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Laboratory Expert Exchange |
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| SCIENTIFIC IMAGE CREDIT: Cynthia Goldsmith, US Centers for Disease Control and Prevention (CDC). This negative-stained transmission electron micrograph (TEM) depicts the ultrastructural details of an influenza virus particle, or “virion.” |
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| Oxidative Stress Assessment at Kronos Science Laboratory
Submitter: Kronos Science Laboratory
Oxidative Stress Assessment at Kronos Science Laboratory
by
Christopher B. Heward, Ph.D. and Yali Su, Ph.D.
In recent years, research evidence has been accumulating that damage to cell components (proteins, cell membrane lipids, and the DNA of both chromosomes and mitochondria) by oxygen free radicals (also known as "reactive oxygen species" or ROS) is an important mechanism of aging. Oxidative damage seems also to play a role in various diseases, such as arthritis, diabetes, and arteriosclerosis. ROS are generated during the process of energy production in the cell's miniature "furnaces,( read more)....
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| Extensional Rheometry
Submitter: Cambridge Polymer Group inc
CPG has expertise in extensional rheometry, which is the study of fluid flow in an extensional, rather than shear, deformation. The bulk of material processing involves a combination of shear and extension, and the flow resistance of polymeric materials can change dramatically with extensional deformation. This article summarizes a simple approach for extensional rheometric characterization.( read more)....
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| Bringing medicinal products to market in The European Union (EU)
Submitter: Pharmalink Consulting Inc
Bringing Medicinal Products to the European Union Market
By Dr. Jan van der Weide
Pharmalink Consulting Ltd.
Introduction to the European Union
The European Union (EU) is a supranational and intergovernmental union of twenty-seven states in a category of its own. It was established in 1992 by the Treaty on European Union (The Maastricht Treaty), and is the de facto successor to the six-member European Economic Community founded in 1957. Since then new accessions have raised its number of member states, and competences have expanded.
The EU is one of the largest economic and political ( read more)....
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| HERBAL MEDICINAL PRODUCTS: Quality, Safety and Efficacy considerations
Submitter: Pharmalink Consulting Inc
HERBAL MEDICINAL PRODUCTS: Quality, Safety and Efficacy considerations
Dr Jung Wing Wan, Pharmalink Consulting Inc.
Dr Jung Wing Wan of Pharmalink Consulting Ltd ponders the quality, safety and efficacy considerations of herbal products, and examines the development of regulations inside and outside Europe.
Information about the author.
Dr Jung Wing Wan is currently a regulatory project manager for Pharmalink Consulting Inc., having worked on a number of European regulatory projects with multinational pharmaceutical clients. Prior to joining Pharmalink Consulting in 2004, he worked f( read more)....
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| "Future Trends of the GMP's in Japan - based on ICH Guidelines and related activities",
Submitter: Expert Validation Consulting, Inc.
If you have tried to get a copy of the current GMP's in Japan, you may have noticed the difficulties and the confusion that is existent in this area. Most of the documents that you can find, and will have to pay for, are translations that are, at the very least, difficult to understand. These translations are being supplied by private entities/companies and you will not find the official MLHW website to be helpful in finding copies of the GMP's or even a reference/link to a location/site to find them. Not only you are required to pay a substantial amount for these translations but most of the ( read more)....
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| A Practical Guide to Applying Impact and Risk Concepts to
Submitter: Expert Validation Consulting, Inc.
INTRODUCTION
In recent years, the Food and Drug Administration (FDA)-regulated industry has been listening to agency representatives and consultants talking about the need to implement a risk-based approach to decision-making processes. I totally agree with the need to implement this "common-sense" approach, but my question is this: Is this actually a new approach?
Industry personnel have been considering risk in everyday decisions, but have not realized or documented these decisions properly. I think that the key issue here is formal documentation. In the future, the industry must foc( read more)....
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| RECENT FDA AND INTERNATIONAL REGULATORY EFFORTS AFFECTING FACILITY AND UTILITY SYSTEMS DESIGN AND QUALIFICATION
Submitter: Expert Validation Consulting, Inc.
Introduction
It is clearly recognized that the use of adequate facilities and utility systems has a critical effect on our capacity to produce products, which will consistently meet the pre-defined specifications. The adequate design of such facilities and ancillary systems is vital to the overall success of any manufacturing process/operation.
The harmonization of the compliance requirements established by regulatory agencies around our global industry is an on-going reality. It will be a continuous process and may take a few more years to represent a tangible difference but it can( read more)....
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| Top 10 Tips for Safely Handling and Using Gas Cylinders
Submitter: A. Cafferty, Scott Gas
Not every one needs to know that fluorine will violently ignite many substances, that silane burns on contact with air, or that ammonia will decompose thermally into twice its volume. But if you work with specialty gases, this information is essential. Safety must always be a primary goal when working with specialty gases -safety and knowledge go hand-in-hand.
To improve your chances of preventing hazardous accidents, follow these Top 10 Tips for safely handling and using gas cylinders:
1. Appropriate firefighting, personnel safety and first aid equipment should always be available in( read more)....
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| Concordance of MBL Protein Concentrations, Functional Activities and Genotypes in a Healthy Control Population
Submitter: IBT Reference Laboratory
http://www.ibtreflab.com/library/PDF/2005AAAAIPosterMBL.PDF( read more)....
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| Abstract Presented at the 5th Meeting of the European Society for Chlamydial Research
Submitter: IBT Reference Laboratory
http://www.ibtreflab.com/library/PDF/EuropeanCPNConference2004.PDF( read more)....
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| Are Chlamydia pneumoniae and Mycoplasma pneumoniae Important Etiological Agents of Respiratory Tract Infection in a Family Practice Setting?
Submitter: IBT Reference Laboratory
http://www.ibtreflab.com/library/PDF/2004AAAAIPoster.PDF( read more)....
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| Preventing specimen degradation
Submitter: Stephen Zweig, Clinisense
Many clinical samples can deteriorate during shipment and storage, due to storage at improper time and temperature. CliniSense is introducing a new electronic chip technology, called the "LifeTrack" programmable time-temperature monitor, which can detect this type of problem. The LifeTrack chip can be programmed with an analyte's time-temperature sensitivity curve. The chip then stays with the analyte during storage and shipment, and continually computes if the analyte's time-temperature history has been acceptable.( read more)....
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| New Approaches for Assessing Conditioning and Quantifying Silicone Deposition on Hair
Submitter: STERIS Isomedix Services
In this technical paper, Dow Corning scientists present results from deposition evaluations and analytical studies that show promise for the creation of hair care products.( read more)....
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| An Analytical Method for Adsorbed Soil Gas Hydrocarbons (SGH) to Depict Anomaly Patterns over Various Types of Deeply Buried Deposits
Submitter: Activation Laboratories Ltd.
Geochemical Actlabs & Geosoft (915 KB)
Interactive Demo - Integrating Exploration Geochemistry Application Data
A "Do It Yourself" guide to verifying geochemistry assays; this interactive demo shows you how to verify geochemistry assays using Geosoft's Chimera Exploration Geochemistry software. We recommend that all customers with geochemical data adopt a similar QC procedure.
( read more)....
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| STERILITY AND FUNDAMENTAL REQUIREMENTS OF STERILE PRODUCTS
Submitter: Dr. Janice Cacace, p Formulate
What is sterility?
Sterility is the total absence of pathogens in a finished sterile product.
Sterile products include: parenterals (injectables), ophthalmics, inhalation aerosols, and their administration devices.
One of the first steps in manufacturing a sterile product is the use of rigid aseptic procedures in a well designed controlled clean room environment.
Clean rooms are constructed, and maintained to prevent environmental contamination during manufacture.
Includes:
o smooth walls and floors
o nonporous (e.g., stainless steel) counters
o Clean air - most important com( read more)....
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| LTQ FT MS Review
Submitter: Keiji Asada , JCL Bioassay, Inc.
JCL Bioassay, Inc. has recently purchased LTQ FT MS by Thermo Electron Corporation. This system can assist in toughest analytical challenges in metabolic studies, proteome analysis, pharmaceutical discovery, and all other applications demanding rigorous structural characterization. For more information, please contact 847-866-0410. ( read more)....
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| Solving the Universal Vulnerability and Liability Problems
Submitter: Nova Biologicals, Inc.
NOVA WHITE PAPERS
Solving the Universal Vulnerability and Liability Problems
of Public Water Systems
Paul J. Pearce, PhD
Dear Reader:
In the homeland security era, public water systems face an entirely new set of vulnerability and liability problems.
A new class of services and products may be the solution to these problems.
In compliance with the Bioterrorism Act of 2002 (Public Law 107-188), many public water systems have completed their vulnerability assessments (VAs). According to state and federal authorities, the VA process has identified four (4) universal vulnerab( read more)....
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| Quality Organizations Provide for a Unique Learning Experience
Submitter: Northview Pacific Laboratories
By Farrah N. Khan, CQA, RQAP-GLP
Northview Pacific Laboratories' Quality Assurance Department is taking an active role with several quality organizations. New systems, processes and ideas are always being introduced in the world of quality and it isn't an easy task to keep on top of all of them. One way that Northview keeps on track is to stress the importance of continued education.
Our QA staff are not only members, but active participants in quality organizations such as:
American Society for Quality (San Francisco Section, Silicon Valley Section, Golden Gate Section)
Society for Q( read more)....
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| Supplement 8 of USP 23 Serves As A Guide For Establishing A Microbial Monitoring Program
Submitter: BEC Laboratories, INC.
At BEC Labs, we are often asked to help customers define environmental sampling plans for their manufacturing facilities. In doing so, we now refer them to Supplement 8 of USP 23, Section 1116, Microbiological Evaluation of Clean Rooms and Other Controlled Environments. Following is a summary of the informational chapter, which addresses how to establish, maintain, and control the microbiological quality of a controlled environment.
Cleanrooms have traditionally been classified using air cleanliness standards defined by the number of airborne particles. However, there is not always a correl( read more)....
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| Method Development & Validation
Submitter: Chemir Analytical Services
A pharmaceutical company required a full set of validated analytical procedures in order to proceed through clinical trials towards FDA approval. Chemir Analytical Services developed and validated chromatographic methods to assess the quality of the materials, including determination of physical properties and levels of impurities. The detailed report was satisfactory for FDA review.
( read more)....
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| | New-age Paint Thickening & Rheological Additives : Solvitex & Solvizen
Submitter: Mr. R. S. Subramanium
For Paint Manufacturers worldwide, there has come a radical new development in the legion of Thickening Agents & Colloidal stabilizer for Aqueous Latex Paints. So far most of the companies producing aqueous Paint emulsions, the most preferred thickening agent was Hydroxy ethyl cellulose (HEC). The HEC based thixotropic additives is produced by some of the renowned multi-national companies such as Hercules, Akzo Nobel & Dow.
Here we refer to a Biopolymer based on Polysacchride derived from controlled derivatisation process from plant origin. The product developed by Asian Trade Link Chemica( read more)....
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| Using Contract Services Wisely:
Submitter: Alliance Technologies, LLC
Contract services are a means to boost your productivity and capabilities without adding permanent capabilities. Finding the right outsourcing partner should reward you with a strategic alliance for your business. Finding the wrong partner will slow your progress and prevent you from reaching your potential.
A couple of simple questions will move you on your way to finding a laboratory that supplements your efforts to develop a product, maintain quality, understand the chemistry, or accelerate your expansion.
1. Know what you need...
Ask your analytical or contract rese( read more)....
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| | Contract Pharma Annual Meeting Review
Submitter: Raymundo Sison
The 2nd Contract Pharma Annual Meeting, sponsored by Contract Pharma Magazine was held Sept. 25-26 in Edison, NJ. Attendance improved over the first year with more industry professionals participating in a series of seminars and an exhibit hall. The focus of the show was weighted more heavily towards the business and operations environment. Less emphasis was placed on science and technology applications, which are typically more at home at DIA, CRS, ISPE and AAPS. The show and the contract industry are continuing to evolve in a dual effort to promote and serve themselves.
Without any de( read more)....
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| | Labeling of Laboratory Solutions
Submitter: Global Regulatory
In order to maintain GMP compliance (Good Manufacturing Practices, 21CFR211), ensure that all solutions prepared in your lab are labeled with the the prep date, expiration date, initials of the person preparing the solution, the identity of the solution and the concentration. You will be the guaranteed recipient of an observation (which may land on a 483!) during a regulatory or customer inspection of your lab if improperly labeled solutions are observed.
To learn more about lab audit services, and preventive actions that can be taken in your lab, contact us at admin@ContractLaboratory.com.( read more)....
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| | Improving your Lab Resume
Submitter: GMP Audit
Join a Professional Organization. . Joining a professional organization shows that you have interest in staying current with what's going on in your industry. List the professional organizations that you belong to on your resume.
2 - Add detailed descriptions of types of testing and techniques that you have used and are familiar with.
3 - Modify your resume to fit the job description that you are applying for. Highlight the areas in your career development that meet each requirement of the job you're interested in.
4 - List workshops and training that you have attended as a part of yo( read more)....
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| | Auditing
Submitter: GMP audit
1 - Audit all contract laboratories that perform testing for your company. You are responsible for all of the work that your contract laboratories perform for you. It is very important to audit labs that are listed in product submissions to the FDA as the FDA may inspect those labs in the process of approving your product. If you are not confident in your auditing skills, ContractLaboratory.com provides 3rd party laboratory audit services. Contact us at admin@ContractLaboratory.com for more information.
2 - When auditing a lab, request all copies of state, local, federal agency inspection r( read more)....
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| | Writing SOPs
Submitter: Global Regulatory
Make sure that SOPs are written by knowledgeable personnel and clearly describe all steps in a manner that is easy to understand.
If you need help writing operating procedures for your lab you may submit a project request on the ContractLaboratory.com 'Outsource' project page, or check the 'Events' page for an SOP writing workshop that you may want to attend.( read more)....
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| Laboratory Data Errors and Corrections
Submitter: Global Regulatory
If your lab, or your customers' samples, are regulated by the Food and Drug Administration (FDA), do not obscure or erase original laboratory data entries when making corrections. Instead, place one single line through the incorrect information, write the new information, date the correction, and initial or sign your name by the correction. You must also provide an explanation for why the correction was necessary. The explanation will make it easier for you to remember and describe the actual situation to an auditor during an inspection that is months or years away from the time that the corr( read more)....
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| | Recording of Laboratory Data
Submitter: GMP Audit
If your laboratory, or your customers' samples, are regulated by the Food and Drug Administration (FDA), document all data entries with indelible ink. Other inks will run or smear if documentation gets wet (easy to accomplish in the lab!) and your data will be obscured. Clear and readable data entries are very important.
If your lab needs training on documentation practices, or a documentation audit performed, ContractLaboratory.com offers laboratory audit services and on-line consulting to help keep your lab in compliance.( read more)....
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| Passwords for Computerized Instruments
Submitter: Global Regulatory
If your firm is regulated by the FDA, develop an operating procedure (SOP) for assigning, changing, and choosing passwords for computer systems. Check the computer validation guidelines available at www.FDA.gov for information on controlling entry to and use of computerized instruments.( read more)....
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| Quality Agreements and Quality Contracts
Submitter: Global Regulatory
If your firm is regulated by the FDA, develop Quality Agreements or Quality Contracts with your contract laboratories.( read more)....
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| URINARY EXCRETION OF THREE NUCLEIC ACID OXIDATION ADDUCTS AND ISOPROSTANE F2a MEASURED BY LIQUID CHROMATOGRAPHY MASS SPECTROMETRY IN SMOKERS, EX-SMOKERS, AND NONSMOKERS
Submitter: Kronos Science
Abstract-Quantification of 8-iso-prostaglandin F2a (8-iso-PGF2a) has been suggested to be a reliable indicator of lipid peroxidation that may be related to in vivo free radical generation, oxidative damage, and antioxidant deficiency. We have developed a LC-MS/MS method to quantify 8-iso- PGF2a and its dinor metabolite, 2,3-dinor-8-iso-prostaglandin F2a (2,3-dinor-8-iso-PGF2a), in human urine samples. After an initial purification step using an automated C18 solid phase extraction procedure, the urine sample was injected directly into a liquid chromatography (LC) system and detected with tande( read more)....
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| Polymer Materials Selection for Radiation-Sterilized Products
Submitter: STERIS Isomedix Services
Choosing the right polymer for a radiation-sterilized device requires an understanding of radiation effects, manufacturing processes, and the product's intended use.( read more)....
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Submitter:
( read more)....
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| | Laboratory Notebooks
Submitter: Global Regulatory
For compliance to FDA, instruct all lab technicians not to tear pages out of their notebooks.( read more)....
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| | FDA Inspections
Submitter: Global Regulatory
If the FDA comes for an inspection, make sure you are shown their credentials.( read more)....
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| | Selecting a Contract Laboratory
Submitter: Global Regulatory
For critical testing, audit a lab prior to selecting a contract laboratory.( read more)....
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| | Effective Use of Contract Laboratories
Submitter: Global Regulatory
To best use contract laboratories, appoint one person in your company as the firm contact( read more)....
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| | Cosmetics & Toiletries - Global Outsourcing & Private Label Manufacturing
Submitter: Rasik Botadra
After recent globalization and change in policies the opportunities for manufacturers & exporters have widen. Today we can say that the producers are coming-off their age from traditional methods. The developments are becoming trend setting. The Manufacturers are versatile to cope up with the vibrant consumer behavior.
The globalization in terms of foreign trends & acceptability has penetrated finely into the Indian buying market and so is the Local manufacturer's struggle to captivate the opportunities by matching the same trends & international qualities.
The practice of quality cont( read more)....
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| Kronos Science Laboratory Fatty Acid Poster
Submitter: Kronos Science Laboratory
Kronos Science Laboratory Fatty Acid Poster
http://www.contractlaboratory.com/www/labuploads/Kronos_ Fatty_Acid_Poster.pdf( read more)....
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