Topic: Good Manufacturing Practices
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What are good manufacturing practices?
GMP are that part of quality assurance which ensures that products are consistently produced and controlled according to quality standards. They are designed to minimize the main risks involved in pharmaceutical production that cannot be el... Read More »
Source: http://www.who.int/medicinedocs/en/d/Jh3009e/18.html
How good manufacturing practice requirements are different
Good manufacturing practice (GMP) is an important factor in assuring that your cosmetic products are neither adulterated nor misbranded. However, no regulations set forth specific GMP requirements for cosmetics. In contrast, the law require... Read More »
Source: http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformat...
How concerning are the practices of manufacturers in China?
It is worrisome, and I think this is why the FDA put their presence in China, because of the fact that we’re relying upon them as a producer. Active pharmaceutical ingredients, for example, and a certain number of medical devices, and maybe... Read More »
Source: http://www.ivanhoe.com/channels/p_channelstory.cfm?storyid=21337
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Study up on ISO 9001: Source(s): http://praxiom.com/iso-9001.htm
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Source: http://answers.yahoo.com/question/index?qid=20060918230352AAQgu5l
The GMP requirements are part of the Quality System Regulations. They require that domestic or foreign manufacturers have a quality system for the design, manufacture, packaging, labeling, storage, installation, and servicing of finished me...
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Source: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVD...
The GMP regulations for medical devices were first authorized by the Medical Device Amendments of 1976 under section 520(f) of the act. In July 1978, FDA published final regulations prescribing GMP requirements for the methods used in, and ...
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Source: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Gui...
OCP has published a draft guidance document for Current Good Manufacturing Practices for Combination Products . The guidance is posted on the Combination Products section of the FDA website. OCP intends to publish a proposed regulation to ...
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Source: http://www.fda.gov/CombinationProducts/AboutCombinationProducts/u...
FDA recommends that manufacturers of combination products discuss with the Agency how current good manufacturing practice regulations apply to their products. Manufacturers are encouraged to seek FDA comment on their implementation of curre...
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Source: http://www.fda.gov/RegulatoryInformation/Guidances/ucm126198.htm
ISO9002
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Source: http://wiki.answers.com/Q/What_engineering_practice_is_applied_to...
