May, 2007 -
Sterility Assurance Compliance and
Assessing Biocompatibility Guidebooks - updated versions available.
We have recently
updated both of the above guides.
Click
here to view them online or complete our
Compliance Guides - Request Hard
Copy form.
Northview Biosciences acquired by SGS
February, 2006 - Northview Biosciences and its two operations Northview Laboratories in
Northbrook, Illinois has been acquired by SGS, the world's leading inspection,
verification, testing and certification company. The acquisition did not
include Northview Pacific Labs and its animal science facility in Hercules,
California. Northview Pacific Labs will be reorganized at Pacific BioLabs (www.pacificbiolabs.com),
a specialty service provider.
Northview is now part of the Life Science Services Group of SGS. Together
with the SGS laboratories in New Jersey and Ontario, we are the leading
network of laboratories providing high quality GMP/GLP testing services in
analytical chemistry and microbiology to pharmaceutical, biopharm, medical
device and other FDA regulated companies in the U.S. and Canada.
In addition to our quality control focused testing services, SGS Life
Science Services is a leading global provider of drug development services for Phase
I to IV clinical trials, biostatistical management services, regulatory
affairs services and bioanalytical laboratory services.
For more information about SGS Life Science Services, click:
www.sgs.com/lifescience
Northview is a great " fit" with SGS Life Science Services. We are all committed to
working to continuously improve our testing services, meeting and exceeding
our clients' expectations and growing our business. All of your Northview
contacts will stay the same. We thank all of our clients for using
Northview's testing services look forward working with you in the future.
Ongoing Investment in Analytical Capabilities - Polarimetry
& Refractometry
We continue to improve and expand our analytical capabilities by adding new
equipment at both our Illinois and South Carolina laboratories.
Polarimeters: At NVL in Northbrook, we have recently purchased a
Rudolph Research Autopol V Polarimeter. We also have added polarimetry
capability to our Spartanburg, SC lab. The polarimetry information below is
from Rudolph's website:
Polarimetry is a sensitive, nondestructive
technique for measuring the optical activity exhibited by inorganic and
organic compounds. A compound is considered to be optically active if
linearly polarized light is rotated when passing through it. The amount
of optical rotation is determined by the molecular structure and
concentration of chiral molecules in the substance. Each optically
active substance has its own specific rotation as defined in Biots law:
The polarimetric method is a simple and accurate means for determination and
investigation of structure in macro, semi-micro and micro analysis of
expensive and non-duplicable samples. Polarimetry is employed in quality
control, process control and research in the pharmaceutical, chemical,
essential oil, flavor and food industries.The USP, EP and JP include
polarimetric specifications for numerous substances.
Refractometers: At NVL, we have purchased a new Rudolph Research J357
Refractometer. This model has a wide measurement range of 1.29 to 1.70 R.I.
It can be used to measure every material in the USP, EP, BP and JP.
Refractive index is the ratio of the speed of light in vacuum (a constant)
to the speed of light in a particular medium. This number signifies how well
a material can refract light. Usually specified as n, the index of
refraction of a material depends on its composition and density. Water
has an index of refraction of 1.333; n of air is nearly 1.0;
and n of a vacuum is exactly 1.0.
Photostability Testing at Northview
We have recently added an Environmental Specialties photostability chamber
to our Northbrook laboratory. This enables us to offer testing in accordance
with ICH guideline Q1G Photostability Testing of New Drug Substances and
Products. According to the ICH guideline, light testing should be an integral
part of stress testing. The photostability characteristics of drug products
should be evaluated to demonstrate that light exposure does not result in
unacceptable change. Test samples are exposed to light providing an overall
illumination of not less than 1.2 million lux hours and an integrated near
ultraviolet energy of not less than 200 watt hours/square meter. At the end of
the exposure period, the test samples should be examined for any changed in
physical properties and for assay and degradants by a method validated for
products likely to arise from photochemical degradation processes.
The photostability chamber holds one light bank capable of supporting both
cool white and ultraviolet studies. Intensities are individually controlled at
each light bank to allow for simultaneous testing at different light levels. A
microprocessor based controller and photodiode sensor provide a fully
automated closed loop control system. The temperature range of the chamber is
20 – 40C.
Northview uses many stability chambers for pharmaceutical stability studies
and accelerated aging studies of medical devices. We also rent space in our
environmental chambers for projects in which clients do their own product
testing and evaluation. In addition to the photostability chamber, we maintain
stability chambers at 25C @ 60% R.H., 40C @ 75% R.H., 5C, 30C @ 65% R.H, 40C @
15% R.H, 55C @ <20% R.H. and 55C @ 75% R.H. Dedicated alternate temperature
and humidity conditions may also be available, depending on our other
commitments.
Click to read the ICH guideline about photostability testing.
Northview Offers USP & EP Nitrogen Gas Testing
Northview’s Analytical Laboratory now offers nitrogen gas testing in
accordance with USP and EP procedures:
-
USP 27 requirements: Identification, Odor, Carbon Monoxide, Limit of Oxygen
and Assay
-
EP requirements: ID A, ID B, ID C, Carbon Dioxide, Carbon Monoxide, Water
Vapor and Assay
With notice, the testing can completed within one week. To facilitate nitrogen
gas sample collection, Northview also rents stainless steel lecture bottles.
For more information or pricing and please call our business development
department at 847-564-8181.
Northview Offers Trace Metals Using ICP Spectroscopy
In a continuing effort to improve our client service and expand our testing
capabilities, Northview has purchased Thermo Electron’s newly updated IRIS
Intrepid II XDL ICAP Spectrometer with enhanced networking and instrument
control electronics. This ICP is a highly sensitive radial view plasma
emission spectrophotometer that perfectly complements our Varian Atomic
Absorption (AA) Spectrometer for elemental analysis.
ICP-AEC, usually simply referred to as ICP, is a multi-elemental technique
that uses an inductively coupled plasma source to dissociate the sample into
its constituent atoms or ions, exciting them to a point where they emit light
of a characteristic wavelength. A detector measures the intensity of the
emitted light and calculates the concentration of that particular element in
the sample.
When undergoing ICP analysis, the sample experiences temperatures as high as
10,000C, where even the most refractory elements are atomized with high
efficiency. The ICP instrument’s excellent signal-to-noise ratios results in
better resolution and lower detection limits to enable the determination of
part-per-billion (ppb) levels of metals in pharmaceutical products.
Thermo’s intuitive 32-bit TEVA™ software application operates all aspects of
the instrument and facilitates regulatory data compliance with integrated 21
CFR Part 11 controls. The installation and operational qualification of the
instrument was successfully performed by Thermo Electron following the vendor
supplied IQ/OQ service package. Subsequently, Northview’s staff is finalizing
the validation of the system with a thorough gap analysis of the system with
respect to Part 11 regulations.
Note: Some of the information above is from Thermo-Electrons promotional
material.
Click to request a quotation for elemental
analysis by ICP or AA testing.
Disinfection Validation
at SGS Northview
A variety of disinfectants are widely used for sanitization in
pharmaceutical cleanrooms and aseptic processing areas. SGS Northview
offers customized studies to validate the effectiveness of a manufacturer’s
disinfection regimen. These studies are performed by applying the selected
disinfectants to coupons of cleanroom construction and equipment materials.
The materials are inoculated with a variety of bacteria and mold, often
including environmental isolates. Disinfectant is applied to the coupons and
then the coupons are tested for the population of surviving microorganisms.
Acceptance criteria are based on log or percentage reduction from the
pre-disinfectant exposure microorganism population on the test material
coupon.
May 2005 -
FDA
and ISO audit Northview’s facilities
Northview Biosciences is a contract testing laboratory. Since we perform
pharmaceutical testing services, each of our 3 labs is registered with the
FDA as a Drug Establishment. Each year, FDA Form 2656 is completed by the
Quality Assurance group and sent to the FDA to maintain our registration
status. The registration requires that Northview follow the cGMP guidelines
as detailed in 21 CFR 210 & 211.
Since Northview is listed on many New Drug Applications (NDAs), the FDA can
perform a pre-approval inspection of our facility at any time. Northview is
also inspected approximately every two years by the FDA for a general cGMP
inspection. In these general inspections, the quality systems and a random
selection of raw data are reviewed by FDA investigators. Northview
Laboratories two most recent FDA inspections were in March 2003 and April
2005. We use information and feedback provided by the investigator during
the inspection to assess our quality systems and process and implement
improvements. Northview successfully completed both the 2003 and 2005
inspections without any 483 observations. We will continue to strive to
maintain our excellent track record with the agency.
Each Northview facility is also audited annually by our ISO auditor.
Northview has been certified to ISO 9001 since 1998. Northview recently
transitioned to the current version of the standard, ISO 9001:2000. Our
Northbrook, IL lab successfully completed a surveillance audit in March 2005
with no observations. If you would like to receive a copy of our ISO
certificate, please contact the Quality Assurance group.
May 2005 -
Client Q.A. Staff Audit Northview’s Labs
As a contract laboratory, Northview is considered to be an extension of
our client’s quality control testing lab and must be ready for a client or
regulatory inspection at any time. For example, in 2004, Northview
Laboratories, our Northbrook, IL facility, hosted 71 client audits. During
these audits, client representatives received a Power-Point overview of our
facility, staff, equipment and capabilities and tour of our facility Client
audits also included a review of Northview’s quality systems and raw data
for their testing projects.
For those clients that can’t make it on-site, the Quality Assurance group at
Northview Laboratories has put together a quality packet that contains all
the information required to assist in approving our lab as a testing
subcontractor. If you would like to schedule a one day audit of our
facility, please contact the Quality Assurance group at Northview and we
would be happy to assist you scheduling an audit date. There is no fee for a
one day on-site audit. For those clients requiring more than one day, an
hourly fee for the second day on-site can be arranged.
Northview Laboratories is dedicated to keeping current on all regulations
and client needs. Through an active internal audit program, we continually
are improving our systems to provide our clients with the best service
possible at the highest quality. Our adherence to cGMP and ISO regulations,
along with listening to our client suggestions and needs, has helped
Northview Biosciences become a service leader in our industry.
May 2005 -
Do You Need a Quality or Confidentiality Agreement?
In an FDA Guidance for Industry titled, “Quality Systems Approach to
Pharmaceutical Current Good Manufacturing Practice Regulations”, the agency
speaks to the topic of Controlled Outsourced Operations. In this section of
the guidance, the FDA states, “Quality systems call for contracts (Quality
Agreements) that clearly describe the materials or service, quality
specifications responsibilities, and communication mechanisms.” While a
detailed “Request for Testing could meet this requirement, Northview has
drafted a basic Quality Agreement that is available to our clients to
review, modify as needed and sign. It details the service, specifications,
and responsibilities that are required from our clients and Northview
Biosciences.
Many clients and prospective clients require an executed Confidentiality
Agreement before disclosing confidential product and/or procedural
information to Northview staff. We have a standard agreement available for
client use.
Please contact a member of the Quality Assurance group if you are interested
in executing either our standard Quality Agreement or Confidentiality
Agreement. Alternatively, clients may submit their own Quality or
Confidentiality Agreements and submit them for Northview’s review, possible
revision and signature.
May 2005 -
Northview Improves Document Storage with Barcode Scanning
While Northview has a central lab management computer system for
processing clients’ requests for testing including generating laboratory
reports, and many computer based analytical instruments, we still generate
many paper lab documents related both to internal QA/QC requirements and
documentation of clients’ testing.
On January 1st 2005, Northview Laboratories began scanning all client sample
submission documents, Northview “labsheet” work orders, completed laboratory
raw data worksheets and final reports of analysis. The scans are neatly
organized within a document storage system called Intact. Scanned document
collection and organization is keyed off of a barcode that is added to all
labsheets and reports. The barcode is recognized by the Intact software and
facilitates communication between the Intact database and our Lab Management
System database. After the scans are collected by the Intact software, data
attributes from the Lab Management System are associated with each document.
This allows for quick and easy searching for documents using information
such as client name, sample identification, PO number and more.
Our barcode scanning system has greatly improved our efficiency and customer
service by giving our staff the ability to quickly access information from
their desk top computer instead of going to the file room and searching
through file cabinets for paper documents.
