given to the sponsor by the TGA to supply a therapeutic good in Australia. The marketing authorisation includes the formulation listed on the ARTG (for listed products) and shelf life conditions together with any other conditions of listing or registration.

What is the key information on the product labels?

Important information relating to the quality and safe use of the product must be on container labels and the outer packaging. You should read this information and closely follow any directions.

This information includes:
if the product is included in the Australian Register of Therapeutic Goods. Access to ARTG SEARCH enables consumers to view product information such as Sponsor and Manufacturer, medicine formulation details, label claims and other information.

Labels must show how to store the product such as "Store below 30°C which in most parts of Australia means room temperature. Some medicines must be stored in a refrigerator.

This is similar to the use-by date on food products at the supermarket. The medicine should not be used after this date because it can lose its effectiveness or become unsafe.

The batch number and name and address of the supplier must be on the labels and can used to trace the medicine if a problem is found.

Product Information:

What is the meaning of "Halal"?

Halal is an Arabic word meaning lawful. It refers to things or actions permitted by Islamic Shariah law without punishment imposed on the doer. It is usually used to describe something that a Muslim is permitted to engage in, e.g. eat, drink or use.

Are all the health supplements Halal products?

Not all the health supplements are Halal products. Products containing such as a deer, kangaroo, ovine, emu and bovine collagen would not been approved to adopt Halal compatible manufacturing process.

What is soft gel capsule made of?

Gelatin used for used for soft gels comes from animals, specifically the collagen from connective tissues, bones, sinews and skin. These are extracted from the byproducts of the meat and leather industries, and usually consist of the skin or bones of cattle and pork.

Why do the soft gel capsules sometimes stick together and are difficult to take out from the bottle?

Heat, humidity, and sunlight could cause the soft gel capsules to stick together. This could happen on the every product in soft gel form such as fish oil, Lecithin, Garlic oil if stored in improper conditions. Product should be placed in a dry cool are under 30°C as advised on the product labels.

What is Essential Fatty Acid?

There are three types of essential fatty acids: Linolenic Acid (?6). They are function as essential building blocks in every membrane of every cell in your body, keep beneficial substance within your cells and harmful ones out. Both Omega-6 and Omega-3 are necessary in our diet because our body cannot make them, yet we use them to make many other fatty acids through our diet where they naturally occur in vegetable and fish sources. Both of these groups of essential fatty acids provide a ready source of energy and are used by the body to make 'Prostaglandin', which are regulators of numerous body processes.

Sources of Omega-3 include:
• Fish Oil, Flax Oil, Pumpkin Seeds, Oysters, Wheat Sprouts and Leafy Greens.

Sources of Omega-6 include:
• Evening Primrose Oil, Lecithin, Starflower Oil, Spirulina, Breastmilk, Flax Oil, Raw Nuts, Sunflower Seeds and Leafy Greens.

How much Calcium do I need to take every day?

The Recommended Daily Intake for calcium from all sources (foods and supplements) is 800mg, except it rises to 1000mg per day during menopause.

To maintain peak bone mass the adult daily calcium intake should be approx. 1000mg. NOTE that in the nutritional supplement business the term "elemental calcium" refers simply to "calcium". The market leader "Caltrate" has Calcium 600mg with the recommendation of 1 or 2 tablets daily ie. 600/1200mg mg/day. Caltrate uses the calcium carbonate form (2.5:1) input 1500mg equals 600mg - 2 tablets daily. Irrespective of what form is used they are all expressed as being "equivalent to" Calcium"mg. In the case of our Calcium product, we use calcium citrate and the input ratio is 4.8:1 - 1116mg calcium citrate equals 250mg × 4 tablets daily = 1000mg.

Various forms of calcium are used in products - calcium carbonate, calcium orotate, calcium citrate and calcium amino chelate.

Originally our Calcium Formula (250mg calcium) recommended only 1~2 tablets daily and this was changed in 2004 to 2~4 tablets daily (1000mg) to include the menopause claim. Without the menopause claim our 500mg per day was quite an acceptable supplement level.

What is the form of Calcium?

We elected to use a Calcium Citrate form of calcium as this form is better assimilated in an acidic environment. Some people, especially the elderly, many have depleted Hydrochloride Acid levels which would impair calcium absorption. To assist with this problem we used the Calcium Citrate formula which has an acidic pH balance.

Our Calcium Formula includes Vitamin D which aids proper assimilation and utilization of calcium and nutrients including Zinc and Magnesium which assist with the body's uptake of calcium.

How much nutrients can people absorb from supplement products?

Absorption rate of supplement products varies from one product to another. As these products supplement the nutrients that are naturally occurring in the foods we eats the rate of absorption will be controlled by those foods, together with the actual quantity of the supplement utilized by the body. Generally the best time to take supplements is usually after meals because the supplement is absorbed better when it is combined with other food. Vitamins and minerals work most effectively when they are taken at regular intervals throughout the day.

Minerals are necessary for the proper absorption of vitamins, so these should be taken together at the same time. As most supplement products are short acting - a period of up to 6 hours - we would indicate that total 100% of the active is absorbed over that period. Non actives (excipients) also during this time.

Examples: For those vitamins that are fat soluble - Vitamin E example - the total mg strength is absorbed into the GI Tract and any that is not used immediately by the body is stored by the body in fat tissues for later use. Vitamin A, D and E (all fat soluble) should be taken with food to ensure complete absorption. The water soluble vitamins, especially Vitamin B complex and Vitamin C are removed quickly from the body and breaking the dose into three parts to be taken after a meal will give the best chance for keeping high levels of the supplements in the system.

Vitamin B Complex - take first thing in the morning for greatest efficiency.
Vitamin C - most effective with meals and this is the safest should the person have an acid sensitive stomach. When taken in the morning, often an increase in energy levels has been reported.
Multivitamin, antioxidants and minerals - taken anytime is effective and safe.
Calcium - absorption is enhanced by taking it with other nutrients, so with meals may be far more effective.
Zinc - take with meals, can cause nausea if taken with insufficient food.
Magnesium - can promote sleep so it is best taken at night.

Time release formulas (long acting) need to be taken with food because their nutrients are released over time. The food in the system will slow down their passage so that they can be absorbed at the sites within the gastrointestinal tract that suit them best.

It is suggested that these supplements should be taken with the main meal of the day.

What is Royal Jelly?

Often known a bees' "milk", royal jelly is the concentrated super food responsible for turning an ordinary worker bee into a Queen Bee. 50% larger than worker bees, she lives 4 to 5 years, compared to other bees that only live through one season.

Why is Royal Jelly important to health of human being?

Royal Jelly (along with bee pollen, propolis and honey) contains a natural source of nutrients which the body needs to maintain good health. Maintaining good health is especially hard in today's increasingly toxic environment. Both our food supply and our diet are often deficient in important nutrients. Therefore, we need to supplement our diet with products such as royal jelly and the other products of the beehive.
bee pollen
The main actions of freeze-drying Royal Jelly are same as fresh royal jelly. For Example:
1. Promote metabolism, and strengthen organic functions.
2. Lower cholesterol, stimulate ,myocardium, and accelerate blood circulation.
3. Regulate enzymatic secretions of endocrine glands, and ease internal digestion.
4. Speed up the works of fats, protein, saccharine metabolism and internal absorption.

What ingredients in Royal Jelly do people pay much attention to?

Besides protein, mineral, amino acid, and vitamins, the Royal Jelly contains 10-hydroxy decenoic acid and protein. Royal Jelly tastes sour because it contains 10-hydroxy decenoic acid.

This acid can inhibit the bacterial growth. It also has the function of anti-cancer. Consequently the medical scientists pay much attention to it. Protein is a stimulator from salivary gland. It can revitalize the cell metabolism and revitalize the old cells. The vitamins contained in Royal Jelly are mostly vitamin B group.

How to choose a qualified Royal Jelly capsule product?

There are many companies importing bulk royal jelly products that have been capsulated. These products can be sold inexpensively, however, they are sometimes unregulated that could be harmful to your health eventually.

Royal Jelly is a volatile substance and it needs to be handled and processed correctly. It needs to be processed within 1/2 hours of leaving the beehive. It then needs to be checked for contaminants and potency directly before encapsulation.

Capsulated royal jelly product from import bulk cannot be checked for potency and contaminants as it is already in capsule form. It is not uncommon for the product to contain much less active ingredient than is stated on the label, with the product weight made up by fillers and chemical preservatives.

That is why you should choose royal jelly products from companies whom you can trust, preferred companies that process their royal jelly locally an do so in licensed and regulated facilities, according to GMP standards to ensure all its nourishment and benefits 'locked-in' for the duration of its shelf life.

Tip: Always insist on - No Chemicals, No Preservatives, Maximum freshness.

What causes the colour change of Royal Jelly capsules from milk yellow to brown?

Royal Jelly fill material in the clear soft gel capsule is yellow giving the capsule its opaque appearance. Royal Jelly in amongst other things contains sugars and protein. The capsule shell also contains protein. Over time a natural reaction occurs between the protein (amines) and the sugars of the Royal Jelly as well as between the protein of capsule shell and the sugars of the Royal Jelly. This reaction leads to the "browning" of both the Royal Jelly and capsule shell leading to a capsule which appears brown rather than its original opaque yellow. This is a natural reaction which manifesting itself visually. No loss of potency or quality results.

What are the benefits of Squalene?

Squalene is an oily substance that easily absorbs oxygen and is presumed to help deliver oxygen throughout the body to the cell tissues that need it. It is an extremely safe product for human ingestion, will not irritate the eyes, broken or intact skin.

1. is beneficial for patients with heart disease and arthritis (by easing joint pain and inflammation).
2. is recommended for people who suffer from gastritis.
3. can normalize blood cholesterol levels in people who consume a lot of fatty foods.
4. helps the skin get the nutrients it needs, and can provide you with a healthier looking complexion.
5. may by used as general health tonic for hard working people.

Where does Squalene come from?

Main source is from deep sea cold water sharks. Squalene is purified poly-unsaturated hydrocarbon liquid and is produced in large quantities by the liver of deep sea sharks. These creatures live at ocean depths of 1800 - 6000 feet. Squalene is a source of energy for the sharks and it allows them to live at these depths, and thrive in an environment that is harsh and oxygen free. Squalene is not found in sharks living at shallow sea levels.

The human body tissue also contains small amounts of squalene, however it occurs in shark liver oils as a major component, comprising of up to 85% of the oil. Squalene is also found in small quantities in olive oil, rice bran and yeast. It is unique oil, high in Vitamins A and D that is found in high concentrations within shark liver.

Why is honey a bit sweeter than ordinary table sugar?

Honey gets its sweetness from the monosaccharides fructose (fruit sugar) and glucose and has approximately the same relative sweetness as that of granulated sugar (97% of the sweetness of sucrose, a disaccharide). Some people think honey is a bit sweeter than ordinary table sugar because honey has a lot of fructose that's sweeter than sucrose. These simple sugar that honey contained does not need to pass through the digestion to be possible by the human body absorption. They are especially good for the elderly and have been referred to as "the elderly milk". However, honey should not be fed to infants younger than 1 year old because clostridium bacteria that cause infant botulism usually thrive in soil and dust.

A couple of years ago there was a media scare that imported honey (mainly from China and Argentina) was contaminated with antibiotics called nitrofurans, which were now prohibited in Australia/

People may notice the latest news alarming on the problem of the disappearing honey bee due to perhaps global warming. It is now estimated that nearly 70% of the worldwide bee population died in the past years. The bee epidemic has hit every country in the world and has affected not only the quantity of production but also the quality of honey products. Regular consumers should concern if the honey you take have been added artificial sugar or sweeteners for the purpose of cost down or better taste to fit market requirement due to the above situation.