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Regulation Compliance

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, Good Manufacturing Practice, and GAMP 5.
SONNE ensures consistency in quality according to process and machine requirements, including:

SpecificationsRisk assessmentDesign reviewSoftware testingFAT and SATIQ-OQ-PQ

Require validation services, or have questions?

0608_B

Bjarne Ravndal Andreasen
Head of Quality & Compliance
ba@sonne.com
+45 36 56 76 34

0608_B

Bjarne Ravndal Andreasen
Head of Quality & Compliance
ba@sonne.com
+45 36 56 76 34

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

Quality control is by design built into all stages of the manufacturing process.

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

Quality control is by design built into all stages of the manufacturing process.

We are dedicated to ensuring 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).

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

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

Case: Medico/Pharma packing machine

Packing Machine Design and Hand-over

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.

Compliance Specialist Assistance

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

Packing Machine Design and Hand-over

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.

Compliance Specialist Assistance

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

The tasks were performed on all 28 sections of the machine in collaboration with the sub-supplier and end-customer.

Q&C_ISO
Packing machine automatiseret til pharma og medico.
Packing Machine Automatiseret Til Pharma Og Medico.
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