By GMP (Good Manufacturing Practice, property manufacture practice) one understands guidelines for the quality assurance of the and - environment in production about medicaments, active substances and medicine products. In the pharmaceutical production the quality assurance plays a central role, since variations in quality can have direct effects here on the health of the consumers. A GMP fair quality management system serves for to the guarantee of the product quality and fulfilment of the requirements of the health authorities obligatory on the marketing.

Appropriate guidelines for the medicament range are for example by the European commission, by the Pharmaceutical Inspection Convention (PIC), by the US-American FDA as well as on global level by international the Conference on Harmonisation OF Technical requirement for Registration OF Pharmaceuticals for human Use (I) (only for active substances) provided.

The EEC-GMP-manual for human and animal medicaments concretizes the guideline 2003/94/EG to the definition of the principles and guidelines of good manufacture practice for human medicaments and for test preparations intended for application with humans as well as the guideline 1991/412/EWG to the definition of the principles and guidelines of good manufacture practice for animal medicaments and is arranged as follows:

Part I

• Chapter 1 - Quality management
• Chapter 2 - Personal
• Chapter 3 - Area and mechanisms
• Chapter 4 - Documentation
• Chapter 5 - Production
• Chapter 6 - Examination
• Chapter 7 - Production and examination on behalf
• Chapter 8 - Complaints and product recalls
• Chapter 9 - Self inspections

Part II

• GMP requirements for active substances

Annexes

• 1 - Production of sterile medicaments
• 2 - Production from biological medicaments to application with humans
• 3 - Production of radioactive medicaments
• 4 - Production of animal medicaments (except animal vaccines)
• 5 - Production of animal vaccines
• 6 - Production of medical gases
• 7 - Production of vegetable medicaments
• 8 - Samples of output and wrapping material
• 9 - Production of liquid, halfliquid Darreichungsformen as well as ointments
• 10 - Production of aerosols
• 11 - Computer-assisted systems
• 12 - Use of ionized jets for the medicament production
• 13 - Production of test preparations
• 14 - Production of products, which are won from human blood or human plasma
• 15 - Qualification and validating
• 16 - Load certifying and - release by the adept person
• 17 - Parametric release
• 18 - (transferred in part II)
• 19 - Reference and resetting sample

See also

• GLP Good Laboratory Practice
• Procedure documentation

Related links

• Information of the WHO (English)
• GMP guideline of the European commission for human medicaments (German)
• GMP guidelines of the FDA (English)
• Guidelines which I (English)

Articles in category "Good Manufacturing Practice"

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