GMP Specifications

WHO defines Good Manufacturing Practices (GMP) as “that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.

 

The authority of GMP defines the quality standards, practising of these standards are controlled by CE in Europe and FDA in America. Since of Turkey is a candidate country for European Union membership, our work is based on GMP standards.

 

International standards that control manufacturing facility establishment and processes for acceptable quality level under proper safe conditions.

 

The standards cover – but not limited to – these basic areas:

 

  • Architectural Scheme

 

  • Electro-Mechanical Scheme

 

  • Ventilation Scheme

 

  • Water Treatment

 

  • Quality Management

 

  • Document Control

 

  • Process Control

 

  • Workflow Schemes

 

  • Facility and Safety Management

 

  • Material Management

 

  • Personal Management