Quality Control/Quality Assurance

Develop a relevant design space without full factorial DoE.

Plant closures, product recalls prompt FDA re-evaluation of GMP enforcement efforts.

What you need to know about USP chapter <63>.

Apply risk management principles to monitor outsourced activities.

USP is advancing efforts to develop a guidance for evaluating bioassays.

Twelve lessons of what to do and what not to do to avoid quality problems.

It is important that all stages of the audit be given an equal measure of attention.

The two-one-sided t-test compares the equivalency of two data sets.

Conducting a FMEA analysis is a good first step in a risk-based approach for determining the need for a filter integrity test.

If risk assessments only identify "the usual suspects," the process will not add much value.

ICH Q9 encourages companies to apply the concept of quality risk management. Easier said than done.

A better method for trend analysis than CUSUM and control charts.

Without a rigorous discussion of the pros and cons of QbD, its tremendous benefits will be lost.

Follow a risk-based approach to maintain a state of control.

The 45 comments submitted raised concerns about legacy products and ongoing process monitoring.

A method to evaluate the relative cleanability of new products.

QbD for QA? Try a two-step approach

To stave off quality issues associated with production processes, a centralized and enterprise-wide quality management initiative must be enforced.

A clear oversight framework for biomarker clinical laboratory tests used in personalized medicine is required.

The FDA's revised process validation guidance manages to explain the underlying concepts of Quality by Design without every using the phrase.

Well-designed experiments can reduce the risk of coming to an incorrect conclusion during a process characterization, assay validation, or process validation study.

A centralized quality control strategy may be the best solution.

Statistical methods for calculating confidence intervals, tolerance intervals, and capability analysis to reduce out-of-specification situations.

Risk mitigation should be a key aspect of any contract manufacturing organization's business strategy.

GMPs in Phase 1 is more important now than ever before.