Validation and qualification of pharmaceutical warehouse and equipment. Practical aspects

Validation and qualification of pharmaceutical warehouse and equipment. Practical aspects

Details

  • Start date: 09 December 2022
  • Start time: 10:00 (Kyiv)
  • Finish date: 09 December 2022
  • Finish time: 14:00 (Kyiv)
  • Duration: 1 day, 4 academic hours
  • Break: yes
  • Category: Production (GMP)
  • Format: Streaming
  • Online broadcast available: yes
  • Venue: Online
  • Language class: Русский
  • Cost of education:

    180 Euro (pre-sale until 02.12.2022) + 36 Euro for each next participant;

    200 Euro (from 02.12.2022) + 40 Euro for each next participant

     

    In a programme:

    1. The concept of validation and qualification:

    – types of validation;

    – stages of validation;

    – validation documentation;

    – validation work planning, VMP;

    – scheduled and unscheduled revalidation;

    – organization of validation and qualification at the enterprise;

    – documents regulating validation (risk analysis, methods);

    – equipment for qualification and monitoring;

    – logging the results of storage monitoring. Graphs and diagrams.

    2. Validation of storage facilities with storage conditions (+15-+25С; +2-+8С), mapping:

    – development of a validation plan and protocol;

    – project qualification (DQ);

    – installation qualification (IQ);

    – performance qualification (OQ);

    – performance qualification (PQ).

    – Validation report:

    • processing validation data;

    • conclusions from warehouse validation;

    • an example of a report on the validation (qualification) of a pharmacy warehouse;

    • examples of room mapping.

    3. Validation (qualification) of equipment (thermal containers):

    – development of a validation plan and protocol;

    – installation qualification (IQ);

    – performance qualification (OQ);

    – performance qualification (PQ).

    – Validation report:

    • processing qualification data;

    • conclusions in the qualification of equipment;

    • an example of a validation report (qualification) of equipment.

    4. Development of methods for monitoring drug storage conditions.

    5. Discussion, answers to questions.