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SONNE delivers structured and reliable validation

We adhere to our customer’s quality and compliance procedures, or if the customer prefers, we offer to use our own platform. The keys to our approach, when delivering process and machine risk assessment, qualification, and validation, include:

ISO Standards

With Lead Auditor expertise, both workflow and quality will meet ISO standards relevant to the given industry.

Good Manufacturing Practice

Our quality platform complies with Good Manufacturing Practice.

GAMP 5

By design building quality control into all stages of the manufacturing process.

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SONNE ensures consistency in quality according to process and machine requirements, including:

  • Specifications
  • Risk assessment
  • Design review
  • Software testing
  • FAT and SAT
  • IQ-OQ-PQ
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We are dedicated to ensure our customers comply with relevant standard and regulations

Our consultants stay up-to-date with knowledge and procedures via training and courses.

We ensure that machinery and processes comply with Good Manufacturing Practice (cGMP) and Good Automated Manufacturing Practice (GAMP)

Our approach to compliance delivers solid technical documentation, required for CE-marking.

Within Pharma and Medico our consultants ensure compliance with relevant standards and regulations required by EMA and FDA.

Case: Medico/Pharma packing machine

SONNE proudly assisted its customer, a sub-supplier to one of the largest international pharmaceutical manufacturers located in Denmark, in the design and hand-over of a packing machine.

The pharmaceutical manufacturer was launching a new product. A new packing machine had to be developed, ready for product launch, and therefore keeping the time schedule was essential. Due to resource constraints, our customer asked SONNE to assist with the development and design of a new case packer module for the packaging machine – effectively scaling up the sub-supplier’s project team to reduce the time schedule.

SONNE had 4 employees tasked with the assignment, including work on 3D design, 2D documentation and design specification documentation, as well as one Team Lead supporting the project management. The 3D design and documentation of the case packer module only took 4 months.

The entire packaging machine consists of 28 modules and is designed to meet good manufacturing practices (GMP). More than 600 installation and functionality requirements were included in the User Requirement Specification and had to be tested during the factory and site acceptance test.

The customer had one of SONNE’s Quality & Compliance Specialists assist with a variety of tasks, including:

  • Building a customer keyword database with a pretest plan and traceability matrix.
  • Design specification review in collaboration with the end-customer.
  • Writing test plans and performing review with the end-customer.
  • Performing FAT, including deviation closure and report.
  • Performing SAT, including deviation closure and report.

These tasks were performed for the entire 28 module machine in collaboration with both sub-supplier and end-customer.

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Packing Machine Automatiseret Til Pharma Og Medico.
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