Ginkgo biloba: A source of Nutraceuticals Endangered

Ginkgo (Ginkgo biloba, also spelled gingko), also known as the Maidenhair Tree after Adiantum, is a unique species of tree with no close living relatives. The ginkgo is classified in its own division, the Ginkgophyta, comprising the single class Ginkgoopsida, order Ginkgoales, family Ginkgoaceae, genus Ginkgo and is the only extant species within this group. It is one of the best-known examples of a living fossil, because Ginkgoales other than G. biloba are not known from the fossil record after the Pliocene.

For centuries it was thought to be extinct in the wild, but is now known to grow in at least two small areas in Zhejiang province in Eastern China, in the Tian Mu Shan Reserve. However, recent studies indicate high genetic uniformity among ginkgo trees from these areas, arguing against a natural origin of these populations and suggesting that the ginkgo trees in these areas may have been planted and preserved by Chinese monks over a period of about 1000 years. Whether native ginkgo populations still exist has not been demonstrated unequivocally.
The relationship of Ginkgo to other plant groups remains uncertain. It has been placed loosely in the divisions Spermatophyta and Pinophyta, but no consensus has been reached. Since Ginkgo seeds are not protected by an ovary wall, it can morphologically be considered a gymnosperm. The apricot-like structures produced by female ginkgo trees are technically not fruits, but are seeds that have a shell that consists of a soft and fleshy section (the sarcotesta), and a hard section (the sclerotesta).

Kingdom- Plantae -Plants
Subkingdom- Tracheobionta Vascular plants
Superdivision Spermatophyta – Seed plants
Division Ginkgophyta – Ginkgo
Class Ginkgoopsida
Order Ginkgoales
Family Ginkgoaceae – Ginkgo family
Genus Ginkgo L. – ginkgo
Species Ginkgo biloba L. – maidenhair tree

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GMP or Good Manufacturing Practice

GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic

These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This in turn, protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.

GMP regulations address issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business.

GMP is also sometimes referred to as "cGMP". The "c" stands for "current," reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation. Systems and equipment used to prevent contamination, mixups, and errors, which may have been "top-of-the-line" 20 years ago, may be less than adequate by today's standards.

At the GMP Institute, we believe that GMP is a good business tool which will help to refine both compliance and performance at your company. GMP requirements are largely common sense practices which will help your company better itself as it moves toward a quality approach using continuous improvement. The diagram at left illustrates how we approach creating and maintaining a GMP lifestyle in a company. First, set standards of performance. These include GMP regulations and other standards which are necessary for your company. Then, train to those standards. All departments in the company should be trained (to varying degrees) on GMP and other standards. The diagram lists four types of employees which are especially critical to train: top management, managers and supervisors, operators and technicians, and support staff. Because training is such an important part of maintaining a GMP Lifestyle, the GMP Institute focuses heavily on training. We offer many workshops for a variety of types of people. GMP 101 is a great introduction to the concepts of GMP and the reason behind it. Additionally, we offer workshops to help in house trainers perfect the art of training, and to help them learn how to make GMP an interesting topic. We even offer a certification program for trainers.

The next step in the GMP Lifestyle is to reinforce what was learned in training. This falls on the managers and supervisors in a plant. Therefore, it is important that managers and supervisors be involved in training, so that they can support it through reinforcement. The same four job categories are listed as being the most critical in promoting and receiving reinforcement.
The third stage is to audit to ensure that your efforts have provided adequate controls by auditing. Audits fall in the following three categories: personal, whereby every individual does a self-check to make sure that he/she is complying with all appropriate standards; internal audit, which should be performed by the quality assurance department as required by GMP, and external audits, which can consist of an FDA audit, a consultant checking your compliance status, or you performing a supplier audit. The GMP Institute also offers workshops for auditors needing training.

Finally, the results of audits will help you to know if you need to modify your standards of performance. Of course, no procedures should be changed without appropriate change control and approval from quality assurance. The glue that sticks the whole process together is commitment. Commitment to GMP and quality is critical at all levels of the organization, starting with top management. If you foster commitment, use this process, and attend GMP Institute workshops when necessary, you will help you make GMP a Lifestyle, Not Just a Regulation in your company. You will then improve the overall performance of your workforce, as well as your FDA compliance.

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Good laboratory practice or GLP

Good laboratory practice or GLP generally refers to a system of management controls for laboratories and research organizations to ensure the consistency and reliability of results - as outlined in the Organisation for Economic Co-operation and Development (OECD) Principles of GLP and national regulations.

GLP applies to non-clinical studies conducted for the assessment of the safety of chemicals to man, animals and the environment.

Good Laboratory Practice (GLP) embodies a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. These studies are undertaken to generate data by which the hazards and risks to users, consumers and third parties, including the environment, can be assessed for pharmaceuticals (only preclinical studies), agrochemicals, cosmetics, food additives, feed additives and contaminants, novel foods, biocides, detergents etc.

GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments.

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What are the Benefits of Ginseng?

The Chinese people have used ginseng in herbal medicine for centuries. Rhizomes resembling the human form are thought to be more valuable medicinally. Ginseng rhizomes contain substances called ginsenosides, a class of chemical compounds responsible for its anti-inflammatory, antioxidant, and cancer preventing properties. Ginseng is used to cure the entire body and is not used for a specific organ or body part.

Check with your doctor for contraindications before using ginseng products. There may be adverse effects such as insomnia, headaches, uterine bleeding, or diarrhea if ginseng is consumed over a period of time or with other medications. Ginseng is also considered to be a stimulant, so caffeine and other stimulants should be avoided when using ginseng.

Studies show that ginseng is a non-toxic herb, although as with any herb or medicine, avoid excessive or prolonged use. The recommended dosage is 0.5 to 2 grams of rhizome per day, the equivalent of approximately 1 to 5 thin slices of rhizome. Ginseng should not be used for more than three consecutive months without a 2-week break from use.

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How to make Ginseng Tea

Ginseng tea is slightly sweet at first but may have a strong biting or even bitter aftertaste. It is often mixed with chrysanthemum tea and sweetened with sugar or honey.

The first method for making ginseng tea is to pour boiling water over 3 to 5 thin slices of ginseng and let steep for 5 minutes—more if you prefer stronger tea, less if you prefer weaker tea.

Alternatively, boil 3 cups of water, add 8 to 10 ginseng slices, and then simmer for 15 to 20 minutes. Strain and let cool. It can be served warm or cold as an iced ginseng tea. Store the tea in the refrigerator.

Or, try the Korean version of ginseng tea. Place thinly sliced pieces of ginseng rhizome in a ceramic, glass, or stainless steel bowl and add a few teaspoons of honey. Let sit for 30 minutes, and then pour boiling water over the mixture to make the tea.

Tea can also be made with liquid extract or ginseng powder. For liquid extract, mix one cup of extract with one cup of boiling water. For powder, dissolve 1 teaspoon in one cup of boiling water.
It is also possible to use a standardized extract to make tea by adding a few drops to hot water in a cup. Be advised that extracts may contain small amounts of alcohol unless otherwise stated.

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