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What is the difference between GMP & cGMP?

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Question ajoutée par panjabrao deshmukh panjab , production chemist , schon pharmaceutical limited
Date de publication: 2014/11/11
Rami Assaf
par Rami Assaf , loading and Storage Operations Supervisor , Arab Potash Company

I think answer of Mohamed Elsafty where give you your demand & thanks for him

 Mohamed Elsafty

Mohamed Elsafty مدير إدارة التخطيط at مجموعة شركات يونيفرسال

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Mohamed Elsafty
par Mohamed Elsafty , مدير إدارة التخطيط , مجموعة شركات يونيفرسال

GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act. These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors. This in turn, protects the consumer from purchasing a product that is not effective or even dangerous

GMP is also sometimes referred to as "cGMP". The letter "c" stands for "current," reminding manufacturers that they must employ technologies and systems that are up-to-date in order to comply with the regulation

GMP guidelines are very broad in nature and cover all aspects of business such as personnel qualifications, cleanliness, book keeping, systems and procedures, equipment, and so on. In fact, GMP has helped in uplifting the standards of healthcare products and has strict regulations that accepting countries must adhere to. Companies that fail to comply with the provisions of GMP have to face serious consequences that include fines, jail, and recall of products and so on

The challenge is related to several different potential reasons such as the following:

  • Difficulty of GMP guideline interpretation: what is written? what is really meant/expected?
  • Difference between national GMP guidelines and international guidelines
  • Difference in cultural understanding of the GMP guideline

Mohamed Ahmed Mohamed Moussa
par Mohamed Ahmed Mohamed Moussa , Operation manager. , Wofoor Company for trading and industrial Ltd.

GMP = Good Manufacturing Practices                                                                               cGMP = Current Good Manufacturing Practices. we can say updated GMP practices for the current/present year onwards                                                                                             As 'c' stands for Current, As years and years has been passed till date from the actual implementation of GMP guidlines which get updated time to time and therefore manufacturer should update these changes by incorporating the cGDP, cGLP meet complience to regulatory.

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