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	GMP - Good Manufacturing Practice
		The new “Guidance on occasions when it is appropriate for competent authorities to conduct inspections at the premises of manufacturers of active substances used as starting materials” was developed in the light of the new obligations of manufactures to ensure the application of GMP for active substances and corresponding inspection provisions for Member States.
		Annex 14 Manufacture of medicinal products derived from human blood or plasma to the EU Guide to Good Manufacturing Practice was adopted at the Ad-hoc meeting of the GMP Inspection services on the 11 February 2000.
		A draft text of Annex 6 Manufacture of medicinal gases to the EU Guide to Good Manufacturing Practice was released for industry consultation on the 23 March 2000.
	ec.europa.eu /enterprise/pharmaceuticals/pharmacos/gmp_doc.htm (4419 words)

	EPA: Federal Register: Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients ...
		Manufacturing, packaging, and holding practices can compromise safety if they fail to prevent biological, chemical, and physical contamination, or if the wrong dietary ingredients are used that present an unreasonable risk of illness or injury.
		Manufacturers of vitamins and minerals would be required to follow the sanitation, holding, and consumer complaint provisions only, they would not have to adopt manufacturing controls to ensure that products did not contain too much or too little of a vitamin or mineral.
		When determining baseline manufacturing practices, it is necessary to estimate both the practices that are used now, as well as the likely changes in manufacturing practices that will occur even in the absence of new regulations.
	www.epa.gov /fedrgstr/EPA-IMPACT/2003/March/Day-13/i5401.htm (16134 words)

	What Is GMP?
		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)

	Current Good Manufacturing Practice (Site not responding. Last check: )
		Equipment that is in the manufacturing or food-handling area and that does not come into contact with food shall be so constructed that it can be kept in a clean condition.
		All food manufacturing, including packaging and storage, shall be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, or for the contamination of food.
		Some foods, even when produced under current good manufacturing practice, contain natural or unavoidable defects that at low levels are not hazardous to health.
	www-seafood.ucdavis.edu /Guidelines/gmps.htm (4997 words)

	Pharmacos V6 - GMP (Site not responding. Last check: )
		The new “Guidance on occasions when it is appropriate for competent authorities to conduct inspections at the premises of manufacturers of active substances used as starting materials” was developed in the light of the new obligations of manufactures to ensure the application of GMP for active substances and corresponding inspection provisions for Member States.
		Annex 14 Manufacture of medicinal products derived from human blood or plasma to the EU Guide to Good Manufacturing Practice was adopted at the Ad-hoc meeting of the GMP Inspection services on the 11 February 2000.
		A draft text of Annex 6 Manufacture of medicinal gases to the EU Guide to Good Manufacturing Practice was released for industry consultation on the 23 March 2000.
	dg3.eudra.org /F2/pharmacos/gmp_doc.htm (4188 words)

	Good Manufacturing Practice - Faculty of Life and Social Sciences
		GMP courses are a joint initiative of Swinburne and SeerPharma (the therapeutic industry's leading and largest provider of technical compliance)..
		The GMP courses are designed for people currently working, or intending to work in the pharmaceutical or biotechnological sectors.
		Courses in Good Manufacturing Practices are suited to those people who wish to gain an accredited entry point into the pharmaceutical, biotechnology and medical device industries, as well as to professionals already working in these industries and seeking to advance towards senior and executive management positions.
	www.swin.edu.au /lss/goodmanufacturing/goodmanufacturing.html (404 words)

	FDA/CFSAN Cosmetic Good Manufacturing Practice Guidelines
		It is manufactured or held under insanitary conditions whereby it may have become injurious to users or contaminated with filth.
		To determine whether cosmetic firms manufacture, hold or deliver for introduction into interstate commerce cosmetics that are adulterated or misbranded, and to prevent these and other practices violating Sec.
		Buildings used in the manufacture or storage of cosmetics are of suitable size, design and construction to permit unobstructed placement of equipment, orderly storage of materials, sanitary operation, and proper cleaning and maintenance.
	www.cfsan.fda.gov /~dms/cos-gmp.html (1331 words)

	Victoria Good Manufacturing Practices (Site not responding. Last check: )
		Instruments anti controls used for measuring, regulating, or recording temperatures, pH, acidity, water activity, or other conditions that control or prevent the growth of undesirable microorganisms in food shall be accurate and adequately maintained, and adequate in number for their designated uses.
		Food-manufacturing areas and equipment used for manufacturing human food should not be used to manufacture nonhuman food-grade animal feed or inedible products, unless there is no reasonable possibility for the contamination of the human food.
		Compliance with defect action levels does not excuse violation of the requirement in section 402(a)(4) of the act that food not be prepared, packed, or held under unsanitary conditions or the requirements in this part that food manufacturers, distributors, and holders shall observe current good manufacturing practice.
	www.victoriapacking.com /gmpinfo.html (4857 words)

	Inspections - Good Manufacturing Practice
		Detailed guidelines in the form of the Guide to Good Manufacturing Practice provide interpretation of the principles and guidelines and these in turn are supplemented by a series of annexes which modify or augment the detailed guidelines for certain types of product, or provide more specific guidance on a particular topic.
		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.
	www.emea.eu.int /Inspections/GMPhome.html (365 words)

	FDA/CFSAN Cosmetic Good Manufacturing Practice Guidelines
		It is manufactured or held under insanitary conditions whereby it may have become injurious to users or contaminated with filth.
		To determine whether cosmetic firms manufacture, hold or deliver for introduction into interstate commerce cosmetics that are adulterated or misbranded, and to prevent these and other practices violating Sec.
		Buildings used in the manufacture or storage of cosmetics are of suitable size, design and construction to permit unobstructed placement of equipment, orderly storage of materials, sanitary operation, and proper cleaning and maintenance.
	vm.cfsan.fda.gov /~dms/cos-gmp.html (1307 words)

	Australian code of good manufacturing practice for medicinal products
		Annex 4 [Manufacture of veterinary medicinal products other than immunologicals] This PIC/S Annex is not adopted by the Australian Code of Good* Manufacturing Practice for Medicinal Products, 16 August 2002.
		Annex 5 [Manufacture of immunological veterinary medical products] This PIC/S Annex is not adopted by the Australian Code of Good* Manufacturing Practice for Medicinal Products, 16 August 2002.
		Annex 14 [Manufacture of products derived from human blood or human plasma] This PIC/S Annex is not adopted by the Australian Code of Good* Manufacturing Practice for Medicinal Products, 16 August 2002.
	www.tga.gov.au /docs/html/gmpcodau.htm (358 words)

	Good Manufacturing Practice - Montana Manufacturing Center
		This course offers detailed information on Good Manufacturing Practice (GMP), the standards used internationally to describe a set of principles and procedures which are applied by manufacturers of food, medical-related, and therapeutic products to ensure that products manufactured will meet required standards of quality and safety.
		This course will explore the basic tenant of GMP -- that quality cannot be tested into a product, but must be built into each product during all stages of the manufacturing process.
		GMP codes will be introduced and requirements for compliance discussed with an emphasis on product safety compliance.
	www.mtmanufacturingcenter.com /Training/gmp.htm (290 words)

	Chemskill Consulting: Good Manufacturing Practice
		The TGA have recently adopted the guidelines of GMP, as established by the Pharmaceutical Inspection Co-operation Scheme (PIC/S), as the new Australian Code of GMP.
		The Australian Code of GMP is a set of procedures and principles which, when followed by manufacturers of therapeutic and veterinary goods, help ensure appropriate quality standards are met.
		Typically all manufacturers of therapeutic and veterinary goods must follow a set quality standard of manufacturing principles and procedures to ensure consistency in product quality, safety and efficacy.
	www.chemskill.com.au /consulting/gmp.html (134 words)

	About GMP Institute
		On 1 January 2000, the GMP Institute was acquired by ISPE, an educational association consisting of more than 20,000 Life Science professionals in 75 countries.
		ISPE and the GMP Institute are bringing together more than 40 years of experience in training and education for the healthcare manufacturing industry.
		As a division of ISPE, the GMP Institute will continue to provide industry professionals with valuable GMP training that enables them and their companies to manufacture and deliver high quality products and services.
	www.gmp1st.com /gmpinst.htm (230 words)

	European Tissue Symposium - Good manufacturing practice (GMP)
		There are many different GMP systems in industrial use, covering all kinds of products, but this GMP is designed specifically for kitchen towels and napkins made from tissue paper.
		The GMP contains a table of possible hazards and suggested means of prevention for all manufacturing stages generally applied for kitchen towels and napkins.
		A comparison between the "tissue" GMP and the GMP which is part of the Council of Europe Resolution on [packaging] paper and board reveals several similarities, but also identifies differences due to the differences in specifications between the Guidelines and the Resolution.
	www.europeantissue.com /item.aspx?id=152 (439 words)

	Expert in: Biopharmaceutical Development and Manufacture
		Expert has had direct experience with GLP and GMP compliance in the development and manufacturing of biopharmaceuticals and biological products, and has complete knowledge of the relevant FDA regulations and the ability to advise on compliance.
		This covers the validation of manufacturing processes and analytical test methods in order to comply with FDA's cGMP regulations and those of Europe and the new ICH requirements for GMP for Active Principles.
		He is a visiting lecturer in GMP for biopharmaceuticals at the National University of Singapore.
	www.intota.com /viewbio.asp?bioID=765574&perID=722065 (1357 words)

	Drug Information Journal: Current good manufacturing practice design trends in active pharmaceutical ingredients ...
		It was not too long ago when the FDA agreed to use the term "API." The FDA's first guide on bulk pharmaceutical chemicals refers to the active ingredient and states that this is where validation and qualification are required.
		For that matter, there were even questions of how early in the process and to what degree GMP compliance had to be taken.
		There is a realization that APIs and final dosage forms do have a GMP commonality in that they both share in the application of the same quality principles.
	www.findarticles.com /p/articles/mi_qa3899/is_199907/ai_n8871544 (1475 words)

	AntelBio - QA - Good Manufacturing Practice
		AntelBio is in the process of complying with the Good Manufacturing Practice (GMP), 21 CFR 820 guidelines, set forth by the Food and Drug Administration (FDA).
		The GMP's stipulate requirements for the manufacturing of medical devices and incorporation of them into a quality system regulation.
		The quality system regulation includes requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices intended for human use.
	www.antelbio.com /QA/gmp.htm (110 words)

	Cleanrooms and Good Manufacturing Practice (GMP) (Site not responding. Last check: )
		An explanation of the classification of cleanrooms and the relationship to previous and existing standards along with practical suggestions for compliance is covered.
		There is also practical advice on selecting cleanroom consumables, cleaning the cleanroom and working with mini environments.
		Cleaning and disinfection of the GMP cleanroom area will be covered plus an outline of quality assurance and quality control and the expectations of validating GMP facilities, equipment and processes.
	www.bsi-global.com /Seminars/Cleanrooms/index.xalter (445 words)

	EPA: Federal Register: Current Good Manufacturing Practice for Positron Emission Tomography Drugs
		Although, as discussed in section III.B of this document, all PET drug producers have adopted some level of good manufacturing practices or SOPs, not all producers currently are fully compliant with all USP standards.
		According to the SBA, pharmaceutical preparation manufacturers with 750 or fewer employees, electromedical and electrotherapeutic apparatus manufacturers with 500 or fewer employees, drugs and druggists' sundries wholesalers with 100 or fewer employees, and for-profit hospitals, clinics, colleges, and universities with $29 million or less in revenue are considered small businesses or entities.
		Title: Current Good Manufacturing Practice for Positron Emission Tomography Drugs Description: In accordance with the Modernization Act, the proposed rule would establish CGMP requirements for PET drugs.
	www.epa.gov /fedrgstr/EPA-IMPACT/2005/September/Day-20/i18510.htm (15603 words)

	GMP, Good Manufacturing Practice, SOP
		Our high quality Good Manufacturing Practice (GMP) documents are automatically sent to your e-mail address as soon as the order and payment processes have been completed.
		Our company is the first pharmaceutical Good Manufacturing Practice (GMP) consulting service to be based entirely on the Internet.
		We work closely with experienced and highly skilled professional GMP experts from around the world, allowing you to benefit from their wide-ranging knowledge and expertise.
	www.gmp-online-consultancy.com (332 words)

	Good Automated Manufacturing Pracice (GAMP) (Site not responding. Last check: )
		It provides guidance to the suppliers of those automated systems on their development and maintenance by following good practice, and assists the suppliers in producing the necessary documentation required to support validation.
		It helps suppliers ensure that systems are developed according to good practice, and to provide documentary evidence that their system meet the agreed specification.
		Contains Good Practice definitions, and guidance on application of Good Practice to various systems.
	www.labcompliance.com /regulations/gamp.htm (408 words)

	Code of Federal Regulations: 21 CFR 110 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding ...
		Compliance with this requirement may be accomplished by providing: (1) Hand-washing and, where appropriate, hand-sanitizing facilities at each location in the plant where good sanitary practices require employees to wash and/or sanitize their hands.
		(c) Equipment that is in the manufacturing or food-handling area and that does not come into contact with food shall be so constructed that it can be kept in a clean condition.
		(2) All food manufacturing, including packaging and storage, shall be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, or for the contamination of food.
	www.fortinlaw.com /21_CFR_110.htm (5102 words)

	SeerPharma \| Good Manufacturing Practice
		is the systematic application of psychological research on human behaviour to the problems of GMP in the workplace.
		Given that the majority of non-compliance observations result from human error, improving GMP performance can only be achieved by systematically focusing on behaviours in the workplace.
		The courses are designed to ensure the learner explores the application of GMPs in a dynamic and stimulating environment.
	www.seerpharma.co.uk (264 words)

	RBAI-Pre-HACCP Good Manufacturing Practice Course
		Good Food Manufacturing Practice Procedures (GMP's) are essential for the safe manufacture, processing and handling of food and must be put in place before HAaCCP is effectively addressed.
		In any food company, to be effective, these Pre-HACCP Good Manufacturing Practice programmes need to be documented as part of the FoodSafety Management System.
		Understand Pre-HACCP Good Manufacturing Practice programmes and their vital role in preparing for effective HACCP implementation.
	www.rbai.ie /rbai02.asp (479 words)

	Good Manufacturing Practice (Site not responding. Last check: )
		CRA 1998; 14:4 A practical approach to the retention of trial materials.
		CRA 2004; 132:5 Revision of Annex 1 of EC GMP.
		CRA 2005; 147:8 Authorisations for manufacturing and import.
	www.canarybooks.com /GMP_web.htm (288 words)

	[No title]
		Gaining insight in the various aspects to the regulations of good manufacturing practice based on Dutch and European rules (Volume 4) and the impact these regulations have on the actual production of drugs.
		On the basis of Annex 13 (Manufacture of investigational medicinal products) important aspects like documentation, the determination of specifications, procedures and change control will be discussed.
		On the 2nd day of the course the participants will develop a production process and validate it under GMP to prepare this process for inspection.
	www.rug.nl /Guide/education/methodology/courses/Goodmanufacturing (172 words)

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