Newsletter LabialfarmaNewsletter n˚6 | March 2012

The Labialfarma’s QualityPolicy

LABIALFARMA’S MARKETING AND COMMUNICATION DEPARTMENT

QUALITY ASSURANCE FOR THE MANUFACTURE OF PRODUCTS BASED ON PLANTS

Products based on plants are produced with, mainly, entire plants, fragmented plants, parts of plants, algae, fungi, without any treatment, normally in a dry form, but sometimes in fresh form. Some exudates, which have not been subjected to special treatment, are also considered vegetable drugs.

DR. HELTON SANTOS’ EDITORIALIN THE INTERNATIONAL PHARMACEUTICAL INDUSTRY MAGAZINE

Dr. Helton Santos, head of our Department of Pharmaceutical Development, writes about “Manufacturing and Quality Control of Liquid-Filled Two-piece Hard Capsules” in the International Pharmaceutical Industry Magazine editorial.

As a result of the need of developing an organizational strategy communication towards our clients, promoting and targeting products, services, benefits and solutions, the new Marketing and Communication Department has became operational since early this year.

The Labialfarma´s Mission is to contribute to the health and well-being of people through innovative and quality manufacture of nutraceuticals and pharmaceutical.

FDA – Food and Drug Administration, it’s the United States of America governmental

agency responsible for the regulation and supervision of medicines, food supplements, cosmetics, medical equipment, biological material and other materials of public use. Any new medicine, food supplement, cosmetic and all the others that are under its supervision is thoroughly tested and studied before it has the commercialization approved.

LABIALFARMA GETS A FDA REGISTRATION IN USA

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LABIALFARMA gets a FDA registration in USA

FDA – Food and Drug Administration, it’s the United States of America governmental agency responsible for the regulation and supervision of medicines, food supplements, cosmetics, medical equipment, biological material and other materials of public use. Any new medicine, food supplement, cosmetic and all the others that are under its supervision is thoroughly tested and studied before it has the commercialization approved.

Labialfarma SA, has assumed throughout its existence a strong and permanent philosophy in the Quality and Innovation in its products and services.

In a solid investment in the most recent areas of production and in the most modern equipment, Labialfarma has shown a special attention in the selection and training of its Technical Boards.

Its recent line of Soft Capsules production, the only one in Portugal, has been highlighted as strategic business unit, thanks to the equipment that has been selected and the recruitment of foreign specialized technicians with a recognized experience in this sector.

Of the many reasons that exist for a company to decide to implement an Efficient System of Quality Management, Labialfarma SA based its bet in a diligent pursuit of the Highest Quality, whose excellence is the complete satisfaction of its customers.

Linking the increase in Quality to a strong innovation component, Labialfarma SA, today it’s a strong company with a high capacity in Investigation & Development of products with a high added value, enabling to its clients a differentiator against its competitors.

It was in this way that Labialfarma SA, advanced to the FDA – Food and Drug Administration, registration process, an important recognition for the company and for all its Clients.

FDA – Food and Drug Administration, assigned to Labialfarma SA, the following registration number:

In order to continue the relentless pursuit of quality at the level of excellence, we reaffirm our spirit of partnership that ennobles for decades the relationship with You all.

Thank you very much .

CERTIFICATE OF REGISTRATION Nº 11763556600

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Eckart Wintzen

“Connecting computer is a work. Connecting people is an art.”

As a result of the need of developing an organizational strategy communication towards our clients, promoting and targeting products, services, benefits and solutions, the new Marketing and Communication Department has became operational since early this year.

Efficient communication is fundamental to establish a fresh image of the company, based on its corporative identity, represented by its products, services, benefits and solutions.

Integrated marketing communication is also indispensable to the success of B2B strategic plans.

Based on this philosophy, we can highlight the followed functions of the Marketing and Communication Department:

Nowadays it’s really important to assume an online presence -since the company value is measured not only by incomings and profits but also by the value that a brand assumes when facing the market (either online or offline).

Due to the constant innovation of the communication technologies and newest ways to communicate, one of the top priorities of this Department is to include Labialfarma in the nowadays social and professional networks, to assume a timeliness role that follows the philosophy transmitted to us every day.

Online presence

We can find Labialfarma already in the social/professional network Linkedin:

http://www.linkedin.com/company/labialfarma

This way, when anyone changes the place of work, the connection is made directly to the company profile.

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Identify and satisfy the client needs;

Develop and manage a (outside and inside) communication control system;

Promote Labialfarma’s distinctive characteristics;

Intensify the relationship with the clients.

Labialfarma’s Marketing and Communication Department

The Labialfarma´s Mission is to contribute to the health and well-being of people through innovative and quality manufacture of nutraceuticals and pharmaceutical.

This is the reason for our existence - Labialfarma wants to be recognized now and remembered in the future.

Ao mesmo tempo que realiza a sua Missão, a LABIALFARMA tem já uma ideia daquilo que quer ser no futuro, ideia esta expressa através da sua Visão.

At the same time Labialfarma carries out its mission and has an idea of what wants to be in the future. This idea is expressed through its Vision. Thus, Labialfarma intends to be a reference on how to manage its business processes - by competence and involvement of its employees - and also, how to turn its activities into opportunities for innovation.

In order to accomplish its mission, Labialfarma has as pillars, the values in that we believe. We mean:

Based on the realization of its Mission, Vision and Values, Labialfarma undertakes to:

This set of themes - Mission, Vision and Values - and commitments enshrined, is the Quality Policy of Labialfarma, a document that serves to guide the company. Thus, Labialfarma defines a set of guidelines for all processes and activities, with consequences for the quality of products, which must be understood and followed by all employees and which are communicated by Labialfarma to all stakeholders - customers, suppliers and society in general.

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Ethics: Acting with transparency, accuracy, professionalism, truth and loyalty.

Responsibility: Social, Economic and Environmental.

Innovation: Promoting innovative products and services that meet the needs of our customers.

Excellence: Skills, high level of demand in the performance of the activities, effectiveness, efficiency, and continuous improvement.

Learning and Development: Motivation and valuing employees.

Fully satisfy the needs of its customers, providing them products and services of high quality, exceeding their expectations;

Establish and maintain a management system that ensures the improvement of the processes of its value chain, and to ensure compliance with the requirements of GMP (Good Manufacturing Practices / Good Manufacturing Practice) and HACCP (Hazard Analysis and Critical Control Points);

Motivate and encourage the employees, a prerequisite for the growth;

Develop partnerships with the customers and suppliers, involving them in our activities;

Continuously improve our management system.

The Labialfarma’s Quality Policy

Only recently, LiqFillCaps developed and validated a system capable of ensuring a nitrogen-saturated environment at the liquid container and, most important, at the liquid-filling station of a LIQFILsuper40 (Shionogi Qualicaps).

The system developed by LiqFillCaps was able to decrease oxygen in the head space of the liquidfilled hard capsule to values below 5% depending on the nitrogen purge. For that purpose, the oxygen and nitrogen levels were measured using a needletype oxygen microsensor suited for measuring oxygen distribution profiles.

This nitrogen purge system for the liquid-filling of hard caps was shown to be essential when a highly sensitive to oxidation oil was filled into two-piece hard gelatin capsules.

Measurement of the oxidative parameters (peroxide value and p-anisidin value) for the filled oil, with and without the nitrogen purge system, was compared.Evidence showed that the oxidative parameters were kept low and constant throughout the stability study under ICH conditions when applying the nitrogen purge system.”

Dr. Helton Santos, head of our Department of Pharmaceutical Development, writes about “Manufacturing and Quality Control of Liquid-Filled Two-piece Hard Capsules” in the International Pharmaceutical Industry Magazine editorial (2012, Volume 4, Issue 1).

Below is a short reference to the mentioned editorial:

(…)

“The technology for obtaining two-piece hard capsules filled with a liquid or semi-solid formulation is relatively simple. The production of the dosage form is carried out in appropriate facilities with specialised equipment, under suitable and controlled conditions of temperature and humidity. Basically, the manufacturing process includes multiple steps, namely content preparation, filling, sealing or banding of the filled two-piece hard capsules, followed by drying of the sealed/banded filled two-piece hard capsules. The process for the production of liquid-filled two-piece hard capsules is also simpler as compared with that used to obtain soft gelatin capsules and, regarding the filling of powders, the problems of weight variation are reduced, and cross-contamination is virtually eliminated.

The mentioned regulation has a list of endangered species where there can be found, as an example, Panax ginseng grown in the Russian Federation.

Labialfarma has a careful selection process for all the raw materials, and, therefore, uses only Panax ginseng that is not originated from the Russian Federation, ensuring the compliance of the above Regulation and contributing to the protection of endangered species.

Camellia sinensis, a plant used as an ingredient of the Energytea Wellcare (page 8), is not considered to be an endangered species, and therefore, is not covered by the Regulation (EC) n.º 407/2009.

Labialfarma’s Regulatory Affairs check to ensure that all species used in our products are in accordance with the Regulation (EC) n.º 407/2009.

Did you know that…An endangered species is, by definition, a dead or alive animal/plant, used in the Community or in international trading activities, threatened of extinction or so rare that any level of commerce might compromise the survival of the species.

Accordingly, it was established the Council Regulation (EC) n.º 407/2009 of 14 May 2009, that changes the previous Regulation (EC) n.º 338/97 of 9 December 1996, with the purpose of ensuring the survival and protection of fauna and flora by the regulation of its trade.

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Dr. Helton Santos’ editorial in the International Pharmaceutical Industry Magazine

Chamomile, passionflower, lime blossom, orange blossom and St. John's wort are examples of plants which, when consumed as herbal teas, have properties that can help relieve insomnia.

There are other active ingredients that can be used to improve quality of sleep such as valerian, passionflower, hop, chamomile, among others.

Sleep is essential for physical and psychological recovery. It is prompted by cycles of activity in the brain and consists of two basic states: Rapid Eye Movement (REM) sleep - when most sensations occur - and Non-Rapid Eye Movement (NREM) sleep. NREM consists of stages I through IV: stage I, is a light stage of sleep; stage II, a slightly early stage of sleep; stages III and IV, are deep sleep stages. Most of stage IV sleep occurs during the first hours of sleep.

Sleeplessness or insomnia are symptoms which can be caused by: stress, anxiety, depression, illness, pain, medication, sleep disorders, poor sleep habits and unhealthy habits. Transient insomnia is very common and usually lasts a few days.

Chronic insomnia lasts for more than three weeks and can result in serious consequences, affecting our physiological and emotional balance:

Wellcare herbal teas:

Description:

Melatonin is a hormone secreted by the pineal gland, located in the base of the brain. It helps regulate sleep and may play a role in maintaining human circadian rhythm, an internal 24-hour clock. The hypothalamus receives information about the amount of sunlight that enters through the eye, and when sunlight decreases, more melatonin is released by the pineal gland, promoting sleep.

Medical use:

Several medical uses have been reported for melatonin, but its current popularity is based on its use as an aid to sleep and overcome jet lag. Nevertheless, specialists warn that the natural production of melatonin declines with age, and this aggravates sleeping disorders.

According to statistics, about half of adults in developed countries suffer from occasional sleep problems or chronic sleeplessness, at some point in their life. Melatonin supplements became popular through the 1990s as a treatment of insomnia. The second most popular use of melatonin is to attenuate the effects of jet lag, a physiological condition caused by alterations to the body's circadian rhythms resulting from long-distance transmeridional flights (east–west or west–east). Melatonin can be taken as dietary supplements, daily dosage up to 2 mg.

Melatonin

Insomnia is the inability to consistently sleep well in quantity and quality. The difficulty may lie in falling asleep, in maintaining a continuous sleep, or both. Insomnia is a common symptom that affects millions of people and can derive from numerous disorders, diseases or conditions.

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Increased irritability and decreased patience, which may deteriorate personal relationships;

Increased stress;

Decreased attention and lack of concentration;

Fatigue;

Drowsiness;

Increased probability of developing diseases such as anxiety, depression, among others.

Insomnia

Liposanol™

Liposanol™ is a natural ingredient, rich in polyphenols, chlorogenic acid and quercetin, aimed at promoting weight loss.

1- Reduces the absorption of calories, by inhibiting the absorption of glucose, intestinally (binds to receptors of glucose transporters)

2- It helps to regulate blood glucose

3- It has a venotonic action and promotes microcirculation activation.

4- Inhibits fat storage in adipocytes

Mechanism of action

Carbograss™

It is a water soluble polymer similar to cellulose, with the ability to absorb fats, derived from shellfish.

Its intestinal absorption is minimal, being essentially excreted in the feces.

Its action in lowering cholesterol associated with low density protein (LDL), increase in cholesterol associated with high-density proteins (HDL) and reducing weight is made possible by binding of positively charged amino groups to negatively charged molecules (derived from fatty acids and bile acids), preventing their absorption.

Mechanism of action

Why buy multiple products for the same purpose: lose weight?

With the new range of products Not too much, Not too Wispy, weight loss is something tangible, well balanced, overall healthy!

Not too much, Not too Wispy means balance, balance for the body and mind!

Why just promote one weight loss action, when we can build in the same product different mechanisms of weight loss / volume loss / fat loss?

The Not too much, Not too Wispy range uses innovative active ingredients in their products:

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Not too much, Not too Wispy

Never before as today, in all Mankind’s history, became so clear the importance of maintaining health and perfect functioning of the organism as the main factor of well being.

Wake up, dress, go to school / work, organize our day, meetings, papers, reports, ...

All of us seek, in our day-to-day tasks, to feel in shape, dynamic and with energy. Still, it is more and more common for us to base our diet in processed food, without the natural ingredients so necessary to ensure equilibrium.

®

The use of Camellia sinensis leaves is now described in several scientific publications as a natural stimulant, allowing to directly connect it’s daily consumption to a greater resistance to everyday stress.

The Ginseng root and other adaptogen plants, more than a prompt answer to stress, create conditions for our body to exert a normalizing function, working also as a general tonic, resulting in an important defense against several stressful and demanding situations.

The finest infusion EnergyTea, to be drunk hot or cold, helps our body to maintain a physical and mental balance, improving its overall performance.

Please contact us:

WELLCARE Tel. +351 231 927 590 Fax. +351 231 929 165email@wellcare.pt

Are you interested?

5 minutes of your time are enough to prepare a Wellcare infusion.

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EnergyTea Infusion – CH03040

Wellcare sugest you: EnergyTea

Laboratório de Produtos Farmacêuticos e Nutracêuticos S.A.Edifício Labialfarma Nº1 - Felgueira3450-336 Sobral - MRT - Portugal

Telef. +351 231927590 | Fax: +351 231929165

www.labialfarma.com

Edition:Catarina Madanêlo - Pharma MScCláudia Barroso - Pharma D SpecialistFilipa Queiroz - Pharma MScHelton Santos - PhD, Pharmaceutical TechnologyInês Gonçalves - Pharma MScMelânia Maduro - Pharma MScPedro Cappelle - BA in MarketingPedro Laranjo - BiologistTânia Soares - PhytopharmacistTeresa Telo - Pharma D Specialist, MBA

Rui Cruz - BiologistRevision:

The process of working with medicinal plants begins in the correct species’ identification, adequate collection, correct pre-treatment and storage, and ends with the preparation and therapeutic use, which must be adequate in order for the results to be satisfactory.Any mistake at some link in this chain will jeopardize the outcome of the process.For example: an incorrectly identified species may result in a innocuous product or in a toxic product, because of the intake of a poisonous plant; growing in soil with an inadequate environment, or with pesticides, or even if the collection wasn’t in the appropriate time, can lead to a developed plant with little quantity of the active principle; erroneous storage might destroy the active ingredients or can produce toxicity.

Besides the use of modern analytical techniques (High Performance Thin Layer Chromatography (HPTLC), Gas Chromatography (GC), High Pressure Liquid Chromatography (HPLC), Atomic Absorption (AA) for defining/identify herbal products, the Quality Assurance also requires control of raw materials, storage and process. For this reason, there should be a system of Quality Assurance in Manufacturing to ensure the following items:

The selection of providers and their classification is extremely important, being a major factor of influence to the quality of the final product.

Products based on plants are produced with, mainly, entire plants, fragmented plants, parts of plants, algae, fungi, without any treatment, normally in a dry form, but sometimes in fresh form.

Some exudates, which have not been subjected to special treatment, are also considered vegetable drugs. The vegetal raw-material is correctly defined for its scientific botanical name, according with the binominal system (genus, species, variety and author).

Sanitation and Hygiene

Qualification and Validation

Samples and reference standards

The LABIALFARMA welcomes your comments

Quality Assurance for the Manufacture of Products Based on Plants

Contact us for more information or send us your suggestions. Click Here