Select Botanical is a spanish company based in Barcelona with a production plant in Buñuel (Navarra); focused in the research, development, manufacture and commercialization of extracts and active ingredients of herbal origin.
SB provides with technical and scientific product documentation. It also provides customers with technical-regulatory advising.
DRUG MASTER FILES
SB offers Drug Master Files in CTD format (Common Technical Document), to our customers in Pharmaceutical Industries.
MANUFACTURING PROCES VALIDATIONS
SB performs manufacturing process validations, to guarantee an effective and reproducible processing in obtaining a product that complies with the required quality specifications.
SB performs analytical methods validations to demonstrate that it is suitable for its intended purpose.
SB performs stability studies following ICH recommendations (International Conference on Harmonization).
Company founded in 2001 by a group of professionals specialized in the field of herbal extraction with high knowledge and experience in this activity.
Our location in Navarra provides us with an agricultural proximity model as this area is a premier agricultural region in Spain. Therefore, the products obtained in this region offer better traceability and guarantee on quality of the raw material.
The purpose of the Quality Policy of Select Botanical SL is to satisfy the needs and expectations of our customers. Quality Policy is leaded by General Management and requires a permanently effort of each employee.
Our goal is to offer products and services which comply with the customer requirements, respect the environment and according to the current legislation, as well as to ensure a continuous improvement of our products and services.
QUALITY MANAGEMENT SYSTEM
Select Botanical, SL has implemented an effective harmonized Quality System based on International Standards Organization (ISO) quality concepts and Good Manufacturing Practices (GMP) standards.
QMS is implemented through entire product lifecycle, since development, manufacture until product delivery to customer.
Our QMS implemented facilitate innovation and continuous improvement of business, processes, product quality and Quality System.
R & D
Our R&D team is focused in developing new concepts taking into account the needs of the market and our customers, according to the current regulatory requirements.
Our goal is to design and develop new applications, products, process and analytical methods. Key points:
- High technological innovation capacity
- Market knowledge
- Customer relationships
- Development expertise
- Partnership with universities and research centers
Our production plant in Buñuel (Navarra) with an extraction capacity of over 500 tons of raw material, is designed with the latest technology and strict safety standards in order to meet the quality criteria and good manufacturing practices (GMP) standards. The last manufacturing steps are performed in Clean Rooms Class D / ISO 8.
Select Botanical SL has been certified by the AEMPS as manufacturer of active substance in compliance with GMP regulations.
Select botanical, SL, as manufacturer of medicinal plant extracts and active principle derivatives recognize that our activities have an impact on the environment.
Aware of the importance of respect and care for the environment, Select Botanical,SL acquires the commitment to establish an Environmental Management System to minimize the environmental impact of our activity. For this, Select botanical, SL, as manufacturer of medicinal plant :
- Implement an Environmental Management System according to the international UNE-EN-ISO 14001 standard.
- Implement corrective and preventive measures to reduce the consumption of energetic resources, especially water and electrical energy, as well as, decrease the waste generation and minimize the environmental impact of the atmospheric emissions.
- Promote continuous improvement process to guarantee the control and progressive reduction of the environmental impacts.
- Perform audits to verify the system effectiveness.
- Perform environmental training to the personnel.
We ensure compliance with standards and specifications, in order to guarantee the quality of our products, and ensure the quality of manufactured batches in the shortest possible time-scales.
- Raw material selection: We search and select Raw material that fits our necessities through specific analysis using different analytical techniques.
- Processes Control: Control of each critical step during the process to guarantee the product quality.
- Laboratory equipment for monitoring and identifying analytical markers / active compounds (HPLC, UV/Vis spectrophotometer, Gas Chromatography)
- Analytical methods described in Pharmacopoeia (European, USP, French, DAB, etc.) as well as internal company validated methods.