Test Article Characterization – A GLP Requirement

5 Key Points of Test Article Characterization (TAC)

Test Article Characterization
Good Laboratory Practices (GLP)

Identity

The name under which the article will be tested Include CAS number, lot or batch, if applicable

Composition

The list of ingredients making up the test article

Strength

The stated concentration of an active ingredient in a test article mixture

Purity

The fraction that is the active ingredient (relative to impurities), usually expressed as a percent

Stability

The duration for which the test article will remain undegraded under the storage conditions provided

Why is Test Article Characterization (TAC) necessary?

When a study is conducted according to the Good Laboratory Practices regulations (GLPs), providing characterization of the material to be tested (the test article) to the Testing Facility (MB Research) is required.

Do you have characterization of the test article (e.g., Certificate of Analysis, or similar)?

Yes – Please provide this to MB Research prior to study initiation (signing the protocol, beginning the experiment).

No –Select ‘no test article characterization’ on the Sponsor Request section of the MB Research protocol. No further action is necessary. Refer to the GLP Compliance section below.

If yes, was test article characterization/analysis performed according to Good Laboratory Practices (GLPs), Good Manufacturing Procedures (GMPs), or neither*?

 Please select GLP, GMP, or non-GLP/non-GMP on the Sponsor Request section of the protocol.

Does your TAC include all five of the following GLP-required parameters?

Yes – The study will be in complete GLP compliance. No further action is necessary.

No – Refer to the GLP Compliance section below.

Good Laboratory Practices (GLP) Compliance 


A GLP compliance exception statement appears in the study report when TAC –

(1) is not provided

(2) is not provided prior to study initiation (signing the protocol)

(3) does not include all five of the parameters, and/or

(4) is not performed according to GLPs

MB Research Labs is a contract GLP toxicology lab with over 45yrs of experience in chemical, consumer product and cosmetic safety assessment.

www.mbresearch.com

MB specializes in in vitro toxicology testing and development of alternatives to animal models for toxicological assessments.

 

 

Pharmaceutical Toxicology Testing – MB Research Labs

Pharmaceutical Toxicology Testing
Pharmaceutical Toxicology Testing

Your Trusted Toxicology Testing Partner

We have the Experience.

Since 1972, MB Research Labs is a GLP contract research organization (CRO) that has been performing toxicology (acute, subchronic / chronic) and pharmacology studies for leaders in the pharmaceutical, biotechnology, medical device and agrochemical industries and government agencies.
With a wide range of testing protocols available, MB Research Labs offers comprehensive capabilities to to address your unique needs and goals with speed and accuracy.
Our expertise in many areas of in vivo and in vitro testing, research, and safety evaluations is the foundation upon how MB Research serves the pharmaceutical toxicology testing needs of both government and industry.

Complete support services including consultation, protocol development, quality assurance, analytical chemistry and archive facilities are integral components of studies performed at MB.
Our technical and support procedures are in full compliance with OECD, FDA, and EPA.

Related Toxicology Testing

EPA-OCSPP Testing

  • MB offers GLP Toxicology Testing for pesticides and chemicals.
  • Extensive list of Protocols Available
  • Discount Pricing

Photo-Toxicology

  • In Vitro 3T3 Neutral Red Uptake Phototoxicity Test
  • Monolayer & 3D Tissue Models
  • OECD 432 protocol

In Vitro Toxicology

  • Your Source for In Vitro & Alternatives to Animal Testing.
  • Cost Saving Screening Testing
  • Cosmetics & Personal Care Testing

MB Research Labs is a leader in the use and development of
in vitro and alternative toxicology test methods. We specialize in protocols for Eye and Skin Irritation, Corrosivity, Skin Sensitization, Genotoxicity, and Phototoxicity.

For more info about MB Research.

In Vitro Cosmetic Safety Testing – NYSCC 2017

MB Research Labs Goes to NYSCC 2017. Offers Quality In Vitro Testing for Cosmetics.

MB Research Labs Goes to NYSCC 2017
MB Research Goes to NYSCC 2017

Visit MB Research @ Booth#1440 for the latest on In Vitro Cosmetic Safety Testing
New York Society of Cosmetic Chemists Supplier’s Day
May 2-3, 2017, Jacob Javits Convention Center, New York, NY

MB Research Labs is a leader in the use and development of
in vitro and alternative toxicology test methods. We specialize in protocols for Eye and Skin Irritation, Corrosivity, Skin Sensitization, Genotoxicity, and Phototoxicity.

For more info about MB Research.

56th Society of Toxicology Annual Meeting 2017 – Baltimore, MD – MB Research Labs

MB Research Goes to Baltimore 2017 SOT
56th Annual Meeting – Society of Toxicology

SOT 2017 MB Research Informational Page

MB Research Goes to Baltimore – Society of Toxicology 2017

 

Join Us at the 56th Annual Meeting of the Society of Toxicology and ToxExpo , Baltimore, Maryland, March 12-16, 2017

Stop by Booth#: 2469 and meet some of our Study Directors and Client Services.

Scientific Posters:

The h-CLAT for Assessment of Dermal Sensitization Potency of the OECD Proficiency Chemicals and of Commercially Available Mixtures

Wed 1:15pm-4:30pm. Session: Alternatives to Mammalian Models I, Abstract 2748, Poster Board P116

Further Evaluation of Chemicals and Mixtures for Skin Sensitization Potential and Potency Using a Reconstructed Human Epithelium (RhE) Tissue Model and the IVSA.

Wed 1:15pm to 4:30pm. Session: Autoimmunity/Hypersensitivity, Abstract 2957, Poster Board P508

Historical Performance of Weak Sensitizers in Different Animal Models.

Tues 9:30am-12:45am. Session: Non-Phamaceutical Safety Assessment, Abstract 1873, Poster Board P449

Resolving Corrosive/Severe Irritant Ocular Classifications using an Alternative Dual Ex Vivo Assay System.

Wed 1:15pm-4:30pm. Session: Alternatives to Mammalian Models I, Abstract 2761, Poster Board P129

 

Toxicology Testing Services – Your Expert Toxicologist

Your Expert Source for Acute Toxicology Testing


Toxicology Testing Services
Toxicology Testing Services

Over 45 Years of Toxicology Testing – Chemicals, Pharmaceuticals, Cosmetics, Household Products, Personal Care Products

MB Research Laboratories, a GLP contract research Toxicology laboratory, has been conducting acute, subchronic / chronic toxicological and pharmacological studies since 1972. MB Research provides industry-leading general toxicology services for the pharmaceutical, biotechnology, medical device and agrochemical industries and government agencies. Routine and non-traditional toxicology studies are performed, custom testing services to meet specific testing needs is available.

Study Directors and technicians strive to consistently deliver exemplary results to support both Good Laboratory Practices(GLP) and non-GLP Toxicology studies. With a wide range of in vivo and in vitro test protocols available, MB Research Labs offers comprehensive Toxicology Testing capabilities to address your unique needs and goals. With expertise in many areas of in vivo and in vitro testing, research, and safety evaluations, MB Research serves the testing needs of both government and industry.

Complete support services including consultation, protocol development, quality assurance, analytical chemistry and archive facilities are integral components of studies performed at MB. Our technical and support procedures are in full compliance with OECD, FDA, and EPA.

MB Research Labs

Video Link: Replacing Animal Testing with Cultured Human Cells

Great video on advancement of in vitro alternative testing methods in Europe.

EuroNews Knowledge – Replacing Animal Testing with Cultured Human Cells

MB Research Labs is a leader in the US for development and validation of in vitro alternative test methods that reduce/replace the need for using live animals in product safety testing of consumer products, chemicals, pharmaceuticals and cosmetics.

More information about MB Research Labs and our Toxicology Testing Services….

Phototoxicity Testing Services – 3T3 NRU PT

Phototoxicity / Phototoxicology Testing

3T3 NRU PT phototoxicity
3T3 NRU PT phototoxicity

MB Research Labs is a leading in vitro toxicology laboratory that offers toxicological testing services to the cosmetic, chemical and pharmaceutical industries.

One of the more important assays offered in the 3T3 Neutral Red Uptake Phototoxicity (3T3 NRU PT) Assay. The 3T3NRUPT is used to screen test materials for the potential of causing photoirritation after exposure to the material and sunlight.

The 3T3 NRU PT was developed and validated in a joint EU/COLIPA project from 1992-1997. In 1996, the 3T3 NRU PT was recommended by OECD as an in vitro approach for the assessment of chemicals phototoxicity potential. In April 2004, the 3T3 NRU PT protocol was finalized and adopted as the OECD 432 protocol, In Vitro 3T3 NRU phototoxicity test.

The 3T3 NRU PT can be utilized to identify the phototoxic effect of a test substance induced by the combination of test substance and light and is based on the comparison of the cytotoxic effect of a test substance when tested after the exposure and in the absence of exposure to a non-cytotoxic dose of UVA/vis light. Cytotoxicity is expressed as a concentration-dependent reduction of the uptake of the vital dye – Neutral Red.

Substances that are phototoxic in vivo after systemic application and distribution to the skin, as well as compounds that could act as phototoxicants after topical application to the skin can be identified by the test. The reliability and relevance of the 3T3 NRU PT have been evaluated and has been shown to be predictive when compared with acute phototoxicity effects in vivo in animals and humans.

For more information about the 3T3 NRU PT and MB Research Labs….

Cosmetic Safety Testing

Cosmetic Products and Ingredient Safety Testing

Cosmetics are required to be safe when consumers use them according to directions in the labeling, or in the customary or expected way.
To ensure the safety of a cosmetic product, manufacturers may conduct cosmetic safety testing.

Cosmetic products and ingredients (except for color additives) do not require FDA approval before being released on the market.
The FDA does not have a list of mandatory tests required for any particular cosmetic product or ingredient. Action can be taken against the manufacturer of a cosmetic on the market if we have reliable
information to show that a cosmetic does not meet the legal requirement for safety.

Color additives are treated differently. Unlike other cosmetic ingredients, color additives (other than coal-tar hair dyes and related materials)
must be approved by the FDA for the specific intended use before they are permitted in cosmetic products.

Your Cosmetic Safety Testing Partner

MB Research has been conducting product safety assessments for the cosmetics, personal care, chemical and pharmaceutical industries for over 40 years and is often sought out by Cosmetics Industry Leaders to ensure the safety their ingredients and aid in the rapid development of products.
Slider-3
We are a leader in the use and development of In Vitro and Alternative Toxicology Tests and continue to introduce new testing methods regularly.

Cosmetic, Beauty and Healthcare product industries are subject to global regulatory requirements such as the EU Cosmetics Directive (76/768/EEC) in response to growing concern over the safety of cosmetic products and their ingredients.

For more information about MB Research and our In Vitro Toxicology Testing Capabilities…

In Vitro Sensitization Testing for Fragrances

http://www.skininc.com/skinscience/ingredients/The-Frustration-Behind-Fragrance-389249991.html

MB Research actively has been utilizing in vitro and alternative toxicology test methods for determining dermal sensitization for many years.

Regulatory accepted assays are available.

We have an extensive background in in vivo and in vitro test method development.

For More: http://www.mbresearch.com/in-vitro-sensitization.htm

More on in vitro toxicology testing.

We want to be your Trusted Toxicology Partner.

Corrosivity Testing: Kit or Out-Sourced Testing?

in vitro Corrosivity testing - in vitro toxicology
in vitro Corrosivity testing – in vitro toxicology

Hazardous shipping labels can be complex.  There are kits that can be purchased that can satisfy regulatory requirements, but getting a kit alone does not provide they well-being you get when the test is performed by an experienced laboratory with a excellent quality assurance follow up and an acutal report.

See Corrositex.com

Having a test performed by a quality testing lab adds value to your product and shows to your customers that you are dedicated to their safety.

Consider testing with MB Research Labs…..we are your Trusted Testing Partner.

More info on in vitro toxicology testing.