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Projects

Qualification under tight shutdown deadline

Read how NNE assists CSL Behring in its qualification activities during the annual summer shutdown to make sure that production restarts on time, every time.

Tags: GMP and compliance Europe

Projects

Qualification ensures successful GMP inspection

Read how NNE’s qualification effort helped ensure the facility passed GMP inspection.

Tags: Biotech and API GMP and compliance Europe

Projects

Qualification and validation of GMP vaccine facility

Find out how NNE’s qualification and validation team helped GSK Biologicals’ build a new GMP vaccine plant in time to meet seasonal production demands.

Tags: Biotech and API Europe

Projects

GMP training enables tablet plant qualification

Read how our GMP training enabled Kyong Dong's own qualification team to qualify the company’s new tablet plant, which is its first GMP-compliant facility.

Tags: Oral solid dosage GMP and compliance Asia

Projects

Risk-based approach to GMP process validation

NNE's solution was a turnkey facility and support with the complete qualification and process validation – from validation master plan up to the start of commercial production. NNE applied a risk-based approach to the qualification as well as to the process validation. Being there from start to finish After preparing all qualification phases and the process validation, the NNE team supervised and documented the results of the first batches...

Tags: Process engineering GMP and compliance Asia

Projects

Validation transformation from C&Q to ASTM E2500

Read how the large ASTM implementation made commissioning and qualification more cost-effective.

Tags: GMP and compliance Americas

TechTalk

What lies ahead for fill and finish projects? | TechTalk

Factory acceptance tests and qualification pre-tests are also standardized, therefore need significantly less times for tests. Where several months have been needed so far, it is now possible – even for more complex machines – to complete the preparation work for the qualification within weeks. Quote Modular standardization also ensures a high degree of planning security during the qualification phase. The procedures for the execution of...

Projects

GMP facility for production of biomaterials | NNE

Key to success Geistlich Pharma selected NNE as contractor for the process part and we took responsibility for the project initiation, the subsequent engineering activities, equipment procurement, installation and full qualification from design qualification to operational qualification up to performance qualification support.

Tags: Biotech and API Facility design Process engineering Europe

Projects

Transferring device production across borders

Installation without production shutdown NNE supported Novo Nordisk throughout the project – from the basic design to performance qualification and handover of the new production equipment. To reduce the commissioning and qualification time, NNE applied a risk-based approach to ensure maximum focus on high-probability/high-impact risks. And to strengthen qualification efficiency between China and Denmark, an electronic test system, eTIMS, was...

Tags: Biotech and API Assembly and pack Automation and IT Project execution GMP and compliance Europe Asia

Projects

Lifecycle support in vaccine facility expansion

Quote project In the vaccine facility, a number of NNE employees have been involved in a variety of supporting tasks for years, including training local suppliers to meet international requirements, managing contractors and providing services within commissioning and qualification . NNE was responsible for the preparation of validation plans, installation and operational qualification (IQ/OQ) protocols for clean utilities (purified water, wate...

Tags: GMP and compliance Asia