Projects

Validation transformation from C&Q to ASTM E2500

NNE helped streamline Pfizer's verification systems.

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.

Projects

Quality strategy for biopharmaceutical manufacturing

Read about the quality and verification principles behind it.

TechTalk

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

  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. Ideally, it is best to have continuous process verification and control where process parameters are adjusted to keep processes on target. To achieve this ideal state, the...

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 .

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.

TechTalk

3 key approaches to pharma manufacturing control strategy

It is also key for equipment and facility qualification, process performance qualification, process validation, an ongoing process verification program, and a 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 qualification and validation programs, and finally, for continual improvement activities.

TechTalk

Creating value from big data in pharma manufacturing| TechTalk

A 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

Speed up single use changeover with this one simple method | TechTalk

 All of these verifications need to be performed within a classified environment (Grade C or D) so there is minimal external contamination and bioburden. These external verifications can also be scheduled so that any failures can be fixed without impacting the operational critical path 2.

Torben Bygvraa Rasmussen | NNE

Expert in: Applied manufacturing science Six Sigma Tolerance analysis (DFSS) Quality by Design (QbD) Statistical process control (SPC) Design of Experiments (DoE) Sampling for process validation and continued process verification What is your view on the industry?