Validation engineering according to 5m Partner
5m Partner offers the health and beauty industries and their suppliers and service providers customized validation engineering services
Our services for the health and beauty industries and their suppliers will be cover to the following areas:
- Medicines,
- Pharmaceutical raw materials (API/active substances, excipients, intermediates…),
- OTC,
- Cosmetics,
- Medical devices,
- Food supplements,
- Suppliers and service providers (storage, transport, cleaning…).
Our validation engineering services are designed to fit your business and are conducted according to your quality standards:
- European GMP and US GMP,
- GDP,
- IPEC guidelines,
- Excipients guideline,
- 21 CFR 210, 211, 820, part 4…
- OECD GLP,
- ISO 13485,
- ISO 15378,
- ICH Q7, ICH Q8, ICH Q9, ICH Q10, ICH Q11.
5m Partner, customized validation engineering services
The technical and regulatory expertise of our senior consultants guarantees you:
5m Partner offers healthcare and beauty industries and their suppliers pragmatic validation services for their various processes and facilities:
At your request and according to your needs, we produce or co-build:
- Your validation policy,
- Review and optimization of your validation policy,
- Your validation strategy and its implementation at different stages:
- According to the traditional approach to validation:
- Design qualification,
- Installation qualification,
- Operational qualification,
- Performance qualification,
- For periodic requalifications / revalidations,
- For the continuous verification of your processes (CPV Continuous Process Verification),
- For the continuous monitoring of your processes throughout their life cycle (ongoing process verification during lifecycle).
- According to the traditional approach to validation:
An « à la carte » support fitting your needs:
- The development of a criticality analysis methodology / risk analysis,
- The building of your criticality analysis / risk analysis tools,
- The implementation of your own methodology as an independent third party.
We also support you in the development of your validation documentation architecture and provide assistance in the drafting of qualification/validation documents as part of:
- The organisation of your validation document architecture and definition of the associated management rules,
- Provision of document templates to be completed by you,
- The review and optimization of your validation documents,
- Complete drafting of your validation documents.
Our services cover the following documents :
- Validation Master Plan,
- Qualification / validation procedures,
- Protocols and test sheets
- Qualification / validation reports,
- Non- conformances sheets …
Additional services offered by our experts
Depending on your needs, 5m Partner acts:
To assist your teams in the deployment
of all or part of your
qualification / validation actions:
- Supervision of test execution,
- Management of non-conformances,
- Decision support / definition of conclusions,
- Review of conclusions…
- As an additional resource,
- As a technical expert on a specific equipment or standard.
For the training and support
of your validation teams:
- In validation methodology,
- In related tools,
- In the requirements and regulatory changes applicable to your activities and projects.
Check out our other areas of expertise
