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?
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:
- Pharmaceutical raw materials (API/active substances, excipients, intermediates…),
- Medical devices,
- Food supplements,
- And your suppliers and service providers (storage, transport, cleaning, ...).
Our quality audits are carried out according to the standards applicable to your products:
- European GMP and US GMP,
- 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
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 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.