contract manufacturing pharmadus version english
DESCRIPTION
Our modern facilities were technically planned to guarantee compliance with European Union´s Good Manufacturing Practise standards (GMPs) Pharmadus as an manufacturing laboratory for third party companies,for medical herbal teas thar are recognises as: -Plant-bases medicines -Traditional plant-bases medicines -Food supplements -Herabl teas for human consumption www.pharmadus.comTRANSCRIPT
CONTRACT MANUFACTURING
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PHARMADUS is a pharmaceutical laboratory dedicated to the production of natural herbal tea products. PHARMADUS is the result of more than 50 years experience and commitment to the world of phytotherapy.
Our modern facilities (that opened in 2006) were technically planned to guaran-tee compliance with the European Union’s Good Manufacturing Practise standards (GMPs), throughout all phases of the packing process.
has been granted the following authorisations:
This allows us to introduce PHARMADUS as a manufacturing laboratory for third-party companies, for medicinal herbal teas presented in individual tea bags that are recognised as:
• Plant-based medicines.
• Traditional plant-based medicines.
• Food supplements.
• Herbal teas for human consumption.
- For the production of medicinal plant based herbal teas. Laboratory number: 4203-E
- For the production of herbal teas for human consumption: R.G.S.A. 25.01949/LE
- For the manufacture of Food Supplements: 26.12199/LE
- For the manufacture of organic products
- For the manufacture of Kosher products
AUTHORISATION
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Comprehensive management for the manufacture of natural herbal tea products presented in individual tea bags, which adheres to the Good Manufacturing Practise standards (GMPs).
DEVELOPMENT• New product development.
a. Document search.
b. Galenic development.
c. Preparation of technical data, information leaflets and specialist reports.
d. Stability assessment.
e. Pilot batch production.
f. Process validation.
g. Analytical development and validation of methods.
h. Technical support for the preparation of registration records.
• At PHARMADUS we have a large team of specialised professionals as well as external collaborators, companies within the sector and investigation centres.
services
objective
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PRODUCTION• Selection and purchase of raw and packing materials.
• Packing of herbal tea products presented in individual tea bags.
• Preparation of packing materials.
• Inspection of raw materials, process and finished product controls.
• Storage of raw materials, packing material and finished product ready for
marketing.
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PRODUCTS3.1. Heat-sealed filter tea bags (without staples). Size: Boxes of 10/25 tea bags.
3.2. Filter tea bags (double chamber tea bag without staples). Size: Boxes of 20/25
tea bags, with or without outer heat-sealed sachet.
3.3. Nylon pyramid tea bag. Various sizes.
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WAREHOUSES
a. Reception area.
b. Packing material warehouse.
c. Plant preservation chamber.
d. Rejected product area.
e. Finished product warehouse.
f. Dispatch area.
facilitiesOur facilities of more than 10,000 m2 are divided as follows:
planta baja
primera planta
CONTRACT MANUFACTURING
PHARMADUS laboratories, Procesos Farmacéuticos Industriales, S.L., is located 7 kilometres from Ponferrada (León), Spain, in Polígono Industrial de Camponaraya, and can be accessed directly from the A-6 dual-carriageway.
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SAMPLING ROOM
a. Sample library.
b. Stability testing room.
c. Physicochemical laboratory.
d. Microbiological laboratory.
QUALITY CONTROL LABORATORY
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a. Primary packaging room.
b. Secondary packaging room.
PRODUCTION LABORATORY
TECHNICAL AREA
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We have selected and approved the best suppliers and regularly use quality audits to test their products.
The PHARMADUS facilities and processes have been designed to ensure that each product is strictly controlled, therefore avoiding any kind of contamination.
• Pharmaceutical clean rooms class 100,000 (D or ISO 8),
for sampling and primary packaging.
• Pressurised Safety Access Systems (SAS).
• Purified water (Ph.Eur ) to clean equipment.
• Controlled temperature and humidity.
• Air treatment system.
• Dust collection system.
QUALITY AND SAFETY
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Our control laboratory contains the most advanced analytical techniques.
• High performance liquid chromatography and UV-VIS
spectrophotometry, to identify active ingredients.
• Gas chromatography to identify pesticides.
• Atomic absorption spectrophotometry to identify heavy metals.
• Detection of pathogenic microorganisms using molecular biology
(quantitative PCR method).
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HUMAN RESOURCES
At PHARMADUS we have a highly qualified team of professionals that is trainedon a regular basis, with an extensive knowledge of working with GMPs.We can offer excellent service because we have the best professionals.
CONTRACT MANUFACTURING
PROCESOS FARMACÉUTICOS INDUSTRIALES, S.L.Pol. Ind. de Camponaraya. Sector 2. Parcela 324410 CAMPONARAYA · LEÓN · (SPAIN)Tfno.: +34 987 46 40 72. Fax: +34 987 46 40 [email protected]
www.pharmadus.com