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Projects

Validation transformation from C&Q to ASTM E2500

NNE helped streamline Pfizer's verification systems.

Tags: GMP and compliance Americas

Projects

cGMP biotech development and pilot plant

Read how NNE set up a risk- and science-based verification system for UCB Pharma’s GMP-compliant facility for biomanufacturing.

Tags: Biotech and API Facility design Process engineering Europe

Projects

Quality strategy for biopharmaceutical manufacturing

Read about the quality and verification principles behind it.

Tags: Biotech and API GMP and compliance Asia

TechTalk

Data-based road map to continuous control strategy and real-time release | TechTalk

Many pharmaceutical manufacturers strive for continued product verification , but by turning the attention to continuous process control instead brings many advantages. Many pharmaceutical manufacturers are working towards continued process verification to live up to health authority expectations. Verification is a passive act, where the process is estimated to live up to specifications, without any adjustment of process parameters. This wou...

Services

Automation and IT consulting and design

We help you introduce new solutions such as electronic batch records (EBR), process analytical technology (PAT), and continuous process verification (CPV) in your plant or in your company.

Tags: Automation and IT

TechTalk

The value of control strategy for legacy products | TechTalk

No matter the established success of a pharmaceutical product, regulatory authorities still expect continued process verification of these hot drugs. However, health authorities expect companies to perform continued process verification (CPV – stage 3) on these legacy products regardless of their lengthy establishment. The 3-step process continuous process verification .

Tags: Front-end

TechTalk

The missing link of single-use implementation

Operators must be trained in handling and assembling tube sets and verification of connection integrity to prove system closure. Regardless of what is chosen, there is importance in how the connection verification is documented and how both the identification of components and a proper set-to-set interface is verified.

Tags: Single-use

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Pharma engineering abbreviations cheat sheet

ty CA Compressed Air CAD Computer Aided Design CBER Centre for Biologics Evaluation and Research (FDA) CBP Continuous Bioprocessing CDER Centre for Drug Evaluation and Research (FDA) cGMP Current Good Manufacturing Practice CIP Cleaning-in-place CNC Controlled Not Classified CP Continuous Processing CPP Critical Process Parameter CPV Continued Process Verification CQA Critical Quality Attributes CU Clean Utility D...

TechTalk

Creating value from big data in pharma manufacturing| TechTalk

The data-based control strategy can be expanded to support inline release and continuous process verification (CPV) by defining requirements for the process indicators that will guarantee sufficient capability of the CQA.

TechTalk

3 key approaches to pharma manufacturing control strategy

This is true for: conceptual process and facility design studies, defining user requirement specifications, equipment and facility qualification, process performance qualification, process validation, continued (ongoing) process verification program, as well as the daily manufacturing and control program. However it is also useful to define the continued ongoing process verification , for process automation projects, for smarter and leaner...