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Packaging & Process
CONSULTING

grundlegende Fähigkeiten Chemie, Physik und Mathematik

Subject Matter Expert

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  • Cold chain / temp- controlled shipping systems

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  • Development of packaging platforms

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  • Gap Analysis (Internal Audits for NB and HA inspection readiness)

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Expertise

  • ICH guideline Q9, Q10, Q11, and Q13

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  • ISO 14971

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  • Packaging Standards, e.g., ISO, DIN, ASTM and ISTA

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  • IT technology -Asset Management

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  • Child resistance packaging

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  • People Management and Coaching to high performer attitude

Breaking news: Amendment 1 of ISO 11607-1 issued in Sept. 2023 requires a Risk Management for packaging system.

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  • Therefore, risk evaluation and risk control are commonly recognized as essential parts of risk management of packaging and finally a sterile Medical Device and applicable in: 

 

  • Design and development phase (e.g. D-FMEA)

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  • Validation phase (Performance and stability testing)

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  • Usability evaluation (U-FMEA)

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  • Process validation (P-FMEA)

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  • Production phase (e.g. In-Process-Control)

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  • Packaging system changes (update of Risk Assessment might be necessary)

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Our SOP consistently follows a holistic approach and comprehensively covers the Packaging Development phases.

 

Risk Management SOP and templates already available.
 

Effective and efficient management of packaging development activities and ensure compliance to ISO 11607-1.

Why external support?

  • We are experts in packaging design control and processes for Medical Devices and Pharma packaging.

 

  • bleyco swiss consulting supports you in changing perspectives and challenging the status quo.

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