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5M PARTNER

65 rue Aristide Briand, 27400 Acquigny, France

+33 (0)2 32 09 52 52

• A range of flexible and exclusively dedicated services:

- Healthcare industries: pharmaceutical, chemical, cosmetics and medical device manufacturers,
- To their suppliers: raw materials (API, excipients and intermediates), primary and printed packaging articles, service providers (analysis, cleaning, metrology, guarding, transport, sterilization, interim ...).

• 5 main lines of "tailor-made" services:
- Quality audit (on your site or that of your suppliers and partners),
- Consulting, support of quality projects and personalized coaching,
- Training (face-to-face or e-learning, educational games ...),
- Qualification-validation,
- Communication.

5m partner

PDF presentation 5M Partner- PDF presentation 5M Partner (English Version)

Some examples of achievements:

• Quality audit of the processes of:
- Production,
- Control (on-site and analytical subcontracting),
- Sterilization,
- Cleaning,
- Pharmaceutical storage and distribution,
- Transport and distribution,
- Archiving ...

 

• Quality audits:
- Internal,
- Suppliers,
- Shared vendor quality audits ...

 

• Consulting, support of quality projects and personalized coaching:
- cGMP-FDA compliance of various production sites (drugs, medical gases, biotechnologies, medical devices, APIs, cosmetics ...),
- Assistance before, during and after inspection by the supervisory authorities (compliance, coaching, action plan, responses to authorities, injunctions ...),
- Writing Quality Manuals,
- Compliance with the ICH Q10,
- Optimization deviation management process and CAPA,
- Quality Risk Management (ICH Q9):
- Implementation of the associated policy,
- Application of different risk analysis tools,
- Support of your Product Quality Reviews,
- Methodology for determining the expiration / validity of the reagents,
- Writing of opening or modification files of pharmaceutical establishments,
- Optimization of document systems and revamping of batch files,
- Writing and translation of supplier specifications ...

 

• Training (organization empowered to deliver CPD programs):
- Design and / or animation of tailor-made training modules in face-to-face, e-learning or self-training (MyPower),
- Assessment of achievements, habilitations,
- Construction of training plans,
- Conception of educational games (Rubis, Useful Revisions of the GMP in Interactive and Sympathetic form ...),
- Design and implementation of empowerment processes (samplers, ZAC stakeholders, trainers and tutors ...).

 

• Qualification-validation:
- Accompaniment in your validation and revalidation strategy,
- Construction and / or realization of criticality analyzes,
- Accompaniment in the qualification and requalification of equipment,
- Writing cleaning validation protocols, sterilization ...
- Supervision of tests in your premises or those of your suppliers.

 

• Communication:
- Quality tools: "GMPs, instructions", "5 Words and more ...", "Maqadm Health, quality audit matrices" ...
- Design of welcome booklets and quality information media: posters ...
- Self-training,
- The 5m Partner benchmarks

 


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