STERILITY ASSURANCE
Sterility Assurance
DEVELOPING YOUR CONTAMINATION CONTROL STRATEGY (CCS)
Humanim approach is to leverage your cross-functional team to co-develop the Contamination Control Strategy (CCS) for your site(s). With our respective teams’ expertise in Sterility Assurance, our approach to CCS, our experience in change management, we work together to develop an approach which will strengthen Sterility Assurance on your site(s) to gain in efficiency while meeting regulatory expectations.
OPPORTUNITIES
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CCS offers the opportunity to reduce your sterility assurance related deviations (e.g., EM excursions, factory losses, APS failure, production down-time, release cycle-time)
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Your organization wants to strengthen sterility assurance collective knowledge to support sustainable operational performance while continuously meeting health authority expectations
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Your Company wants to meet evolving regulatory requirement in the most efficient and pragmatic manner. You are looking on how to define the structure and the granularity of the CCS document to meet your compliance and performance objectives
POINTS OF ATTENTION
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As the CCS is meant to be holistic, one risk is to develop a very complex and long document where the overall purpose and sense gets difficult to understand
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The CCS should not be a pure compliance document staying on the shelf
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The CCS is often seen as a quality/sterility assurance experts reserved domain. It should actually be the result of a cross functional exercise
THE HUMANIM "STERILITY ASSURANCE" OFFER
Strategic plan for the evolution of skills
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Helping companies identify the skills they need to be effective, sustainable and evolving
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Build a development plan
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Mentoring
Setting up mentoring adapted to the specific needs and situations of the company's women and men
APPROACH AND
SUPPORT Process
Alignment on CCS strategic intention
> Holistic review based on “Pyramid approach” and 16 Contamination Control Strategy items
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Shopfloor review of installations and documentation
> Agree on the general structure and the level of granularity
> Integrate existing QRM tools and existing data/validations
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> Highlight continuous improvement actions
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> Accept that risk appreciation is subjective and should be performed by a multidisciplinary team
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Co-construction to develop a fit-for-purpose deliverable
> Support of experts on each item of the CSS
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> Mentoring
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> Periodic review of improvement actions
Support for deployment of continuous improvement actions
THE ADVANTAGES AND BENEFITS
OF HUMANIM EXPERTISE
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An approach based on co-construction of the CCS document with your teams
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Experience in technical mentoring
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Capabilities in change management including cultural aspects
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Several experiences in operations (GMP, Production, Regulatory inspections, etc.)
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Extensive and cross-functional Sterility Assurance expertise of the Humanim Community
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Ability to have a holistic view to facilitate in prioritization of remediation actions