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ICG lyophilization

In recent years, the lyophilization process has continued to occupy an increasingly important; it stands out as the most interesting process to ensure good stability especially for those products of biotechnology during storage and distribution to the patient.

But this process is complex, demanding, it requires numerous technical, scientific and large "know how".

This face an inescapable environmental and societal energy challenge.

- How lyophilization process of a highly complex and so demanding in energy can prepare and integrate these changes?
- What the experts, leaders, decision makers can imagine, define a vision for this vital process in the development of medicines of tomorrow?

Solutions exist; but only a proactive and collaborative approach between all actors in the sector will ensure the results and progress up to the challenge.

It is in this context that the A3P Association brought together experts to create the A3P Freeze.

The main objective of the ICG Freeze Thermal Mapping is to allow the freeze professionals meet to share and make an inventory of the practices of "mapping" set |uvre lyophilization.

Deliverables:

  • Undertake a survey of the thermal mapping practices.
  • Communicating the results of l¹enquête in The Wave No. 49 Special Bioproduction
  • Communicating progress of the ICG in The Wave No. 50 Special Congress A3P
  • Present during the days A3P LYOPHILIZATION 2017 a draft on "good thermal mapping practices lyophilization"
  • Develop a practice notebook "good thermal mapping practices freeze" after l¹événement A3P.

 

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Commit to share
Transmit and progress together
Promoting innovation

The A3P Association is a major player in the pharmaceutical and biotechnology industry.
Created in 1986, it contributes to the good development of the production of medicines and clean and sterile equipment, it runs a network of professionals 21 000, manufacturers and suppliers, as part of International Congress and technical days.

It now has over 1700 members who share their technical experience, scientific and regulatory.

More info on video (Versiongb here )


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  • ICG A3P Annex 1

    ICG annexe1

    Dice 2013 October, during the final round table of the International Congress A3P in Biarritz, A3P was interested in the revision of Annex 1. A GIC was established 2014 start by ten experts extended to 20 below after a call motivated to participate and clarify its objectives during its first meeting on January 7 2014:

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  • ICG A3P eCompliance

    ICG eCompliance 01

    Creating a new GIC A3P eCompliance

    The evolution of technologies and modes of "delivery" computing (Cloud, mobile computing ..), the context of merger / acquisition of pharmaceutical companies, the changing global landscape of information processing, the multiplication of stakeholders in the IT sector (industry), the increasing maturity of the users are all factors that challenge the organization and the processes associated with computer systems or automation in the pharmaceutical industry and biotechnology.

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  • ICG A3P Freeze

    You can not load Article (ID: 25) into Itself

  • GIC regulatory A3P

    GIC regulatory,

    ICG A3P Regulatory

    Relying on the expertise of members of the regulatory texts and to respond to a request of its members, A3P created a Common Interest Group (CIG) regulations.

    This GIC A3P regulation has two main objectives:

    • A goal Proactive →The review of the regulatory texts in draft.
    • A goal Educational →Explain the approved Statutory Instrumentsto make them more understandable.

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  • ICG A3P Single Use Systems

    gic addition

    ICG A3P Single Use Systems

    Single-use systems (SUS: single-use systems) grow considerably to meet the industry requirements: ease and speed of implementation, indirect response to cleaning validation issues, flexibility, costs reduced infrastructure ...

    The development of the adoption of these systems still poses more questions on various topics:

    • Quality: extractable / relarguables, interactions containment, systems integrity, quality control of materials, process validation using such solutions ...
    • Technologies: disposable sensors, interfacing and interconnections with conventional equipment, physical limitations of the SUS (flow, pressure, ...), control / monitoring systems (proprietary or not), implementation (use validation) new single-use technologies entering the market.
    • Environment: How do these systems can be integrated into sustainable development programs and minimization of environmental impacts ...?
    • Supply: how to ensure security of supply throughout the product chain, from the raw material for manufacturing polymers to delivery to the end customer SUS? Is it possible to develop standards in order to set up double sourcing? ...
    • Life Cycle Management: User-supplier partnership in the management of SUS product life cycle
    • Economic Comparison of installation and operating costs of SUS versus conventional systems, control cost trends, ...
    • Regulatory changes, particularly on the initial validation and continuous of these technologies.


    A3P decided to create an ICG on this issue so as to allow the various industries concerned to discuss these issues and arrive on common consensus to facilitate the implementation and use of these technologies.

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  • ICG A3P Barrier Technology

    ICG technoBarriere 01

    Creating a GIC A3P Barrier Technology

    Appendix 1 under review should strongly recommend the absence of direct human intervention in the critical area during the aseptic manufacture of sterile therapeutic products and therefore the use of barrier technology. It is likely that this will be the first step towards the prohibition of direct human presence for new aseptic manufacturing units in the next revision of Annex 1 unless strongly justified exception.

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  • ICG A3P Cleaning Validation

    ICG validationdunettoyage

    ICG A3P Cleaning Validation

    Following the application entry in the 1er October 2015 15 of the new Annex "Qualification and Validation" Good Practices for Manufacturing of health products for human and veterinary use, many of you rework the specific part of the subchapter dedicated 10 the Cleaning Validation. Indeed, this Section now has 15 subparagraphs, when the previous version dated 2001 there were only 7. This regulatory strengthening highlights major changes on this subject: Acceptance criteria based on the CRP approach, very marked distinction between manual cleaning receipts and automated ones, need for very precise rational and well argued as to choice of (these) product (s) Worst case, in the choice of areas to be sampled.

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