Pharmaceutical water systems as an element of technical/engineering systems of a pharmaceutical enterprise

Pharmaceutical water systems as an element of technical/engineering systems of a pharmaceutical enterprise

Details

  • Start date: 28 November 2022
  • Start time: 10:00 (Kyiv)
  • Finish date: 29 November 2022
  • Finish time: 14:00 (Kyiv)
  • Duration: 2 days, 8 academic hours
  • Break: yes
  • Category: Production (GMP)
  • Format: Streaming
  • Online broadcast available: yes
  • Venue: Online
  • Language class: Русский
  • Cost of education:

    320 Euro + 288 Euro for each next participant

     

    The following international standards form the basis of the Training Seminar Program:

    — EU Directive - Directive 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the Quality of Water Intended for Human Consumption ;

    — GMP EU Rules – Guidelines to Good Manufacturing Practice Medicinal Products for Humane and Veterinary Use (part of VOL.4 – The Rules Governing Medicinal Products in the European Union) – annex 1 (2022) updated requirements;

    — EMA Guide – Guideline on the Quality of Water for Pharmaceutical Use (EMA/CHMP/CVMP/QWP/496873/2018, 2020)

    — WHO Guidelines – Production of water for injection by means other than distillation (TRS 1025, 2020);

    — WHO Guidelines – Good manufacturing practices: water for pharmaceutical use (TRS 1033, 2021);

    — Memo PIC / S – Aide-Memoire. Inspection of Utilities (PI 009, 2021);

    — US FDA Guide – Guide to Inspections of High Purity Water Systems (2016);

    — Standard ISO 3696 – Water for analytical laboratory use;

    — Updated monographs of international pharmacopoeias EPh, USP, JP;

    — Monograph USP – Water for Pharmaceutical Purpose (2020);

    — Pharmaceutical quality system – ICH Q10 Pharmaceutical Quality System.

     

    Main questions of the program:

    • Introduction to the program and topic

    • The concept of proper technical/engineering systems as the technical basis for quality assurance of pharmaceutical products during their production and their management as PQS processes

    • Water systems for pharmaceutical purposes (WPU - water for pharmaceutical use)

    • Source water for obtaining water for pharmaceutical purposes - the requirements of modern international guidelines, the concept of source water (Source Water) and drinking water quality (Potable Water / Drinking Water), requirements for quality and monitoring

    • Water for pharmaceutical use (WPU) - types and quality requirements for water for use in the production of pharmaceutical products (PW, HPW, WFI, WPE), water as a pharmaceutical product itself, and water for use in pharmaceutical quality control laboratories

    • Conditions for the use of different types of WPU in the production of pharmaceutical products (taking into account the types of products and purposes of use)

    • Processing methods, water purification systems, acceptable methods for obtaining WPU - requirements for obtaining WPU in updated and new guidelines. Applicable methods for pre-treatment, acceptable methods for obtaining pharmaceutical water with the required quality attributes. Specifics, features of the technology for removing groups of contaminants, limitations and potential operational problems, operational controls and monitoring measures applicable to the water treatment systems used

    • WPU (water storage and distribution systems): design, engineering, Good practices for water systems, system sanitization and bioburden control as steps the life cycle of systems (taking into account the principles of PQS), taking into account specific aspects, requirements in modern guidelines and approaches for their possible implementation

    • Qualification and validation of systems for the receipt, storage and distribution of WPU, main phases in accordance with the requirements of updated and new guidelines, subsequent continuous system monitoring and review of water systems (system reviews)

    • Practical trainings on the issues under consideration

    • Pharmaceutical production clean process media associated with pharmaceutical water systems = pure steam (pure/clean steam) – requirements in updated and new guidelines for clean steam, clean steam quality, use, production and distribution systems, monitoring

    • End of the program. Discussion of controversial issues