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Topic: GMP


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In the News (Thu 24 Dec 09)

  
  Good Manufacturing Practices (GMP) / Quality Systems (QS)
GMP exemptions are codified in the Classification Regulations 21 CFR 862 to 892.
Manufacturers should be aware of the GMP exemption status of their devices.
Component manufacturers are not routinely scheduled for GMP inspections; however, FDA encourages them to use the QS regulation as guidance for their quality system.
www.fda.gov /cdrh/devadvice/32.html   (2903 words)

  
  GNU Multi-Precision Library - Wikipedia, the free encyclopedia
GMP aims to be faster than any other bignum library for all operand sizes.
GMP is part of the GNU project (although the fact that its website is not on gnu.org might cause confusion), and is distributed under the GNU LGPL.
GMP is used for integer arithmetic in many computer algebra systems.
en.wikipedia.org /wiki/GNU_Multi-Precision_Library   (385 words)

  
 Good Manufacturing Practice - Wikipedia, the free encyclopedia
In the United States GMPs are referred to as "cGMPs" or "current Good Manufacturing Practices" GMP is a term that is recognised worldwide for the control and management of manufacturing and quality control testing of pharmaceutical products.
Since the publication in 1999 by the International Conference on Harmonization (ICH) of "GMPs for Active Pharmaceutical Ingredients", GMPs also apply in those countries and trade groupings that are signatories to ICH (the EU, Japan and the USA) and other countries who adopt ICH Guidelines (e.g.
GMP is designed to help assure the quality of drug products by ensuring several key attributes: including correctness and legibility of recorded manufacturing and control documentation.
en.wikipedia.org /wiki/Good_Manufacturing_Practice   (618 words)

  
 The GNU MP Bignum Library
GMP is a free library for arbitrary precision arithmetic, operating on signed integers, rational numbers, and floating point numbers.
GMP is carefully designed to be as fast as possible, both for small operands and for huge operands.
GMP is brought to you by a team listed in the manual.
www.swox.com /gmp   (1936 words)

  
 Inspections - GMP Q&A on Active Substances
Section 5.25 of the GMP Guide requires starting materials to be purchased from approved suppliers and about whom the manufacturer has a particular and thorough knowledge.
However, these alone cannot fulfil the statutory obligations of the manufacturing authorisation holder or the requirements of section 5.25 of the GMP Guide, but the results of inspections, may be used together with other supporting information in a risk-based approach by the manufacturer in establishing priorities for its own audit programme of active substance suppliers.
Importers are already obliged to ensure the third country manufacturer complies with standards of GMP equivalent to those of the European Community and should have established arrangements in line with Chapter 7 of the Guide.
www.emea.eu.int /Inspections/GMPfaqAS.html   (813 words)

  
 What Is GMP?   (Site not responding. Last check: 2007-10-11)
GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors.
GMP requirements are largely common sense practices which will help your company better itself as it moves toward a quality approach using continuous improvement.
GMP 101 is a great introduction to the concepts of GMP and the reason behind it.
www.gmp1st.com /gmp.htm   (590 words)

  
 GNU MP 4.1 - GMP Basics
GMP lets you use the same variable for both input and output in one call.
When a GMP variable is used as a function parameter, it's effectively a call-by-reference, meaning if the function stores a value there it will change the original in the caller.
This version of GMP is upwardly binary compatible with all 4.x and 3.x versions, and upwardly compatible at the source level with all 2.x versions, with the following exceptions.
www.math.umn.edu /systems_guide/gmp-4.1/gmp_4.html   (3309 words)

  
 About GMP
Today GMP is recognized as a premier worldwide supplier of specialty tools and equipment for the outside plant marketplace.
GMP product applications include the placement of copper conductor, coaxial and fiber optic cable both aerially and underground.
Accepted as industry standards are the GMP aerial cable lashing machines, Adams® continuous duty winches and fiber optic cable pullers.
www.gmptools.com /nf/about.htm   (631 words)

  
 GMP Prepared For Y2K
GMP expects to meet the preparedness standards set by the electric industry and industry regulators, which call for the electrical system to be Y2K compliant by July 1, 1999.
GMP has been replacing or renovating systems for five years, testing each upgrade as it was completed.
GMP personnel also will be on hand and ready to "cold start" the Company's own generators located at various sites if the state or region should experience a widespread interruption of service.
www.gmpvt.com /y2k/gmpy2k.htm   (995 words)

  
 Good manufacturing practice for therapeutic goods
The acronym GMP is used internationally to describe a set of principles and procedures which, when followed by manufacturers of therapeutic goods, helps ensure that the products manufactured will have the required quality.
A basic tenet of GMP is that quality cannot be tested into a batch of product but must be built into each batch of product during all stages of the manufacturing process.
GMP audits of overseas manufacturers who supply therapeutic goods to Australia are also undertaken by the TGA, particularly where alternative acceptable evidence of compliance to an equivalent Code of GMP or Quality System is not available.
www.tga.gov.au /docs/html/webgmp.htm   (1045 words)

  
 Statue of Liberty & Ellis Island NPS | About the Plan - The General Management Plan
This GMP will be a forward-looking document outlining steps for protecting resources, providing improved visitor experiences, and improving operations at Liberty and Ellis Islands.
Each national park creates a GMP every 20 years or so, or when there are major changes in park development or direction.
In this case, the need for the 2006 GMP is inspired by a little bit of both.
www.libertyellisplan.org /gmp.asp   (233 words)

  
 GMP Capital Trust
GMP Private Client is a full service investment firm focused on the affluent client and their financial objectives.
GMP Securities has Canadian offices in Toronto, Calgary, and Montreal and a representative office in Geneva, Switzerland.
GMP Securities is a member of the Toronto, Montreal and TSX Venture stock exchanges, the Canadian Investor Protection Fund and the Investment Dealers Association of Canada.
www.gmpcapitaltrust.com /about/default.asp?loc1=about   (392 words)

  
 GMP Systems - GMP QS training auditing consulting consultant FDA
While GMP compliance is a given, the integration of GMP into the company's business strategy is essential for a successful, maintained quality system.
GMPS makes every effort to let employees better understand their role, and to let them know that they are important to the life of another human being, and that they have a major responsibility to protect their patients.
GMP Systems LLC is a member of ASQ, APICS and serves as a consultant to the Interactive Certified Appraisers Network.
www.gmp-systems.com /index.html   (282 words)

  
 Sleeping Bear Dunes National Lakeshore - General Mgmt. Plan / Wilderness Study (U.S. National Park Service)
The new GMP will help the National Park Service continue to preserve the Lakeshore in its natural setting and protect it from developments and uses which could destroy its scenic beauty and natural character, yet still provide a balanced range of visitor experiences and recreational opportunities, from drive-to beaches to solitary hikes.
The GMP alternatives that are ultimately carried forward into the draft GMP/WS/EIS document (Summer 2008) are referred to as the “draft alternatives” (no longer preliminary) and the draft document will then be followed by the final GMP/WS/EIS by the end of 2008.
We remain committed to developing a new GMP and wilderness proposal that will ensure preservation and protection of the natural and cultural resources entrusted to our care in a way that provides ample and varied visitor experiences and recreational opportunities.
www.nps.gov /slbe/parkmgmt/gmphome.htm   (926 words)

  
 GMP Securities L.P.
GMP Capital Trust and its subsidiaries and affiliates ("GMP") are committed to keeping your personal information confidential.
The GMP Privacy Policy applies to all your dealings with us regardless of the mode of communication, whether in person, by telephone, fax, online, or regular mail.
All GMP personnel sign a confidentiality agreement which governs their treatment of all personal information.
www.gmpsecurities.com /GMPCapitalPrivacy.asp?printVersion=yes   (1765 words)

  
 Introduction to cyclic GMP
Synthesis and degradation of the cyclic GMP molecule.
In fact, living cells has been using cyclic GMP since the ancient times; this compound and its synthetic enzyme (guanylyl cyclase) have been detected throughout the animal kingdom, plants and even in bacteria.
On the other hand, although cyclic GMP was also discovered very early (it was discovered in urine in 1963) and considered a second messenger since 1970, the regulation of its synthesis has remained a mystery until recently.
cgmp.blauplanet.com /intcgmp.html   (267 words)

  
 GMP Training
There are different GMPs for the various industries regulated by the FDA.
Failure of firms to comply with GMP regulations is a federal offence and can result in recall, seizure, fines, and jail time.
You are required to implement processes and procedures that comply with the requirements listed in the applicable GMP before you can release your product, you can be audited by FDA inspectors at anytime.
www.caliso9000.com /GMP_consulting.html   (844 words)

  
 UMI | Federal Data Agenda: Gross Metropolitan Product   (Site not responding. Last check: 2007-10-11)
The structure of an on-line GMP data tool would be analogous to the existing GSP data tool.
If GMP proves feasible, in fiscal year 2007 BEA will prepare prototype GMP estimates for selected years and industries, and provide a prototype methodology statement for comment from the user community.
GMP can be estimated in either of two ways.
www.brookings.edu /metro/umi/gmp.htm   (439 words)

  
 GMP Services Inc Statesboro Georgia (GA), Web Design, Web Hosting, PC Computer Repair, PC Computer Repair, Networking, ...   (Site not responding. Last check: 2007-10-11)
GMP Services is a multi-faceted company that thrives on innovation and creativity.
GMP Services has been in business since 1996 and offers services to several industries including publishing, printing, design, marketing, advertising, information technology, computers, networking, e-commerce, retail and Internet.
GMP Services does service businesses and home users outside of the Statesboro Ga area including: all of Bulloch County, Bryan County, Chandler County, Chatham County, Effingham County, Evans County and Screven County.
www.gmpservices.com /Home.aspx   (414 words)

  
 WHO | GMP Question and Answers
GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff.
GMP prevents errors that cannot be eliminated through quality control of the finished product.
Without GMP it is impossible to be sure that every unit of a medicine is of the same quality as the units of medicine tested in the laboratory.
www.who.int /medicines/areas/quality_safety/quality_assurance/gmp/en   (509 words)

  
 GMP - Good Manufacturing Practice
GMP Annex 3 “Manufacture of Radiopharmaceuticals” : Draft revision for public consultationThe annex has been revised in the light of new GMP requirements for actives substances used as starting materials (GMP Part II).
The Compilation is a collection of GMP inspection-related procedures and forms agreed by the GMP inspectorates of all Member States and designed to facilitate administrative collaboration, harmonisation of inspections and exchange of inspection-related information.
Until this comes into force requirements for GMP for active substances and hence the applicability of this guideline will not be mandatory in the EU.
ec.europa.eu /enterprise/pharmaceuticals/pharmacos/gmp_doc.htm   (4381 words)

  
 A Tour of NTL: Using NTL with GMP
The use of GMP as the primary long integer package is the preferred method of using GMP.
The use of GMP as a supplemental long integer package is intended primarily for backward compatability.
When building NTL with GMP, you have to tell NTL that you want to use GMP as the primary long integer package, and where the include files and library are.
www.shoup.net /ntl/doc/tour-gmp.html   (1284 words)

  
 GMP A4 Avant Quattro - Features - European Car Magazine   (Site not responding. Last check: 2007-10-11)
It's one of the most inspiring wagons to drive, even in stock trim--and massage in a little aftermarket craftsmanship, and the package is all the more irresistible.
The appeal is clearly demonstrated by this 2002 model prepared by GMP, a longtime tuner of VAG automobiles.
GMP has been in this game for a long time and continues to develop rational, well-rounded performance cars.
www.europeancarweb.com /features/0405ec_gmp_a4_avant_quattro   (320 words)

  
 GMP Quality Seal Reaches Supplement Shelves
Many quality issues are included in the audit, such as double checking the identify of raw materials to ensure one has the correct substance, testing for the presence of heavy metals or microbials or other contaminants, and use of stability studies to determine accurate expiration dates.
The inspectors are trained to conduct GMP audits according to a checklist and performance rating system developed by NNFA.
Having a solid GMP program ensures that a manufacturer is producing consistent quality -- from batch to batch, lot to lot, bottle to bottle and tablet to tablet.
www.supplementquality.com /testing/NNFA-GMP-seal.html   (433 words)

  
 Good Manufacturing Practices (GMP) - FierceBiotech
GMP guidelines establish best practices as they evolve and also provide for extensive record keeping that helps reviewers determine the best way to make a drug.
Manufacturers turn to GMP guidelines for direction on how best to perform laboratory processes such as calibrating instruments, preventing contamination, verifying drug stability, and labeling pharmaceutical products.
In addition to delineating the required characteristics of drugs, GMPs also mandate specialized training and lab environmental controls such as instructions for ensuring freedom from vermin, instructions for how to build and maintain clean rooms, directives on how to house and handle lab animals, and strict policies for compliance.
www.fiercebiotech.com /topics/manufacturing_practices.asp   (338 words)

  
 Inspections - Good Manufacturing Practice
They are developed by the GMP inspection services group and are published as Volume 4 of EudraLex by the European Commission.
The Sector is involved in co-ordinating the preparation of new and revised guidance on GMP, co-ordination of advice on the interpretation of EU GMP requirements and related technical issues, and on the development of community-wide procedures relating to GMP inspections, known as the Compilation of Procedures.
The Sector assists in the progression of MRAs (Mutual Recognition Agreements) on GMP with regulatory authorities in non- EU countries.
www.emea.eu.int /Inspections/GMPhome.html   (365 words)

  
 GMP_Hist   (Site not responding. Last check: 2007-10-11)
GMP provides service to large and sophisticated manufacturing facilities, like the IBM plant in Essex Junction, which employs some 6,000 people and makes the Power PC chip, and it serves small entrepreneurial businesses like Firerobin, which employs five people to produce hand-crafted puppets.
GMP has entered into long-term contracts with power suppliers, ensuring adequate, reasonably priced electricity for the future.
GMP has a "green" mix of energy resources, protecting the environment and protecting customers from surcharges that could be levied against polluting energy producers in the future.
www.gmpvt.com /gmphist.htm   (164 words)

  
 GMP Securities L.P.   (Site not responding. Last check: 2007-10-11)
Griffiths McBurney Corp. has an operating agreement with GMP, whereby GMP handles all trading and settlement operations required in servicing your account.
Additionally Griffiths McBurney Corp. and GMP may also disclose such non-public information to regulatory bodies and/or as required by law.
Griffiths McBurney Corp. and GMP policies and procedures ensure all non-public information disclosed to us is kept on a confidential and need to know basis at all times.
www.gmpsecurities.com /GMCorpPrivacy.asp   (190 words)

  
 GMP Labeling, Inc. - GMP and ISO Compliance made easier
GMP Labeling products help you identify components, pilot batches, raw materials, in-process materials, and areas in your laboratory and in production.
GMP Labeling System products are designed in distinctive shapes, sizes, colors and color-coded titles to prevent lost identities, mix-ups and errors.
Founded in 1987, GMP Labeling serves companies that are regulated by the FDA and/or registered for ISO 9000 standards.
www.gmplabeling.com   (174 words)

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