Eric Ittah - Consultant Neopharm Labs | Eric Ittah
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Eric Ittah is a successful pharma consultant in Canada. To know more about Eric Ittah, visit www.ericittah.com
Transcript of Eric Ittah - Consultant Neopharm Labs | Eric Ittah
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Neopharm Labs Inc. - To continuously improve performance and apply technologies to serve our client partnership, while investing in competent personnel and talent, and creating a culture of pride in our work.
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1990 – Neopharm begins operations in Blainville 1996 – Acquired by MDS Pharma Services 2006 – Warnex Acquires Neopharm from MDS
◦Company operates 2 sites (Laval, Blainville) 2011 – Restructuring of both labs into Blainville April 2012 – Warnex Analytical Services division sold to private
investors.
◦New name: Neopharm Labs Inc.
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IT (DAS, infrastructure, hardware, LIMS) : $950 K Instrument Upgrade: GC, HPLC, UPLC, Dissolution,
Light Scattering : $875 K New Service : ICP-MS : $225 K Stability Chambers – Expansion : $250 K Microbiology – Biolog & Others : $50 K Total investment: $2.35 M
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Inspected by the US Food and Drug AdministrationMay 2012
Certified by Health Canada’s Health Products and Food Branch Inspectorate (HPFBI) May 2011
Controlled Drugs and substances License April 2012
Audited and qualified by many global pharmaceutical organizations
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Well-established businesses since 1990
Dominant market position in Quebec
Modern facilities FDA and HPFBI compliant Niche in sterility testing Large narcotics vault Walk-in Stability Rooms
Employees 135
Square Footage:•Blainville•Laval
44 00011 000 (ex Warnex)
Certificates of Analysis
1000-1500/mth
HPLC’sUPLC’s
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GC’s 8
AAS 2
ICP-MS 1
Dissolution Apparatus
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Our skilled and competent Chemistry group uses a wide range of methods to test both raw materials and finished products in accordance with compendial procedures including but not limited to:
USP/NF, BP, Ph.Eur, JP, FCC, ACS, AOAC, AOCS, In-house and client supplied methods
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We analyze many types of samples including but not limited to:
◦ Pharmaceutical, veterinary, cosmetics ◦ Finished products: tablets, capsules, liquids, parenterals, otic and
ophthalmic drops, semisolids, creams, gels, shampoos and suppositories
◦ Raw materials: actives, fillers, binders, lubricants, colours and other excipients
◦ Container/packaging components: plastics, glass, foils, bottles, strip packs and cards
◦ In-process products: bulk mixtures of solids or liquids prior to filling into capsules, bottles, vials and syringes, or before compressing into tablets
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Neopharm Labs offers microbiology and sterility testing to help ensure the safety of various products and ingredients including pharmaceuticals, cosmetics, personal care products, vitamins, water, veterinary products, natural health products, etc. All analysis are performed in compliance with cGMP requirements using methods from relevant compendia and pharmacopoeia.
Our experienced microbiology team has expertise in a variety of compendial assays, including: ◦ USP/NF◦ AAMI◦ BP/ Ph.Eur◦ JP◦ AOAC◦ AWWA◦ FDA◦ Client supplied methods
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Antibiotic-microbial assays Antimicrobial effectiveness
testing (AET) Microbial limits Bioburden analysis Desinfectant testing Optical microscopy Water testing
Vitamins Bacterial endotoxin test Methods development and
validation Particle size analysis Microbial identification Crystallinity Sterility testing
The following analyses are performed in compliance with cGMP requirements:
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Team led by Malika Madi – 25 years experience in pharmaceutical and bioanalytical method development and validation.
Collective team experience – 60 years HPLC – RP, NP, Ion exchange Detection – UV, DAD, FLD, ELSD, RID, and Conductivity GC – FID, TCD Method dev., Method transfer, Method validation, Cleaning
validation, USP verification, Forced degradation studies, Assays, Impurities, Residual solvents, Formulation stability, Reverse engineering.
Microbiology Validation Team – led by Isabelle Gladu
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Scientific Solutions◦OOS Resolution◦ Available Team for Communication
Validation Stability Programs Narcotic Vaults Full Service Analytical Lab
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Business Development – Eric Ittah◦ Ext.: 364 [email protected]
Business Development – Marie-Josée Lachapelle◦ Ext.: 330 [email protected]
Customer Service ◦ Ext.: 326, 368 [email protected]
Director, Laboratories– Lina Iacobaccio◦ Ext.: 363 [email protected]
Director, Quality Assurance – Nancy Shore ◦ Ext.: 332 [email protected]
President and CEO– Luc Mainville◦ Ext.: 307 [email protected]
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Neopharm Labs Inc.865 Michele-Bohec Blainville (Quebec)J7C 5J6
www.neopharm.ca
Tel: (450) 435-8864Fax: (450) 435-7595
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