Archemin

Advice & reporting for the chemical and pharmaceutical industries

Good Distribution Practice

Monday 30 September 2019 from 13h30 to 17h30, Archemin will present during the 4th UPIP-VAPI annual certification session which will be held at the J&J European Distribution Center Rue du Bois de la hutte 5 , B-7110 La Louvière. The Belgian industrial pharmacists association regularly organises very accessible training sessions for its senior professional members as well as for its junior colleagues who wish to become acquainted with the basics of GDP.

The Archemin talk will focus on those aspects which are essential for small scale pharmaceutical wholesalers and distributors:

  • Overview of the legal background: Guidelines of 7 March 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01 ) updated 5 November 2013 (2013/C 343/01)
  • Essential parts of a GDP quality system
  • Effective Standard Operating Procedure writing with special attention for GDP
  • The role and function description of the Responsible Person for GDP

For more information and online registration visit https://www.upip-vapi.be/

Topics which will be covered:

    Warehousing

    • Critical attributes and parameters
    • Warehouse qualification 
    • Maintenance

    Developing the quality manual

    • Identify the requirements
    • Risk based approach
    • Examples of different operational models
    • Continuous improvement

    Standard Operating Procedures

    • Quality standards
    • Process understanding
    • Basic principles of SOP writing

    Risk

    • Risk level determination
    • Risk minimisation, risk containment

    Audits

    • Quality standards
    • Risk-based auditing 
    • Root cause analysis
    • The link with the quality system

    CAPAs

    • CAPA types
    • CAPA development
    • CAPA resolution and follow-up
    • CAPA handling as a means for continuous improvement