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News and Events:

GMP
Good Manufacturing Practice

Welcome to the website about GMP Guideline

   Good manufacturing practice Guidelines describes general principles. Implementation of these principles may support you with organization of production in accordance with GMP requirements.
   Manufacturing practices is not described particularly in the Guidelines. However, on this site you can find some sources providing good description of manufacturing practices. If you fail to find required information online, you may ask colleagues from the forum to support you with your issues.

   Information on this website is structured according to the following sections:

  1. Business Management Practice section describes system of management of a pharmaceutical company based on the process approach.
  2. Marketing section describes identifying the needs of the market.
  3. Market Needs are met by the products developed in the course of its research and development.
  4. Production Capacity Project is designed after product development. Pharmaceutical Production Design is regulated by Good Engineering Practice (GEP).
  5. Purchase, Storage, Production and Quality Control are regulated by the requirements of Good Manufacturing Practice (GMP).
  6. Storage and Distribution are regulated by Good storage practices (GSP) and Good distribution practice (GDP).
  7. Automation of logistics, production, quality control and assurance, production are regulated by Good automation manufacturing Practice (GAMP).

The requirements of good manufacturing practice have their own specifics depending on the country. On this site you can find information on GMP requirements in: USA, EU, UK, Australia, Canada, UA, RU, WHO.

The Good Manufacturing Practices requirements are described in detail in the following sections:

Utilities
    Air
    Nitrogen
    Water
    Steam
    Clean Room
        Requirements
        Design
        HVAC
        Qualification
        Monitoring

Process Equipment
    Aseptic manufacturing
        Isolator
        Steam sterilizers

    Non-sterile solid forms
       Mixers
       Granulators
       Tablet press

    Non-sterile semi-solid dosage forms
       Grinding
       Homogenization
       Degassers
       Filling
       Cartoner

GMP in the world
US
WHO
EU
UK
UA
RU
Australia
Canada

 

Qualification and Validation

 

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