Health industries, your guarantee of quality compliance

Co-management of compliance / quality process optimization

Do any of these apply to you?

  • You are regularly inspected and audited and you want to implement a real “Inspection readiness” strategy?
  • You want to optimize your quality processes?
  • Your products, your markets, your premises or your processes are evolving and you want to measure and control the quality impacts of these changes?
  • You are going to be producing for a new market. You are integrating new products or new processes on your site. You have to build a new workshop / room / laboratory?
Co-management or support of your quality compliance

Our actions of compliance co-piloting or quality processes optimization are meant for health and beauty industries, in France, Europe and the rest of the world as well as their suppliers and providers:

  • Medicines,
  • Pharmaceutical raw materials (API/active substances, excipients, intermediates…),
  • OTC,
  • Cosmetics,
  • Medical devices,
  • Food supplements,
  • And your suppliers and service providers (storage, transport, cleaning, ...).
Support according to the applicable standards

Our quality audits are carried out according to the standards applicable to your products:

  • European GMP and US GMP,
  • GDP,
  • IPEC guidelines,
  • Excipients guideline,
  • 21 CFR 210, 211, 820, part 4…
  • OECD GLP,
  • ISO 13485,
  • ISO 22000,
  • ISO 22716,
  • ISO 15378,
  • Synadiet quality charter…

5m Partner, personalized quality support services to meet your needs

To meet your expectations, 5m Partner offers an "à la carte" assistance menu:

  • Gap analysis to assess the compliance of your Quality Management System with standards and quality requirements,
  • Skills development and coaching of your teams: regulations, specific inspection / audit requirements, behavior, etc.

During audits / inspections

  • Deviation and CAPA management,
  • Change control,
  • Documentation management,
  • Staff training / qualification process
  • Control strategy (product, environment…) during your products life cycle,
  • Annual Product Reviews,
  • Internal and supplier quality audit program,
  • Validation and revalidation strategy,
  • Risk assessment,
  • Out Of Specification (OOS) and Out Of Trend (OOT) results management,
  • Reagents management…
  • Specifics and regulatory requirements linked to changes or developments in progress (product, market, premises, processes, ...),
  • Practical and organizational consequences of the prospective change or novelty,
  • Implementation of the related policy,
  • Application of various risk analysis tools,
  • Assessment and analysis of the impact of this new market / product on your quality organization,
  • Project planning and assistance in writing a master plan,
  • Focused quality assistance for the design of your products, markets, premises and processes to be modified,
  • Writing of your users’ requirements and specifications,
  • Revue de dossiers APS,
  • Mise à jour de votre documentation…

Our quality support method

Our human skills

The 5m Partner team offers you:

  • Additional resources to:
    • Assist you or take charge of one of your quality activities, on your site or in our offices,
    • Build or deploy all or part of your quality action plans.
  • Mentoring and / or coaching actions, personalized professional support over a predefined period for:
    • Objectives of the mentee / coachee and the company,
    • Areas of development of knowledge, know-how and interpersonal skills,
    • Results indicators,
    • Rules of ethics: confidentiality…,
    • Mentoring / coaching sessions,
    • Assessment of results against defined indicators of success:
      • Halfway through,
      • At the end of the course.
Our technical and regulatory expertise

Our senior consultants and trainers guarantee you:

  • A pragmatic and smiling approach to quality,
  • Systematic adaptation to your operating methods and deadline requirements,
  • Consideration of the regulatory requirements applicable to your products and activities,
  • Knowledge of your business, your products and your processes
  • The experience of our consultants on similar quality projects.
Related services

Check out our other areas of expertise