The Quality to Trust On

Transcription

1 The Quality to Trust On

2 Our Quality Policy IS YOUR SAFETY The Quality of our products is an essential requisite for us, prior to release it to the market. So GMPs are applied from the early steps of sourcing any starting material and all-thru the production process to guarantee the Total Quality Assurance of final product and Client Satisfaction. Quality to Trust On 2

3 PROCESSING CONTROLS TO PREVENT ERRORS ND Pharma & Biotech Company Limited, is a Research-Based Global Biopharmaceutical, Biotechnological and Chemical Company that discovers, develops and commercializes innovative medicines in areas of unmet medical needs as well as is operating and conducting businesses in many other fields and sectors, most of them related to human health as food, nutrition, biosciences, neurosciences, industrial solutions, agrochemicals and some other. ND Pharma & Biotech Company brings world-class science and products to the global marketplace in the form of innovative products, materials and services. From controlled production processes to our strict adhesion to GMPs with well defined PROCEDURES and ANALYSIS at every critical step of production, we audit every and all plants working for us both as operated and/or in partnership. Manufacturing processes include a record of all raw data and every critical procedure and parameter thoroughly described for workers and doublechecked in a MBR (Master Batch Record) Library. Our system includes controls on: Quality to Trust On Starting Materials and manufactured parameters. Solvents, residuals, etc. Compliance with different Regulations. Conditions of production. Concentration. Purification. Drying/Liquefaction/Transformation. Packaging/labeling. Cleaning. Equipment Adjustment. Conditioning. 3

4 CHECK and ONCE CHECKED CHECK AGAIN Finished product, no matter use and destination undergoes a final analysis and documentary review. This thorough examination ensures not just compliance with specifications and standards. Leading-edge technology and analytical instrumentation is employed including NMR and HPLC, in strict accordance with suitable, verifiable and validated analytical methods, determination standards and conformation references. Final State involves quality assurance/control review that may include: MBR Documentation review Analytical controls including, but not limited to: An Offer of References Basic Product References Refs. in Fine Chemicals References in Industrial Chemicals NCE s Novel Chemical Entities +80 Brands in Food & Nutrition +21 Refs. of a single-family-brand Content of Active Principles Content of impurities Heavy Metals Pesticides Residual solvents Etc. Physical analysis Microbiological analysis of final product In addition, equipment qualification and periodical maintenance is assured, for a premium quality check in every step that it s made. PreserFoodTM +6 Brands of Agribusiness +23 Brands of Pharmacy and OTC +9 Consumer Brands +15 Lines of Non-controversial Stem Cells Only after observing and taking all this steps in every phase are we confident that our products are ready to enter the market. Quality to Trust On 4

5 Quality you can TRUST ON More than 30 quality controls from starting materials to finished products conforms the ND Pharma & Biotech Company pre-requisite and the unique reliable foundation and grounds to establish a production system that creates value and marks the difference. ND Pharma & Biotech Co. is committed with continuous improvement and TQA (Total Quality Assurance) being actively involved in the process of help and collaborate with different agents and operators, to define regulatory environment, satisfying both authorities and customers. Well established and strong TQA Systems ensures that quality is built-in into the products, from the very beginning to the final processes prior to dispatching it for market circulation, use and/or transformation within any other elaborated one. The quality of a product is controlled during all stages of the manufacturing process by adherence to different standards internationally approved and recognized, but mostly under GMPs and extensive testing and control. Only when our Scientific Officers are fully satisfied, a product qualifies to enter in the market and circulation. Our process doesn t stops at this stage. Our Scientific Office is developing constantly new analytical methods to ensure that products offered are in accordance with the state-of-the art, ad minimum. Quality to Trust On 5

6 About ACCREDITATION and voluntary CERTIFICATIONS ND Pharma & Biotech Company thoroughly audits and inspects every production facility manufacturing, supplying, transforming, packing or working for us. We require up-to-date official permits and licenses, certifications obtained and to pass satisfactorily our upstandard requirements prior to being part of our network and maintaining such status all the time our relationship may last. Ensuring the safety and security of food products is a shared responsibility between the public and private sectors. This is why we are Registered with the competent authorities responsible to establish regulatory standards, inspect facilities, and take action if there are violations, but conscious that industry has the primary responsibility to ensure that food products intended for human and animal consumption in the EU, the US or elsewhere are safe and meet applicable FDA/EC/EU requirements and standards we require form our partners, production plants and industrial suppliers to pass and meet certain processes. Those include ND Pharma & Biotech Co Quality Mark Certification and many other Certification programs that may help industry to improve and fulfill its responsibility by providing an independent evaluation of an establishment s Food/Pharma safety system and, if a problem is discovered, by providing information that can help a firm to fix the problem. So our partners and suppliers are required to have implemented quality systems to ensure they are adhered to international quality and safety standards and if possible to attain other certifications although such are understood that are strictly voluntary. We review in a continuous evaluation system verifying with certifying regulators and agencies that our providers, suppliers and production plants have all the mandatory accreditations and their licenses were not revoked and/or suspended. On average Certifications we ask for GMP, GMP+, IFS, BRC, ISO, HACP, and many other worldwide recognized and accepted. Quality to Trust On 6

7 Glossary of TERMS Accreditation means an attestation related to a certification body (but not by the certification body itself) conveying formal demonstration of its competence to carry out specific certification tasks. Accreditation body means an authoritative body that performs accreditation. Attributes mean the characteristics of a certification body that regulators intends to consider when evaluating whether its certifications are a reliable reflection that food/products from establishments a certification body certifies meets the certification criteria. Audit means the systematic and functionally independent examination of a product, process, and establishment, including records and laboratory testing, as appropriate, to determine an establishment s conformance with certification criteria. Audit activities may include a range of activities, such as on-site examinations of establishments, review of records, review of quality assurance systems, and examination or laboratory testing of product samples. Auditor means a person acting for the certification body who conducts audits and makes a determination of the degree to which certification criteria have been met by an establishment for a particular product type. Certification means the procedure by which a certification body provides assurance that the establishment conforms to certification criteria. Certification should be granted for particular product types produced, manufactured, processed, packed, or held by the establishment. Certification should be, as appropriate, based on a range of audit activities established in our internal control guides. Certification body means a third-party organization that operates a certification program. A certification body could be a Federal, State, local, or foreign government agency, as well as a nongovernment entity that is independent of the businesses it certifies and free from conflicts of interest. Certification criteria mean those criteria used by the certification body during an audit to determine whether an establishment should receive certification. Certification criteria for the purpose of this document should, at a minimum, include applicable FDA requirements. Certification program means a third-party system that verifies, through audits, an establishment s conformance with certification criteria. Certification program assessment means a systematic examination by ND Pharma & Biotech - Intabiotech to assess a certification body s conformance with the attributes settled within our manuals and guides. Establishment means a site-specific domestic or foreign facility that produces, manufactures, processes, packs, or holds food for use, consumption, or further processing in the EU/US (applicable to elsewhere). Inspection means the examination of a product, process, or establishment, including records and laboratory testing, performed by ND Pharma & Biotech aside of governmental entities or any other acting under authority, such as a State regulatory authority. Self-assessment means a certification body s systematic assessment to determine whether its activities and related results meet planned objectives (e.g., the attributes in this document). Third party means an organization other than the establishment or ND Pharma & Biotech Intabiotech. A third party could include a Federal, State, local, or foreign government authority that is not conducting inspections, as well as a private entity. Quality to Trust On 7

8 Directory/Contacts FEEL FREE TO CONTACT US General General Information Point General Services (Central) Board of Directors CEO (Chief Executive Officer) and VP of the Board CSO (Chief Scientific Officer) CCO (Chief Circulation Officer) CLO (Chief Legal Officer) CFO (Chief Financial Officer) CCO (Chief Compliance Officer) GS (General Secretary) GCO (General Corporate Officer) Subsidiaries GLAICE General Information Point The Glaice Water Co. ALKIOW ND Innovation Administration / Services Administration (Central) admon@ndpharmabiotech.com Corporate Services (Central) corporate@ndpharmabiotech.com Legal Office (Central) legal.ndpharma@europe.com Comptrol Office (Central) sr.ndpharma@europe.com Marketing/Publications Service marketing@ndpharmabiotech.com Business Development Office bdu.ndpharma@europe.com Business Intelligence Unit biu.ndpharma@eruope.com Research Centre ndpharmabiotech@tech-center.com Regulation Office regulation.ndpharma@europe.com Regulatory Office (Intabiotech) regulatory@intabiotech.com Commercial/ Services International Director international@ndpharmabiotech.com Commercial Branch intabiotech@intabiotech.com Commercial Coordination intabiotech@europe.com Legal Office Commercial legal@intabiotech.com Commercial General (French Speaking Countries) commercial@ndpharmabiotech.com Commercial (Eastern/Central Europe iulia.dumitrascu@ndpharmabiotech.com Industrial Division industrial@ndpharmabiotech.com Chemical Division ndpharmabiotech@chemist.com Commercial (Labs Division) s.pico@ndpharmabiotech.com Commercial (Iberia) jr.castells@ndpharmabiotech.com Commercial (Latin American Countries) General latam@ndpharmabiotech.com Commercial (LATAM Countries) Delegate mv.ndpharma@samerica.com ND Pharma & Biotech is a Company Limited by Shares Registered in England and Wales under Companies Act Capital Shares of 1 /Share. Registered Office in Surrey, England, UK Corporate Offices in London, England, UK Quality to Trust On 8

9 World Presence Production Centers, Partners and Distributors in 26 Countries With Partners and Distributors Worldwide we are proudly operating in 5 Continents. We can serve each client with a global perspective throug on local basis, as preferred ND Pharma & Biotech Co. Registered Office, Surrey, England Corporate Offices, London, England Research + Innova=on Centre, Dorset, UK Logis=cs, Newcastle, UK ND Pharma Intabiotech SLU Registered Office, Valencia, Spain Corporate Offices, Paterna, Spain Pharma Division, Madrid, Spain Commercial Division, La Coruña, Spain Industrial Division, Narón, Spain Logis=cs/Control, Tarragona, Spain Quality to Trust On Contact Us: General Regional Areas Europe, Middle East & Africa ndpharmabiotech@europe.com North America ndpharmabiotech@usa.com Latin American Countries ndpharmabiotech@samerica.com Asia-Pacific ndpharmabiotech@asia.com 9

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