Health industries, your guarantee of quality compliance

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 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…).
According to your quality standards

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:

  • Understanding of quality standards and their application,
  • Knowledge of your business, your products and your processes
  • A pragmatic approach to validation,
  • A tried and testedproven qualification/validation method,
  • An assimilation of the approach by your teams,
  • And therefore the effectiveness of the validation.

5m Partner offers healthcare and beauty industries and their suppliers pragmatic validation services for their various processes and facilities:

  • Manufacturing
  • Packaging
  • Cleaning
  • Sterilization
  • Analytical methods …
At your request

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).
An « à la carte » support fitting your needs

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.
For your validation document structure (architecture)

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.
For the following 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:

As an independent third party

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…
To support your teams :
  • As an additional resource,
  • As a technical expert on a specific equipment or standard.
In consulting support

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.
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