An unnamed source told Le Soleil that during his address at the CQV
conference, Cardinal Ouellet spoke about the need to support women who are considering abortion, a fact omitted by most of Ouellet's critics who insist his declaration lacked compassion and pastoral vision.
(7.) Because road capacity is assumed fixed, cqV
might be more precisely referred to as "short-run total variable cost."
Alberdingk-Boley * BWAY * Cardinal Color * CINIC America * CQV
* Evonik Hanse * Fuji Silysia Chemical * Huntsman Advanced Materials * ICG Specialty Chemicals * Monument Chemical * OPC Polymers * Orion Engineered Carbons * RUTGERS Group * Shamrock Technologies * Southeastern Performance Minerals * Toyobo * WPC Technologies
The most modern variant of process validation is Continuous Quality Verification (CQV), which promises the best of PAT (Process Analytical Technology) and QbD in an integrated control strategy as portrayed by ASTM E2537.
While no single control strategy on its own may be able to effectively ensure 100% fluid integrity, an integrated manufacturing/quality approach borrowing from QbD principles and integrating CQV may be suitable to ensure fluid integrity of biocontainers and negate the need to rely on factory leak testing as a release test.
HIGHLY EFFECTIVE COMMISSIONING, QUALIFICATION & VALIDATION (CQV) STRATEGY
* The CQV work was organized for speed and efficiency by breaking down responsibilities into smaller units than usual, enabling more work to be dome in parallel.
Many projects have cleared the hurdles of engineering and construction, only to struggle during CQV
. With this in mind, a strong emphasis was placed on pre-planning and scheduling of all post construction licensure-critical activities.
The goal of Process Analytical Technology (PAT) and Quality by Design (QbD) is to obtain sufficient process understanding to build a cause-and-effect model that improves process control and moves us towards Continuous Quality Verification (CQV) and real-time release of an end product without requiring final quality testing.
So, software systems are required for collection and access to all data types for contextualization and analysis that enables improved process understanding and control on the path towards CQV and real-time release.
We can extract from the FDA's guidance published in late 2008 that process validation and CQV are actually a lifestyle, not an event.