Merck Moving Beyond Passwords: FIDO Paris Seminar.pptx
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 Administration
May 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
44 000
11 000 (ex Warnex)
Certificates of
Analysis
1000-1500/mth
HPLC’s
UPLC’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 eittah@neopharm.ca
Business Development – Marie-Josée Lachapelle
◦ Ext.: 330 mjlachapelle@neopharm.ca
Customer Service
◦ Ext.: 326, 368 sc@neopharm.ca
Director, Laboratories– Lina Iacobaccio
◦ Ext.: 363 liacobaccio@neopharm.ca
Director, Quality Assurance – Nancy Shore
◦ Ext.: 332 nshore@neopharm.ca
President and CEO– Luc Mainville
◦ Ext.: 307 lmainville@neopharm.ca
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